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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01201356
Registration number
NCT01201356
Ethics application status
Date submitted
10/09/2010
Date registered
14/09/2010
Titles & IDs
Public title
Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis
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Scientific title
A Single Arm, Open-label, Multicenter Study Evaluating the Long-term Safety and Tolerability of 0.5 mg Fingolimod (FTY720) Administered Orally Once Daily in Patients With Relapsing Forms of Multiple Sclerosis
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Secondary ID [1]
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0
2010-020515-37
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Secondary ID [2]
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CFTY720D2399
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Relapsing Forms of Multiple Sclerosis
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Fingolimod
Experimental: Fingolimod 0.5 mg/day - Open-label fingolimod 0.5 mg, taken orally once daily
Treatment: Drugs: Fingolimod
0.5 mg/day
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Intervention code [1]
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0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Parts I and II: Number of Participants With Adverse Events, Serious Adverse Event, and Death
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Assessment method [1]
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Analysis of absolute and relative frequencies for Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC) to demonstrate that Fingolimod 0.5 mg/day is safe in patients with relapsing forms of Multiple Sclerosis (MS) through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed.
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Timepoint [1]
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Baseline (Part I) to Month 6 Follow-up (Part II), up to 8 years
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Secondary outcome [1]
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Part I: Aggregate Annualized Relapse Rates (ARR) From First Dose of Fingolimod
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Assessment method [1]
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Annualized relapse rate (ARR) is defined as the number of all relapses (including both confirmed and unconfirmed relapses) experienced during a specific period of time adjusted to a one-year period. ARR is calculated as follows: (total number of all relapses) / (total number of days in the study for all patients for that specific period of time) x 365.25. Month 0 is the first dose of fingolimod study drug among all studies in which patient participated. Only descriptive analysis performed.
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Timepoint [1]
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Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months)
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Secondary outcome [2]
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Part I: Number of Participants With Relapses (Confirmed and Unconfirmed) From First Dose of Fingolimod
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Assessment method [2]
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A relapse is defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (\<37.5°C) or infection.
In Study Part One, a relapse must be confirmed by an Expanded Disability Status Scale (EDSS) certified Physician within 7 days of the onset of symptoms. A relapse is confirmed when it is accompanied by an increase of at least half a step (0.5) on the EDSS or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS). Month 0 is the first dose of fingolimod study drug among all studies in which patient participated. Only descriptive analysis performed.
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Timepoint [2]
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Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months)
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Secondary outcome [3]
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Part I: Annualized Rates of New or Newly Enlarging T2 Lesions (ARneT2) Compared With First Dose of Fingolimod
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Assessment method [3]
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Annualized rate of new/newly enlarging T2 lesions (ARneT2) is defined as the number of new or newly enlarging T2 lesions experienced during a specific period of time adjusted to a one-year period. ARneT2 was calculated as follows: (total number of new/newly enlarging T2 lesions) / (total number of days in the study for all patients for that specific period of time) x 365.25.Month 0 is the first dose of fingolimod study drug among all studies in which patient participated. Only descriptive analysis performed.
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Timepoint [3]
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Month 0 (Core Baseline) to End of Study (an average of Month 156)
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Secondary outcome [4]
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Part I: Change From First Dose of Fingolimod in Total T2 Lesions Volume
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Assessment method [4]
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Total volume of T2 lesions was summarized by presenting descriptive statistics for change from first dose of fingolimod baseline values by visit.
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Timepoint [4]
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Month 3 to End of Study (Study Completion Visit)
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Secondary outcome [5]
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Part I: Change From First Dose of Fingolimod in Total T1 Hypointense Lesions Volume
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Assessment method [5]
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T1 hypointense lesion (black hole) volume was summarized by presenting descriptive statistics for change from first dose of fingolimod baseline values by visit.
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Timepoint [5]
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Month 3 to End of Study (Study Completion Visit)
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Secondary outcome [6]
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Part I: Percent Brain Volume Change (PBVC) Relative to First Dose of Fingolimod
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Assessment method [6]
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Descriptive statistics on percent brain volume change from first dose of fingolimod baseline were presented by visit. A negative change from baseline indicates improvement.
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Timepoint [6]
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Month 3 to Month 156
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Secondary outcome [7]
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Part I: Annualized Rate of Brain Atrophy (ARBA) Relative to First Dose of Fingolimod
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Assessment method [7]
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The annualized rate of brain volume change is an "averaged annual percentage change" in brain volume. ARBA was calculated as: ARBA = \[(SIENA/100+1) \^ (365.25/#days)-1\]\*100 where SIENA=(Vk/V0-1)\*100 and Vk is the brain volume at time k, V0 is the brain volume at time 0 and k is the total number of days in the study for all patients for that specific period of time) × 365.25. Only descriptive analysis performed.
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Timepoint [7]
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Month 3 to Month 156
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Secondary outcome [8]
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Part I: Number of Participants With Confirmed 6-month Disability Progression After First Dose of Fingolimod
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Assessment method [8]
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Disability progression was defined based on an increase in the EDSS score by 1.5 point for patients with a first dose of fingolimod (FDF) baseline EDSS score of 0, 1 point for patients with FDF baseline EDSS of \>=1 and \<=5.5, and by 0.5 points for patients with an FDF baseline EDSS\>5.5, confirmed after 6 months and all intermediate EDSS assessments. A 6-month confirmed disability progression was defined as a 6-month sustained increase from the reference (potential onset of progression) value in the EDSS scores. i.e., every EDSS score (scheduled or unscheduled) within a 6-month duration after the first progression should meet the progression criteria as specified above. The confirmation could only happen at a scheduled visit and in the absence of a relapse. Only descriptive analysis performed.
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Timepoint [8]
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Month 12 to Month 156
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Secondary outcome [9]
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Part I: Number of Participants With Categorized Change From First Dose of Fingolimod in Expanded Disability Status Scale (EDSS) Overall Score
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Assessment method [9]
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The EDSS is a scale for assessing neurological impairment in MS (Kurtzke 1983) including (1) a series of scores in each of eight functional systems, and (2) the EDSS steps (ranging from 0 (normal) to 10 (death due to MS). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Based on the assessment of each FS, the participant's overall score is categorized as Improvement, Stable or Deterioration.
If baseline EDSS score is \<=5, improvement is indicated by an EDSS score change of \<= -1, stable is indicated by an EDSS score change of \> -1 and \<= 0.5, deterioration is indicated by an EDSS score change of \> 0.5; if baseline EDSS score is \> 5, improvement is indicated by an EDSS score change of \<= -0.5, stable is indicated by an EDSS score change of \> -0.5 and \<= 0, deterioration is indicated by an EDSS score change of \> 0. Only descriptive analysis performed.
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Timepoint [9]
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Month 3 to Month 6 Follow-up
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Secondary outcome [10]
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Part I: Change From First Dose of Fingolimod in Expanded Disability Status Scale (EDSS)
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Assessment method [10]
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The EDSS is a scale for assessing neurological impairment in MS (Kurtzke 1983) including (1) a series of scores in each of eight functional systems, and (2) the EDSS steps (ranging from 0 (normal) to 10 (death due to MS). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Based on the assessment of each FS, the participant's overall score is determined between 0 to 10. A negative change from baseline indicates improvement. Only descriptive analysis performed.
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Timepoint [10]
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Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months)
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Eligibility
Key inclusion criteria
Key
- Patients who have completed selected ongoing or planned trials with FTY720.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Premature permanent discontinuation of a previous fingolimod study.
* Pregnant or nursing (lactating) women.
* Women of child-bearing potential, UNLESS they are using two birth control methods, at least 1 of which must be hormonal contraception, tubal sterilization, partner's vasectomy or intrauterine device.
* Chronic disease of the immune system, other than multiple sclerosis, which may require immunosuppressive treatment.
* Diabetic patients with moderate or severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy and uncontrolled diabetic patients with HbA1c > 8%.
* Active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or have positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests.
* Previous treatment with cladribine, cyclophosphamide or mitoxantrone.
* Treatment with immunoglobulins and/or monoclonal antibodies (including Natalizumab) in the past 3 months during the previous fingolimod study:
* Any of the following cardiovascular conditions that have developed during the previous fingolimod study:
* Myocardial infarction within the past 6 months prior to entry in the extension study or with current unstable ischemic heart disease;
* Cardiac failure (Class III, according to New York Heart Association Classification) or any severe cardiac disease as determined by the investigator;
* Arrhythmia requiring current treatment with Class III antiarrhythmic drugs (e.g., amiodarone, bretylium, sotalol, ibutilide, azimilide, dofetilide)
* History or presence of a third degree AV block
* Proven history of sick sinus syndrome or sino-atrial heart block
* Known history of angina pectoris due to coronary spasm or Raynaud's phenomenon
* Any of the following pulmonary conditions during the previous fingolimod study:
* Severe respiratory disease or pulmonary fibrosis diagnosed (during the previous fingolimod study)
* Active tuberculosis
* Alcohol abuse, chronic liver disease during the previous fingolimod study.
The patient must have participated in a previous fingolimod trial to be eligible to participate in this trial.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/09/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
19/10/2018
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Sample size
Target
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Accrual to date
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Final
4125
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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Novartis Investigative Site - Camperdown
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Recruitment hospital [2]
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Novartis Investigative Site - Chatswood
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Recruitment hospital [3]
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Novartis Investigative Site - Kogarah
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Recruitment hospital [4]
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Novartis Investigative Site - Liverpool
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Recruitment hospital [5]
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Novartis Investigative Site - North Gosford
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Recruitment hospital [6]
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Novartis Investigative Site - Woodville
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Recruitment hospital [7]
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Novartis Investigative Site - Box Hill
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Recruitment hospital [8]
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Novartis Investigative Site - Fitzroy
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Recruitment hospital [9]
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Novartis Investigative Site - Heidelberg
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Recruitment hospital [10]
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Novartis Investigative Site - Parkville
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2067 - Chatswood
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Recruitment postcode(s) [3]
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2217 - Kogarah
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Recruitment postcode(s) [4]
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2170 - Liverpool
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Recruitment postcode(s) [5]
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2250 - North Gosford
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Recruitment postcode(s) [6]
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5011 - Woodville
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Recruitment postcode(s) [7]
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3128 - Box Hill
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Recruitment postcode(s) [8]
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3065 - Fitzroy
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Recruitment postcode(s) [9]
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3084 - Heidelberg
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Recruitment postcode(s) [10]
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3050 - Parkville
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Recruitment outside Australia
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United States of America
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Alabama
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California
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District of Columbia
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Florida
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Georgia
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Kansas
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Prague 5
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Teplice
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Tampere
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Finland
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Turku
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France
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Cedex
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Bron
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CAEN Cedex
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France
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France
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Dijon
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Montpellier
Query!
Country [83]
0
0
France
Query!
State/province [83]
0
0
Nice Cedex 1
Query!
Country [84]
0
0
France
Query!
State/province [84]
0
0
Paris Cedex 13
Query!
Country [85]
0
0
France
Query!
State/province [85]
0
0
Poissy
Query!
Country [86]
0
0
France
Query!
State/province [86]
0
0
Rennes
Query!
Country [87]
0
0
France
Query!
State/province [87]
0
0
St Herblain
Query!
Country [88]
0
0
France
Query!
State/province [88]
0
0
Strasbourg Cedex
Query!
Country [89]
0
0
France
Query!
State/province [89]
0
0
Toulouse cedex 9
Query!
Country [90]
0
0
Germany
Query!
State/province [90]
0
0
Baden-Wuerttemberg
Query!
Country [91]
0
0
Germany
Query!
State/province [91]
0
0
Bavaria
Query!
Country [92]
0
0
Germany
Query!
State/province [92]
0
0
Nordrhein-Westfalen
Query!
Country [93]
0
0
Germany
Query!
State/province [93]
0
0
Aachen
Query!
Country [94]
0
0
Germany
Query!
State/province [94]
0
0
Aalen
Query!
Country [95]
0
0
Germany
Query!
State/province [95]
0
0
Abensberg
Query!
Country [96]
0
0
Germany
Query!
State/province [96]
0
0
Achim
Query!
Country [97]
0
0
Germany
Query!
State/province [97]
0
0
Alzenau
Query!
Country [98]
0
0
Germany
Query!
State/province [98]
0
0
Aschaffenburg
Query!
Country [99]
0
0
Germany
Query!
State/province [99]
0
0
Augsburg
Query!
Country [100]
0
0
Germany
Query!
State/province [100]
0
0
Bad Honnef
Query!
Country [101]
0
0
Germany
Query!
State/province [101]
0
0
Bad Krozingen
Query!
Country [102]
0
0
Germany
Query!
State/province [102]
0
0
Bad Mergentheim
Query!
Country [103]
0
0
Germany
Query!
State/province [103]
0
0
Bad Neustadt
Query!
Country [104]
0
0
Germany
Query!
State/province [104]
0
0
Bamberg
Query!
Country [105]
0
0
Germany
Query!
State/province [105]
0
0
Bayreuth
Query!
Country [106]
0
0
Germany
Query!
State/province [106]
0
0
Berlin
Query!
Country [107]
0
0
Germany
Query!
State/province [107]
0
0
Bielefeld
Query!
Country [108]
0
0
Germany
Query!
State/province [108]
0
0
Boblingen
Query!
Country [109]
0
0
Germany
Query!
State/province [109]
0
0
Bochum
Query!
Country [110]
0
0
Germany
Query!
State/province [110]
0
0
Bogen
Query!
Country [111]
0
0
Germany
Query!
State/province [111]
0
0
Bonn
Query!
Country [112]
0
0
Germany
Query!
State/province [112]
0
0
Buchholz in der Nordheide
Query!
Country [113]
0
0
Germany
Query!
State/province [113]
0
0
Buchholz
Query!
Country [114]
0
0
Germany
Query!
State/province [114]
0
0
Chemnitz
Query!
Country [115]
0
0
Germany
Query!
State/province [115]
0
0
Dillingen
Query!
Country [116]
0
0
Germany
Query!
State/province [116]
0
0
Dresden
Query!
Country [117]
0
0
Germany
Query!
State/province [117]
0
0
Düsseldorf
Query!
Country [118]
0
0
Germany
Query!
State/province [118]
0
0
Emden
Query!
Country [119]
0
0
Germany
Query!
State/province [119]
0
0
Emmendingen
Query!
Country [120]
0
0
Germany
Query!
State/province [120]
0
0
Erbach
Query!
Country [121]
0
0
Germany
Query!
State/province [121]
0
0
Erfurt
Query!
Country [122]
0
0
Germany
Query!
State/province [122]
0
0
Erlangen
Query!
Country [123]
0
0
Germany
Query!
State/province [123]
0
0
Essen
Query!
Country [124]
0
0
Germany
Query!
State/province [124]
0
0
Frankfurt
Query!
Country [125]
0
0
Germany
Query!
State/province [125]
0
0
Freiburg
Query!
Country [126]
0
0
Germany
Query!
State/province [126]
0
0
Greifswald
Query!
Country [127]
0
0
Germany
Query!
State/province [127]
0
0
Grevenbroich
Query!
Country [128]
0
0
Germany
Query!
State/province [128]
0
0
Hamburg
Query!
Country [129]
0
0
Germany
Query!
State/province [129]
0
0
Hannover
Query!
Country [130]
0
0
Germany
Query!
State/province [130]
0
0
Heidelberg
Query!
Country [131]
0
0
Germany
Query!
State/province [131]
0
0
Hennigsdorf
Query!
Country [132]
0
0
Germany
Query!
State/province [132]
0
0
Herborn
Query!
Country [133]
0
0
Germany
Query!
State/province [133]
0
0
Homburg
Query!
Country [134]
0
0
Germany
Query!
State/province [134]
0
0
Ibbenbueren
Query!
Country [135]
0
0
Germany
Query!
State/province [135]
0
0
Itzehoe
Query!
Country [136]
0
0
Germany
Query!
State/province [136]
0
0
Jena
Query!
Country [137]
0
0
Germany
Query!
State/province [137]
0
0
Kaltenkirchen
Query!
Country [138]
0
0
Germany
Query!
State/province [138]
0
0
Kassel
Query!
Country [139]
0
0
Germany
Query!
State/province [139]
0
0
Koeln
Query!
Country [140]
0
0
Germany
Query!
State/province [140]
0
0
Koln
Query!
Country [141]
0
0
Germany
Query!
State/province [141]
0
0
Krefeld
Query!
Country [142]
0
0
Germany
Query!
State/province [142]
0
0
Landshut
Query!
Country [143]
0
0
Germany
Query!
State/province [143]
0
0
Lappersdorf
Query!
Country [144]
0
0
Germany
Query!
State/province [144]
0
0
Leipzig
Query!
Country [145]
0
0
Germany
Query!
State/province [145]
0
0
Lohr am Main
Query!
Country [146]
0
0
Germany
Query!
State/province [146]
0
0
Ludwigshafen
Query!
Country [147]
0
0
Germany
Query!
State/province [147]
0
0
Magdeburg
Query!
Country [148]
0
0
Germany
Query!
State/province [148]
0
0
Mainz
Query!
Country [149]
0
0
Germany
Query!
State/province [149]
0
0
Mannheim
Query!
Country [150]
0
0
Germany
Query!
State/province [150]
0
0
Marburg
Query!
Country [151]
0
0
Germany
Query!
State/province [151]
0
0
Muenchen
Query!
Country [152]
0
0
Germany
Query!
State/province [152]
0
0
Muenster
Query!
Country [153]
0
0
Germany
Query!
State/province [153]
0
0
München
Query!
Country [154]
0
0
Germany
Query!
State/province [154]
0
0
Nagold
Query!
Country [155]
0
0
Germany
Query!
State/province [155]
0
0
Neu-Ulm
Query!
Country [156]
0
0
Germany
Query!
State/province [156]
0
0
Neuburg an der Donau
Query!
Country [157]
0
0
Germany
Query!
State/province [157]
0
0
Neuruppin
Query!
Country [158]
0
0
Germany
Query!
State/province [158]
0
0
Oldenburg
Query!
Country [159]
0
0
Germany
Query!
State/province [159]
0
0
Osnabrück
Query!
Country [160]
0
0
Germany
Query!
State/province [160]
0
0
Pforzheim
Query!
Country [161]
0
0
Germany
Query!
State/province [161]
0
0
Potsdam
Query!
Country [162]
0
0
Germany
Query!
State/province [162]
0
0
Prien
Query!
Country [163]
0
0
Germany
Query!
State/province [163]
0
0
Rostock
Query!
Country [164]
0
0
Germany
Query!
State/province [164]
0
0
Ruelzheim
Query!
Country [165]
0
0
Germany
Query!
State/province [165]
0
0
Rüdersdorf
Query!
Country [166]
0
0
Germany
Query!
State/province [166]
0
0
Schwarzenbruck
Query!
Country [167]
0
0
Germany
Query!
State/province [167]
0
0
Schwendi
Query!
Country [168]
0
0
Germany
Query!
State/province [168]
0
0
Siegen
Query!
Country [169]
0
0
Germany
Query!
State/province [169]
0
0
Sinsheim
Query!
Country [170]
0
0
Germany
Query!
State/province [170]
0
0
Stade
Query!
Country [171]
0
0
Germany
Query!
State/province [171]
0
0
Stuttgart
Query!
Country [172]
0
0
Germany
Query!
State/province [172]
0
0
Teupitz
Query!
Country [173]
0
0
Germany
Query!
State/province [173]
0
0
Trier
Query!
Country [174]
0
0
Germany
Query!
State/province [174]
0
0
Tübingen
Query!
Country [175]
0
0
Germany
Query!
State/province [175]
0
0
Ulm
Query!
Country [176]
0
0
Germany
Query!
State/province [176]
0
0
Unterhaching
Query!
Country [177]
0
0
Germany
Query!
State/province [177]
0
0
Wendlingen
Query!
Country [178]
0
0
Germany
Query!
State/province [178]
0
0
Wermsdorf
Query!
Country [179]
0
0
Germany
Query!
State/province [179]
0
0
Wiesbaden
Query!
Country [180]
0
0
Germany
Query!
State/province [180]
0
0
Wuerzburg
Query!
Country [181]
0
0
Germany
Query!
State/province [181]
0
0
Wuppertal
Query!
Country [182]
0
0
Germany
Query!
State/province [182]
0
0
Würzburg
Query!
Country [183]
0
0
Greece
Query!
State/province [183]
0
0
Evros
Query!
Country [184]
0
0
Greece
Query!
State/province [184]
0
0
GR
Query!
Country [185]
0
0
Greece
Query!
State/province [185]
0
0
Athens
Query!
Country [186]
0
0
Greece
Query!
State/province [186]
0
0
Heraklion Crete
Query!
Country [187]
0
0
Greece
Query!
State/province [187]
0
0
Patras
Query!
Country [188]
0
0
Greece
Query!
State/province [188]
0
0
Thessaloniki
Query!
Country [189]
0
0
Guatemala
Query!
State/province [189]
0
0
Guatemala City
Query!
Country [190]
0
0
Hungary
Query!
State/province [190]
0
0
HUN
Query!
Country [191]
0
0
Hungary
Query!
State/province [191]
0
0
Budapest
Query!
Country [192]
0
0
Hungary
Query!
State/province [192]
0
0
Debrecen
Query!
Country [193]
0
0
Hungary
Query!
State/province [193]
0
0
Gyor
Query!
Country [194]
0
0
Hungary
Query!
State/province [194]
0
0
Miskolc
Query!
Country [195]
0
0
Hungary
Query!
State/province [195]
0
0
Pecs
Query!
Country [196]
0
0
Hungary
Query!
State/province [196]
0
0
Szeged
Query!
Country [197]
0
0
Hungary
Query!
State/province [197]
0
0
Szekesfehervar
Query!
Country [198]
0
0
Hungary
Query!
State/province [198]
0
0
Veszprem
Query!
Country [199]
0
0
Ireland
Query!
State/province [199]
0
0
Dublin 4
Query!
Country [200]
0
0
Ireland
Query!
State/province [200]
0
0
Dublin
Query!
Country [201]
0
0
Israel
Query!
State/province [201]
0
0
Ashkelon
Query!
Country [202]
0
0
Israel
Query!
State/province [202]
0
0
Haifa
Query!
Country [203]
0
0
Israel
Query!
State/province [203]
0
0
Ramat Gan
Query!
Country [204]
0
0
Israel
Query!
State/province [204]
0
0
Sefad
Query!
Country [205]
0
0
Italy
Query!
State/province [205]
0
0
AT
Query!
Country [206]
0
0
Italy
Query!
State/province [206]
0
0
BA
Query!
Country [207]
0
0
Italy
Query!
State/province [207]
0
0
BG
Query!
Country [208]
0
0
Italy
Query!
State/province [208]
0
0
BO
Query!
Country [209]
0
0
Italy
Query!
State/province [209]
0
0
BS
Query!
Country [210]
0
0
Italy
Query!
State/province [210]
0
0
CA
Query!
Country [211]
0
0
Italy
Query!
State/province [211]
0
0
CH
Query!
Country [212]
0
0
Italy
Query!
State/province [212]
0
0
CT
Query!
Country [213]
0
0
Italy
Query!
State/province [213]
0
0
FE
Query!
Country [214]
0
0
Italy
Query!
State/province [214]
0
0
FG
Query!
Country [215]
0
0
Italy
Query!
State/province [215]
0
0
FI
Query!
Country [216]
0
0
Italy
Query!
State/province [216]
0
0
GE
Query!
Country [217]
0
0
Italy
Query!
State/province [217]
0
0
IS
Query!
Country [218]
0
0
Italy
Query!
State/province [218]
0
0
Lazio
Query!
Country [219]
0
0
Italy
Query!
State/province [219]
0
0
MI
Query!
Country [220]
0
0
Italy
Query!
State/province [220]
0
0
PA
Query!
Country [221]
0
0
Italy
Query!
State/province [221]
0
0
PR
Query!
Country [222]
0
0
Italy
Query!
State/province [222]
0
0
PV
Query!
Country [223]
0
0
Italy
Query!
State/province [223]
0
0
RA
Query!
Country [224]
0
0
Italy
Query!
State/province [224]
0
0
RM
Query!
Country [225]
0
0
Italy
Query!
State/province [225]
0
0
SI
Query!
Country [226]
0
0
Italy
Query!
State/province [226]
0
0
TO
Query!
Country [227]
0
0
Italy
Query!
State/province [227]
0
0
UD
Query!
Country [228]
0
0
Italy
Query!
State/province [228]
0
0
VA
Query!
Country [229]
0
0
Italy
Query!
State/province [229]
0
0
VI
Query!
Country [230]
0
0
Italy
Query!
State/province [230]
0
0
VR
Query!
Country [231]
0
0
Italy
Query!
State/province [231]
0
0
VT
Query!
Country [232]
0
0
Italy
Query!
State/province [232]
0
0
Napoli
Query!
Country [233]
0
0
Jordan
Query!
State/province [233]
0
0
Irbid
Query!
Country [234]
0
0
Korea, Republic of
Query!
State/province [234]
0
0
Korea
Query!
Country [235]
0
0
Korea, Republic of
Query!
State/province [235]
0
0
Seoul
Query!
Country [236]
0
0
Malaysia
Query!
State/province [236]
0
0
Wilayah Persekutuan
Query!
Country [237]
0
0
Malaysia
Query!
State/province [237]
0
0
Kuala Lumpur
Query!
Country [238]
0
0
Netherlands
Query!
State/province [238]
0
0
CK
Query!
Country [239]
0
0
Netherlands
Query!
State/province [239]
0
0
Amsterdam
Query!
Country [240]
0
0
Netherlands
Query!
State/province [240]
0
0
Blaricum
Query!
Country [241]
0
0
Netherlands
Query!
State/province [241]
0
0
Enschede
Query!
Country [242]
0
0
Netherlands
Query!
State/province [242]
0
0
Gouda
Query!
Country [243]
0
0
Netherlands
Query!
State/province [243]
0
0
Nieuwegein
Query!
Country [244]
0
0
Netherlands
Query!
State/province [244]
0
0
Nijmegen
Query!
Country [245]
0
0
Netherlands
Query!
State/province [245]
0
0
Rotterdam
Query!
Country [246]
0
0
Netherlands
Query!
State/province [246]
0
0
Sittard-Geleen
Query!
Country [247]
0
0
Netherlands
Query!
State/province [247]
0
0
Tilburg
Query!
Country [248]
0
0
Norway
Query!
State/province [248]
0
0
Lillehammer
Query!
Country [249]
0
0
Norway
Query!
State/province [249]
0
0
Molde
Query!
Country [250]
0
0
Norway
Query!
State/province [250]
0
0
Stavanger
Query!
Country [251]
0
0
Panama
Query!
State/province [251]
0
0
Panama City
Query!
Country [252]
0
0
Peru
Query!
State/province [252]
0
0
Callao
Query!
Country [253]
0
0
Peru
Query!
State/province [253]
0
0
Lima
Query!
Country [254]
0
0
Poland
Query!
State/province [254]
0
0
Bialystok
Query!
Country [255]
0
0
Poland
Query!
State/province [255]
0
0
Bydgoszcz
Query!
Country [256]
0
0
Poland
Query!
State/province [256]
0
0
Gdansk
Query!
Country [257]
0
0
Poland
Query!
State/province [257]
0
0
Katowice
Query!
Country [258]
0
0
Poland
Query!
State/province [258]
0
0
Lodz
Query!
Country [259]
0
0
Poland
Query!
State/province [259]
0
0
Poznan
Query!
Country [260]
0
0
Poland
Query!
State/province [260]
0
0
Warszawa
Query!
Country [261]
0
0
Portugal
Query!
State/province [261]
0
0
Amadora
Query!
Country [262]
0
0
Portugal
Query!
State/province [262]
0
0
Coimbra
Query!
Country [263]
0
0
Portugal
Query!
State/province [263]
0
0
Lisboa
Query!
Country [264]
0
0
Portugal
Query!
State/province [264]
0
0
Porto
Query!
Country [265]
0
0
Portugal
Query!
State/province [265]
0
0
Setubal
Query!
Country [266]
0
0
Romania
Query!
State/province [266]
0
0
Bucharest
Query!
Country [267]
0
0
Romania
Query!
State/province [267]
0
0
Craiova
Query!
Country [268]
0
0
Romania
Query!
State/province [268]
0
0
Targu Mures
Query!
Country [269]
0
0
Russian Federation
Query!
State/province [269]
0
0
Samara Region
Query!
Country [270]
0
0
Russian Federation
Query!
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Martin
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TUR
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Poole
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Swindon
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Funding & Sponsors
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Name
Novartis Pharmaceuticals
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Ethics approval
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Summary
Brief summary
The purpose of this study was to collect long-term safety and tolerability, long-term efficacy, and health outcome data in all patients currently ongoing in the fingolimod multiple sclerosis clinical development program. This study combined all currently ongoing Phase II and III fingolimod extension studies as well as ongoing and newly planned studies into one single long-term extension protocol that provided patients with continuous treatment until fingolimod was registered, commercially available, and reimbursed in the respective countries.
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Trial website
https://clinicaltrials.gov/study/NCT01201356
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Trial related presentations / publications
Cohen JA, Tenenbaum N, Bhatt A, Zhang Y, Kappos L. Extended treatment with fingolimod for relapsing multiple sclerosis: the 14-year LONGTERMS study results. Ther Adv Neurol Disord. 2019 Sep 25;12:1756286419878324. doi: 10.1177/1756286419878324. eCollection 2019.
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Public notes
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Contacts
Principal investigator
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.clinicalstudydatarequest.com
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/56/NCT01201356/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/56/NCT01201356/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01201356