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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02582866
Registration number
NCT02582866
Ethics application status
Date submitted
20/10/2015
Date registered
21/10/2015
Date last updated
6/06/2023
Titles & IDs
Public title
A Clinical Study to Investigate the Long-term Use of Lacosamide as Monotherapy in Subjects Who Completed Study SP0994
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Scientific title
A Multicenter, Open-label, Follow-up Study to Assess the Long-term Use of Lacosamide (Flexible Dose From 200 to 600 mg/Day) Used as Monotherapy in Subjects Who Completed SP0994 and Received Lacosamide Monotherapy Treatment
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Secondary ID [1]
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2015-001549-96
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Secondary ID [2]
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SP1042
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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:
Epilepsy
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Condition category
Condition code
Neurological
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Epilepsy
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Lacosamide
Experimental: Lacosamide - Lacosamide (LCM) will be administered orally twice daily from 200 mg/day to 600 mg/day (at approximately 12 hour intervals in the morning and in the evening) in 2 divided doses. Medication must not be chewed and must be swallowed with a sufficient amount of fluid. The investigator may maintain the subject's LCM dose, decrease the dose in decrements of 100 mg/day per week to a minimum dose of LCM 200 mg/day, or increase the dose in increments of 100 mg/day per week up to a maximum dose of LCM 600 mg/day.
Subjects stopping LCM should be tapered off LCM at recommended decreasing steps of 200 mg/day/week. A slower taper (eg, 100 mg/day/week) or faster taper is permitted, if medically necessary; however, the maximum duration of tapering should not exceed 6 weeks.
Treatment: Drugs: Lacosamide
Pharmaceutical Form: Oral tablets
Concentration: 50 mg
Route of Administration: Oral administration
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Intervention code [1]
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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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Percentage of Participants Experiencing Any Adverse Events (AEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator
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Assessment method [1]
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An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication.
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Timepoint [1]
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From Visit 1 (Week 0) to Final Visit (up to Week 158)
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Primary outcome [2]
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Percentage of Participants That Withdrew Due to Adverse Events (AEs)
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Assessment method [2]
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An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication.
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Timepoint [2]
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From Visit 1 (Week 0) to Final Visit (up to Week 158)
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Primary outcome [3]
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Percentage of Participants Experiencing Any Serious Adverse Events (SAEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator
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Assessment method [3]
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A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:
Results in death
Is life-threatening
Requires in patient hospitalization or prolongation of existing hospitalization
Is a congenital anomaly or birth defect
Is an infection that requires treatment parenteral antibiotics
Other important medical events which based on medical or scientific judgement may jeopardize the study participants, or may require medical or surgical intervention to prevent any of the above.
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Timepoint [3]
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From Visit 1 (Week 0) to Final Visit (up to Week 158)
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Eligibility
Key inclusion criteria
- An Institutional Review Board /Institutional Ethics Committee approved written
Informed Consent Form (ICF) is signed and dated by the subject or by the parent(s) or
legal representative. The ICF or a specific Assent form, where required, will be
signed and dated by minors
- Subject/legal representative is considered reliable and capable of adhering to the
protocol, visit schedule, and medication intake according to the judgment of the
investigator
- Subject has completed the Termination Visit of SP0994 [NCT01465997] and has been
treated with lacosamide monotherapy
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Minimum age
17
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
- Subject is receiving any investigational drugs or using any experimental devices in
addition to lacosamide (LCM)
- Subject experienced a seizure at the 3rd target dose (i.e. LCM 600 mg/day) during
SP0994
- Subject required another Anti Epileptic Drug (AED) for the treatment of seizures
- Subject meets a "must" withdrawal criteria for SP0994
- Subject is experiencing an ongoing Serious Adverse Event from SP0994
- Female subject who is pregnant or nursing, and/or a woman of childbearing potential
who is not surgically sterile, 2 year postmenopausal or does not practice one highly
effective method of contraception, unless sexually abstinent, for the duration of the
study
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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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
1/01/2016
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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
1/01/2020
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Sample size
Target
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Accrual to date
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Final
106
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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Bulgaria
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Blagoevgrad
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Bulgaria
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Pazardzhik
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Bulgaria
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Sofia
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Finland
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Helsinki
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Finland
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Kuopio
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France
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Nancy
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Germany
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Altenburg
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Germany
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Bad Neustadt An Der Saale
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Germany
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Leipzig
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Germany
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Marburg
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Germany
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Osnabruck
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Japan
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Asaka
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Japan
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Kagoshima
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Japan
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Kamakura
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Japan
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Nagoyashi
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Japan
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Okayama
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Japan
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Sapporo
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Korea, Republic of
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Daegu
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Korea, Republic of
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Daejeon
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Korea, Republic of
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Seoul
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Latvia
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Riga
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Mexico
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San Luis Potosi
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Philippines
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Pasig
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Quezon
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Poland
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Katowice
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Poland
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Lublin
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Poland
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Warszawa
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Romania
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Bucuresti
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Romania
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Iasi
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Romania
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Targu Mures
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Russian Federation
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Kazan
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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Russian Federation
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Saint Petersburg
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Sweden
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Goteborg
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Sweden
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Linköping
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Sweden
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Stockholm
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Switzerland
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Aarau
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Switzerland
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Biel
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Switzerland
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Lugano
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Ukraine
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Chernihiv
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Ukraine
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Kharkov
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Ukraine
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Odesa
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
UCB Biopharma S.P.R.L.
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Parexel
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Ethics approval
Ethics application status
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Summary
Brief summary
Study is conducted to evaluate the long-term safety and tolerability of lacosamide (LCM) in
patients receiving LCM in SP0994 [NCT01465997]. The study will enable collection of
additional monotherapy safety data, and will facilitate access to treatment until commercial
availability for monotherapy use.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02582866
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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UCB Cares
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Address
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+1 844 599 2273 (UCB)
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02582866
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