Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00731692
Registration number
NCT00731692
Ethics application status
Date submitted
7/08/2008
Date registered
11/08/2008
Titles & IDs
Public title
This Was an Open-label, Single-arm Extension Study (CFTY720D2306E1) to a Double-blind, Randomized Multicenter, Placebo-controlled, Parallel-group Core Study (CFTY720D2306) in PPMS.
Query!
Scientific title
A Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5mg Fingolimod Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple Sclerosis and An Open-label, Single-arm Extension Study to the Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of0.5 mg FTY720 Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple Sclerosis
Query!
Secondary ID [1]
0
0
2007-002627-32
Query!
Secondary ID [2]
0
0
CFTY720D2306
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
INFORMS
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Primary Progressive Multiple Sclerosis
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - FTY720
Treatment: Drugs - Placebo
Experimental: FTY720D 0.5 mg - Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment
Placebo comparator: Placebo - Cohort 1 and 2: Patients randomized to placebo continued on placebo after re-randomization
Experimental: FTY720D 1.25 mg switch to 0.5 mg - Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment on Nov 2009
Treatment: Drugs: FTY720
Fingolimod capsules at doses of 1.25 mg (prior to implementation of Amendment 5) and 0.5 mg (after Amendment 5) were administered orally once daily
Treatment: Drugs: Placebo
Matching placebo capsules were administered orally once daily
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Kaplan-Meier Estimate of the Risk of 3-month Confirmed Disability Progression Based on Composite Endpoint
Query!
Assessment method [1]
0
0
3-month sustained increase from Baseline in EDSS (at least 1 point increase from Baseline for patients with a Baseline value of 5 or less or at least 0.5 point increase from Baseline for patients with a Baseline value of 5.5 or more) or 3-month sustained increase of at least 20% from BL in the time taken to complete the timed 25-foot walk test (25' TWT); or 3-month sustained increase of at least 20% from BL in the time taken to complete the 9-HPT. The 25' TWT is a quantitative measure of lower extremity function. The EDSS is a scale assessing neurologic impairment, including a series of scores in each of 8 functional systems: Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. The score ranges from 0 (normal) to 10 (death due to MS)). The 9-hole peg test (9-HPT) is a quantitative measure of upper extremity (arm and hand) function.
Query!
Timepoint [1]
0
0
up to 36 months after the last patient was randomized
Query!
Secondary outcome [1]
0
0
Kaplan-Meier Estimate of the Risk of 3- Month Confirmed Disability Progression Based on Expanded Disability Status Scale (EDSS)
Query!
Assessment method [1]
0
0
The Expanded Disability Status Scale (EDSS) is a scale for assessing neurologic impairment in MS (Kurtzke 1983) and includes a series of scores in each of 8 functional systems and 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. Fatigue is not included in the Cerebral score of the EDSS. The score ranges from 0 (normal) to 10 (death due to MS)
Query!
Timepoint [1]
0
0
up to 36 months after the last patient was randomized
Query!
Secondary outcome [2]
0
0
Percent Change From Baseline in Brain Volume at Month 36
Query!
Assessment method [2]
0
0
The percent change from Baseline in brain volume was analyzed using a random coefficients model. The model included: 1) fixed effects: treatment and region and 2) continuous covariates: time, number of Gd enhancing lesions at Baseline, Baseline T2 volume, and normalized brain volume at Baseline. Time as a continuous covariate allowed for the estimation of different slopes and intercepts among treatment groups.
Query!
Timepoint [2]
0
0
Baseline to month 36
Query!
Secondary outcome [3]
0
0
Kaplan Meier Estimate -Percentage of Participants With 3- Month Confirmed Disability Progression Based on 9-HPT.
Query!
Assessment method [3]
0
0
The 9-HPT is a quantitative measure of upper extremity (arm and hand) function designed and validated for evaluation of MS patients. N= Total number of patients included in the analysis
Query!
Timepoint [3]
0
0
up to 36 months after the last patient was randomized
Query!
Secondary outcome [4]
0
0
Kaplan Meier Estimate -Percentage of Participants With 3- Month Confirmed Disability Progression Based on 25' TWT.
Query!
Assessment method [4]
0
0
The 25' TWT is a quantitative measure of lower extremity function designed and validated for evaluation of MS patients. N= Total number of patients included in the analysis
Query!
Timepoint [4]
0
0
up to 36 months after the last patient was randomized
Query!
Secondary outcome [5]
0
0
Number of New/Enlarging T2 Lesions Per Year Measured From Baseline to Month 36
Query!
Assessment method [5]
0
0
Inflammatory disease, as measured by number of new or newly-enlarging T2 lesions, was assessed by Magnetic resonance Imaging (MRI) scanning of the brain and full spinal cord. N= Total number of patients included in the analysis
Query!
Timepoint [5]
0
0
Baseline to 36 months
Query!
Secondary outcome [6]
0
0
Number of Gd-enhancing Lesions at Month 36
Query!
Assessment method [6]
0
0
Inflammatory disease, as measured by number of T1 Gd-enhancing lesions, was assessed by MRI scanning of the brain and full spinal cord. N= Total number of patients included in the analysis
Query!
Timepoint [6]
0
0
Baseline to 36 months
Query!
Secondary outcome [7]
0
0
Percent Change in Total T2 Lesion Volume From Baseline to Month 36
Query!
Assessment method [7]
0
0
Inflammatory disease as measured by percent change in total T2 lesion volume (mm3) was assessed by MRI. N= Total number of patients included in the analysis
Query!
Timepoint [7]
0
0
Baseline to month 36
Query!
Secondary outcome [8]
0
0
Change From Baseline in the Patient Reported Indices in Multiple Sclerosis (PRIMUS-QoL Score)
Query!
Assessment method [8]
0
0
The quality of life scale contains 22 items. Each item will be given a score of 1 or 0. A score of 1 (or 0) indicates the presence (or absence) of the symptom or adverse quality of life. All 22 item scores will be summed to obtain a total score ranging from 0 (good) to 22 (poor), which is the PRIMUS QoL scale score
Query!
Timepoint [8]
0
0
Baseline, 36 months
Query!
Secondary outcome [9]
0
0
Change From Baseline in PRIMUS-Activities
Query!
Assessment method [9]
0
0
The activities subscale of PRIMUS contains 15 items and each item is given a score of 0 (able to do on own without difficulties), 1 (able to do on own with difficulties), or 2 (unable to do on own). All 15 items were summed to obtain a total score ranging from 0 (good) to 30 (poor).
Query!
Timepoint [9]
0
0
Baseline, 36 months
Query!
Secondary outcome [10]
0
0
Change From Baseline in Unidimensional Fatigue Impact (U-FIS) Score
Query!
Assessment method [10]
0
0
Unidimensional Fatigue Impact Scale (U-FIS), contains 22 patient-reported items that assess the impact of fatigue on cognitive, physical, and psychosocial functioning. Responses formed a single unidimensional scale measuring fatigue impact. The U-FIS was calculated and analyzed according to the U-FIS scoring manual. The U-FIS scale contains 22 items with 5 possible outcomes for each item. Two response categories (about half the time and a lot of the time) were combined into 1 category to obtain 4 possible outcomes: 0 (never), 1 (a little of the time), 2 (about half the time/a lot of the time), and 3 (all the time). The 22 condensed item scores were summed to obtain a total score ranging from 0 (no fatigue) to 66 (severe fatigue impact).
Query!
Timepoint [10]
0
0
Baseline, 36 months
Query!
Secondary outcome [11]
0
0
Change From Baseline in European Quality of Life - 5 Dimensions (EQ-5D Score)
Query!
Assessment method [11]
0
0
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Query!
Timepoint [11]
0
0
Baseline, 36 months
Query!
Secondary outcome [12]
0
0
Change From Baseline in Multiple Sclerosis Walking Scale (MSWS-12 Score)
Query!
Assessment method [12]
0
0
The Multiple Sclerosis Walking Scaleis a patient reported measure of walking quality (Hobart et al 2003), consisting of 12 items asking patients to rate the impact of MS upon their walking ability. Responses were captured on a 3-point scale ranging from 1 (Not at all) to 3 (A lot) for items 1 to 3 and on a 5-point scale ranging from 1 (not limited) to 5 (extremely) for items 4 to 12. All 12 item scores were summed to obtain a total score ranging from 12 (good) to 54 (poor) which is the MSWS-12 scale score. The total score was transformed to a 0 to 100 scale score. The MSWS-12 scale score will be transformed to a 0-100 scale score before any summaries or statistical analyses are performed. The transformed score is obtained by subtracting 12 and divided by 42 and multiplying by 100 (i.e., transformed scale score = (raw scale score- 12)/42\*100).
Query!
Timepoint [12]
0
0
Baseline, 36 months
Query!
Secondary outcome [13]
0
0
Blood Concentrations of Fingolimod and Fingolimod-phosphate
Query!
Assessment method [13]
0
0
Concentrations of fingolimod and fingolimod-phosphate in whole blood were determined by validated liquid chromatography methods with tandem mass spectrometry. The lower limits of quantification were 0.08 ng/ml for fingolimod and 0.1 ng/ml for fingolimod-phosphate.
Venous blood samples were collected for the analysis.
Query!
Timepoint [13]
0
0
Month 3 up to 36 months
Query!
Secondary outcome [14]
0
0
Change in MSFC Z-score and Subscale Scores From Baseline to Month 36
Query!
Assessment method [14]
0
0
The Multiple Sclerosis Functional Composite (MSFC) is a multidimensional clinical outcome measure that includes quantitative tests of leg function/ambulation (Timed 25-Foot Walk), arm function (9-Hole Peg Test), and cognitive function (Paced Auditory Serial Addition Test). The overall MSFC z-score as an average of the three standardized scores derived using baseline data pooled over each treatment arm as reference population. Higher scores reflect better neurological function and a positive change from Baseline indicates improvement.
Query!
Timepoint [14]
0
0
Baseline to Month 36
Query!
Eligibility
Key inclusion criteria
General
1. sign written informed consent prior to participating in the study
2. 25 through 65 years of age inclusive
3. females of childbearing potential must:
* have a negative pregnancy test at Baseline (prior to randomization) and
* use simultaneously two forms of effective contraception during the treatment and 3-months after discontinuation of study medication
Primary Progressive Multiple sclerosis.
1. diagnosis of primary progressive multiple sclerosis (according to the 2005 Revised McDonald criteria):
2. time since first reported symptoms between 2 and 10 years
3. evidence of clinical disability progression in the 2 years prior to Screening
4. disability status at Screening
* EDSS score of 3.5-6.0 inclusive
* pyramidal functional system score of 2 or more
* 25'TWT less than 30 seconds
Extension study Inclusion criteria
* Patients initially randomized to fingolimod 1.25 mg or placebo as part of the first study cohort, were to have completed at least 3 years on study drug treatment at the time of extension study initiation.
* Patients initially randomized to fingolimod 0.5 mg or placebo as part of the second study cohort, were to have continued on study drug treatment until such time as the last ongoing patient enrolled in the study had reached 3 years in study
Query!
Minimum age
25
Years
Query!
Query!
Maximum age
65
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
PPMS specific:
* History of relapses/attacks
* Progressive neurological disorder other than PPMS
* Pure cerebellar syndrome or pure visual progressive syndrome or pure
* cognitive progressive syndrome
* Presence of spinal cord compression at screening MRI
* Relevant history of vitamin B12 deficit
* Evidence of syphilis or borreliosis at Screening
Cardiovascular conditions:
* Myocardial infarction within the past 6 months or current unstable ischemic heart disease
* History of angina pectoris due to coronary spasm or history of Raynaud's phenomenon
* Severe cardiac failure or cardiac arrest
* History of symptomatic bradycardia
* Resting pulse <55 bpm pre-dose
* History of sick sinus syndrome or sino-atrial heart block
* History or presence of second and third degree AV block or an increase QT interval (QTc>440 ms)
* Arrythmia requiring treatment with class III antiarrythmic drugs
* History of positive tilt test from workout of vasovagal syncope
* Hypertension, not controlled with medication
Pulmonary:
* Severe respiratory disease or pulmonary fibrosis
* TB
* Abnormal X-ray, suggestive of active pulmonary disease
* Abnormal PFT: <70% of predicted for FEV1 and FVC; <60% for DLCO
* Patients receiving chronic (daily) therapies for asthma
Hepatic:
* Known history of alcohol abuse, chronic liver or biliary disease
* Total or conjugated Brb >ULN, unless in context of Gilbert's syndrome
* AP >1.5xULN; ALT/AST >2xULN; GGT>3xULN
Other:
* History of chronic disease of the immune system other than MS
* Malignancy (other than successfully treated SCC or BCC)
* Diabetes Mellitus
* Macular Edema present at screening
* HIV, Hepatitis C or B, other active infection
* History of total lymphoid irradiation or bone marrow transplantation
* Serum creatinine >1.7 mg/dl
* WBC <3500 cells/mm3
* Lymphocyte count <800 cells/mm3
* History of substance abuse or any other factor that may interfere with subject ability to cooperate and comply with the study procedures
* Unable to undergo MRI scans
* Participation in any therapeutical clinical research study in the 6 months prior to randomization
* Pregnant or lactating women
* Drugs requiring wash-out period:
3 months:
* Systemic corticosteroids or ACTH
* INF-beta
6 months:
* Immunosuppressive medication
* Immunoglobulins
* Monoclonal antibodies
* Drugs that exclude participation in the study:
* Cladribine
* Cyclophosphamide
* Mitoxantrone (except: patients who received a cumulative dose of no more than 60mg/m2 more than 5 years ago could enter the study)
Extension study Exclusion criteria
-Patients were not eligible for enrollment in the extension study if they had any of the following key exclusion criteria at the extension study Baseline visit: active chronic immune system disease other than MS (or stable disease treated with immune therapy); known immunodeficiency syndrome; active infection; uncontrolled diabetes mellitus; macularedema; treatment with Class Ia or III antiarrhythmic drugs; any of the specified cardiac, pulmonary, or hepatic conditions; or any medically unstable condition
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Stopped early
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
28/07/2008
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
22/06/2015
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
970
Query!
Recruitment in Australia
Recruitment state(s)
NSW,TAS,VIC
Query!
Recruitment hospital [1]
0
0
Novartis Investigative Site - Camperdown
Query!
Recruitment hospital [2]
0
0
Novartis Investigative Site - Liverpool
Query!
Recruitment hospital [3]
0
0
Novartis Investigative Site - Hobart
Query!
Recruitment hospital [4]
0
0
Novartis Investigative Site - Box Hill
Query!
Recruitment hospital [5]
0
0
Novartis Investigative Site - Heidelberg
Query!
Recruitment hospital [6]
0
0
Novartis Investigative Site - Parkville
Query!
Recruitment postcode(s) [1]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [2]
0
0
2170 - Liverpool
Query!
Recruitment postcode(s) [3]
0
0
7000 - Hobart
Query!
Recruitment postcode(s) [4]
0
0
3128 - Box Hill
Query!
Recruitment postcode(s) [5]
0
0
3084 - Heidelberg
Query!
Recruitment postcode(s) [6]
0
0
3050 - Parkville
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Colorado
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Georgia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Illinois
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Kansas
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Maryland
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Massachusetts
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Michigan
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Missouri
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
New Jersey
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
New York
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
North Carolina
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Ohio
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Pennsylvania
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Tennessee
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Texas
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Vermont
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Virginia
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Washington
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Wisconsin
Query!
Country [22]
0
0
Belgium
Query!
State/province [22]
0
0
Charleroi
Query!
Country [23]
0
0
Belgium
Query!
State/province [23]
0
0
Edegem
Query!
Country [24]
0
0
Belgium
Query!
State/province [24]
0
0
Leuven
Query!
Country [25]
0
0
Belgium
Query!
State/province [25]
0
0
Liege
Query!
Country [26]
0
0
Belgium
Query!
State/province [26]
0
0
Melsbroek
Query!
Country [27]
0
0
Belgium
Query!
State/province [27]
0
0
Sint-Truiden
Query!
Country [28]
0
0
Canada
Query!
State/province [28]
0
0
Alberta
Query!
Country [29]
0
0
Canada
Query!
State/province [29]
0
0
British Columbia
Query!
Country [30]
0
0
Canada
Query!
State/province [30]
0
0
Nova Scotia
Query!
Country [31]
0
0
Canada
Query!
State/province [31]
0
0
Ontario
Query!
Country [32]
0
0
Canada
Query!
State/province [32]
0
0
Quebec
Query!
Country [33]
0
0
Canada
Query!
State/province [33]
0
0
Saskatchewan
Query!
Country [34]
0
0
Czechia
Query!
State/province [34]
0
0
Czech Republic
Query!
Country [35]
0
0
Czechia
Query!
State/province [35]
0
0
CZE
Query!
Country [36]
0
0
Czechia
Query!
State/province [36]
0
0
Ostrava-Poruba
Query!
Country [37]
0
0
Czechia
Query!
State/province [37]
0
0
Plzen
Query!
Country [38]
0
0
Czechia
Query!
State/province [38]
0
0
Praha 2
Query!
Country [39]
0
0
Czechia
Query!
State/province [39]
0
0
Teplice
Query!
Country [40]
0
0
Denmark
Query!
State/province [40]
0
0
Aarhus
Query!
Country [41]
0
0
Denmark
Query!
State/province [41]
0
0
Sønderborg
Query!
Country [42]
0
0
Finland
Query!
State/province [42]
0
0
Helsinki
Query!
Country [43]
0
0
Finland
Query!
State/province [43]
0
0
Tampere
Query!
Country [44]
0
0
Finland
Query!
State/province [44]
0
0
Turku
Query!
Country [45]
0
0
France
Query!
State/province [45]
0
0
Bordeaux Cedex
Query!
Country [46]
0
0
France
Query!
State/province [46]
0
0
Lille Cedex
Query!
Country [47]
0
0
France
Query!
State/province [47]
0
0
Marseille cedex 05
Query!
Country [48]
0
0
France
Query!
State/province [48]
0
0
Montpellier
Query!
Country [49]
0
0
France
Query!
State/province [49]
0
0
Nantes Cedex 1
Query!
Country [50]
0
0
France
Query!
State/province [50]
0
0
Paris Cedex 13
Query!
Country [51]
0
0
France
Query!
State/province [51]
0
0
Rennes
Query!
Country [52]
0
0
France
Query!
State/province [52]
0
0
Strasbourg
Query!
Country [53]
0
0
Germany
Query!
State/province [53]
0
0
Berlin
Query!
Country [54]
0
0
Germany
Query!
State/province [54]
0
0
Bochum
Query!
Country [55]
0
0
Germany
Query!
State/province [55]
0
0
Dresden
Query!
Country [56]
0
0
Germany
Query!
State/province [56]
0
0
Duesseldorf
Query!
Country [57]
0
0
Germany
Query!
State/province [57]
0
0
Erlangen
Query!
Country [58]
0
0
Germany
Query!
State/province [58]
0
0
Essen
Query!
Country [59]
0
0
Germany
Query!
State/province [59]
0
0
Freiburg
Query!
Country [60]
0
0
Germany
Query!
State/province [60]
0
0
Hannover
Query!
Country [61]
0
0
Germany
Query!
State/province [61]
0
0
Hennigsdorf
Query!
Country [62]
0
0
Germany
Query!
State/province [62]
0
0
Magdeburg
Query!
Country [63]
0
0
Germany
Query!
State/province [63]
0
0
Muenchen
Query!
Country [64]
0
0
Germany
Query!
State/province [64]
0
0
Muenster
Query!
Country [65]
0
0
Germany
Query!
State/province [65]
0
0
Munchen
Query!
Country [66]
0
0
Germany
Query!
State/province [66]
0
0
Teupitz
Query!
Country [67]
0
0
Germany
Query!
State/province [67]
0
0
Trier
Query!
Country [68]
0
0
Germany
Query!
State/province [68]
0
0
Würzburg
Query!
Country [69]
0
0
Hungary
Query!
State/province [69]
0
0
Budapest
Query!
Country [70]
0
0
Hungary
Query!
State/province [70]
0
0
Debrecen
Query!
Country [71]
0
0
Hungary
Query!
State/province [71]
0
0
Gyor
Query!
Country [72]
0
0
Hungary
Query!
State/province [72]
0
0
Miskolc
Query!
Country [73]
0
0
Hungary
Query!
State/province [73]
0
0
Veszprem
Query!
Country [74]
0
0
Italy
Query!
State/province [74]
0
0
BA
Query!
Country [75]
0
0
Italy
Query!
State/province [75]
0
0
BS
Query!
Country [76]
0
0
Italy
Query!
State/province [76]
0
0
CH
Query!
Country [77]
0
0
Italy
Query!
State/province [77]
0
0
CT
Query!
Country [78]
0
0
Italy
Query!
State/province [78]
0
0
GE
Query!
Country [79]
0
0
Italy
Query!
State/province [79]
0
0
MI
Query!
Country [80]
0
0
Italy
Query!
State/province [80]
0
0
PA
Query!
Country [81]
0
0
Italy
Query!
State/province [81]
0
0
PD
Query!
Country [82]
0
0
Italy
Query!
State/province [82]
0
0
RM
Query!
Country [83]
0
0
Italy
Query!
State/province [83]
0
0
TO
Query!
Country [84]
0
0
Italy
Query!
State/province [84]
0
0
VA
Query!
Country [85]
0
0
Netherlands
Query!
State/province [85]
0
0
CK
Query!
Country [86]
0
0
Netherlands
Query!
State/province [86]
0
0
Amsterdam
Query!
Country [87]
0
0
Netherlands
Query!
State/province [87]
0
0
Eindhoven
Query!
Country [88]
0
0
Netherlands
Query!
State/province [88]
0
0
Nieuwegein
Query!
Country [89]
0
0
Netherlands
Query!
State/province [89]
0
0
Nijmegen
Query!
Country [90]
0
0
Netherlands
Query!
State/province [90]
0
0
Sittard-Geleen
Query!
Country [91]
0
0
Poland
Query!
State/province [91]
0
0
Lodz
Query!
Country [92]
0
0
Poland
Query!
State/province [92]
0
0
Lublin
Query!
Country [93]
0
0
Poland
Query!
State/province [93]
0
0
Warszawa
Query!
Country [94]
0
0
Spain
Query!
State/province [94]
0
0
Andalucia
Query!
Country [95]
0
0
Spain
Query!
State/province [95]
0
0
Catalunya
Query!
Country [96]
0
0
Spain
Query!
State/province [96]
0
0
Comunidad Valenciana
Query!
Country [97]
0
0
Spain
Query!
State/province [97]
0
0
Madrid
Query!
Country [98]
0
0
Spain
Query!
State/province [98]
0
0
Pais Vasco
Query!
Country [99]
0
0
Sweden
Query!
State/province [99]
0
0
Goeteborg
Query!
Country [100]
0
0
Sweden
Query!
State/province [100]
0
0
Stockholm
Query!
Country [101]
0
0
Switzerland
Query!
State/province [101]
0
0
Basel
Query!
Country [102]
0
0
Switzerland
Query!
State/province [102]
0
0
Bern
Query!
Country [103]
0
0
Switzerland
Query!
State/province [103]
0
0
Lausanne
Query!
Country [104]
0
0
Switzerland
Query!
State/province [104]
0
0
Lugano
Query!
Country [105]
0
0
Switzerland
Query!
State/province [105]
0
0
Zuerich
Query!
Country [106]
0
0
Turkey
Query!
State/province [106]
0
0
Ankara
Query!
Country [107]
0
0
Turkey
Query!
State/province [107]
0
0
Atakum / Samsun
Query!
Country [108]
0
0
Turkey
Query!
State/province [108]
0
0
Balcova / Izmir
Query!
Country [109]
0
0
Turkey
Query!
State/province [109]
0
0
Istanbul
Query!
Country [110]
0
0
Turkey
Query!
State/province [110]
0
0
Yenisehir / Izmir
Query!
Country [111]
0
0
United Kingdom
Query!
State/province [111]
0
0
Manchester
Query!
Country [112]
0
0
United Kingdom
Query!
State/province [112]
0
0
South Yorkshire
Query!
Country [113]
0
0
United Kingdom
Query!
State/province [113]
0
0
Bristol
Query!
Country [114]
0
0
United Kingdom
Query!
State/province [114]
0
0
London
Query!
Country [115]
0
0
United Kingdom
Query!
State/province [115]
0
0
Newcastle Upon Tyne
Query!
Country [116]
0
0
United Kingdom
Query!
State/province [116]
0
0
Norwich
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Novartis Pharmaceuticals
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study is to evaluate whether FTY720 is effective in delaying MS disability progression compared to placebo in patients with PPMS. This was an open-label, single-arm extension study to a double-blind, randomized multicenter, placebo-controlled, parallel-group core study. The core study completed and eligible patients enrolled into the extension study at the next scheduled or unscheduled core study visit. All patients, regardless of their treatment in the core study, received fingolimod 0.5 mg in the extension study. The extension study was terminated early after the results of the core study became available showing that the study did not meet its primary endpoint which was defined as confirmed disability progression in this population
Query!
Trial website
https://clinicaltrials.gov/study/NCT00731692
Query!
Trial related presentations / publications
Leppert D, Kropshofer H, Haring DA, Dahlke F, Patil A, Meinert R, Tomic D, Kappos L, Kuhle J. Blood Neurofilament Light in Progressive Multiple Sclerosis: Post Hoc Analysis of 2 Randomized Controlled Trials. Neurology. 2022 May 24;98(21):e2120-e2131. doi: 10.1212/WNL.0000000000200258. Epub 2022 Apr 4. Koch MW, Mostert J, Repovic P, Bowen JD, Strijbis E, Uitdehaag B, Cutter G. Smoking, obesity, and disability worsening in PPMS: an analysis of the INFORMS original trial dataset. J Neurol. 2022 Mar;269(3):1663-1669. doi: 10.1007/s00415-021-10750-z. Epub 2021 Aug 15. Koch MW, Mostert J, Zhang Y, Wolinsky JS, Lublin FD, Strijbis E, Cutter G. Association of Age With Contrast-Enhancing Lesions Across the Multiple Sclerosis Disease Spectrum. Neurology. 2021 Sep 28;97(13):e1334-e1342. doi: 10.1212/WNL.0000000000012603. Epub 2021 Aug 10. Miller DH, Lublin FD, Sormani MP, Kappos L, Yaldizli O, Freedman MS, Cree BAC, Weiner HL, Lubetzki C, Hartung HP, Montalban X, Uitdehaag BMJ, MacManus DG, Yousry TA, Gandini Wheeler-Kingshott CAM, Li B, Putzki N, Merschhemke M, Haring DA, Wolinsky JS. Brain atrophy and disability worsening in primary progressive multiple sclerosis: insights from the INFORMS study. Ann Clin Transl Neurol. 2018 Jan 30;5(3):346-356. doi: 10.1002/acn3.534. eCollection 2018 Mar. Lublin F, Miller DH, Freedman MS, Cree BAC, Wolinsky JS, Weiner H, Lubetzki C, Hartung HP, Montalban X, Uitdehaag BMJ, Merschhemke M, Li B, Putzki N, Liu FC, Haring DA, Kappos L; INFORMS study investigators. Oral fingolimod in primary progressive multiple sclerosis (INFORMS): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet. 2016 Mar 12;387(10023):1075-1084. doi: 10.1016/S0140-6736(15)01314-8. Epub 2016 Jan 28. Erratum In: Lancet. 2017 Jan 21;389(10066):254. doi: 10.1016/S0140-6736(17)30042-9. Hartung HP, Aktas O. Bleak prospects for primary progressive multiple sclerosis therapy: downs and downs, but a glimmer of hope. Ann Neurol. 2009 Oct;66(4):429-32. doi: 10.1002/ana.21880. No abstract available.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Novartis Pharmaceuticals
Query!
Address
0
0
Novartis Pharmaceuticals
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
Query!
No/undecided IPD sharing reason/comment
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
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00731692