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Trial record 11 of 19 for:    "Myoclonus epilepsy"

Brivaracetam as add-on Treatment of Unverricht-Lundborg Disease in Adolescents and Adults

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ClinicalTrials.gov Identifier: NCT00357669
Recruitment Status : Completed
First Posted : July 27, 2006
Last Update Posted : May 18, 2015
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Pharma SA )

Tracking Information
First Submitted Date  ICMJE July 25, 2006
First Posted Date  ICMJE July 27, 2006
Last Update Posted Date May 18, 2015
Study Start Date  ICMJE November 2006
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2015)
Percent reduction from baseline on the Action Myoclonus score (Unified Myoclonus Rating Scale (UMRS) Section 4) at the end of the Treatment Period [ Time Frame: End of treatment period (Week 14 or early discontinuation visit) ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 25, 2006)
Efficacy of BRV on the symptom relief of myoclonus. The change in scores of action myoclonus (Section 4) of the Unified Myoclonus Rating Scale at 4, 8 and 14 weeks.
Change History Complete list of historical versions of study NCT00357669 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2015)
  • Percent reduction from baseline on the functional disability score (UMRS Section 5) at the end of the Treatment Period [ Time Frame: End of treatment period (week 14 or early discontinuation visit) ]
  • Percent reduction from baseline on the stimulus sensitivity score (UMRS Section 3) at the end of the Treatment Period [ Time Frame: End of treatment period (week 14 or early discontinuation visit) ]
  • Percent reduction from baseline on the myoclonus patient questionnaire (UMRS Section 1) at the end of the Treatment Period [ Time Frame: End of treatment period (week 14 or early discontinuation visit) ]
  • Global Evaluation Scale by Investigator (I-GES) at the end of the Treatment Period [ Time Frame: End of treatment period (week 14 or early discontinuation visit) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2006)
The scores on sections 1 (Myoclonus Patient Questionnaire), 3 (Stimulus sensitivity) and 5 (Functional disability test) of the Unified Myoclonus Rating Scale at 4, 8 and 14 weeks.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Brivaracetam as add-on Treatment of Unverricht-Lundborg Disease in Adolescents and Adults
Official Title  ICMJE A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Efficacy and Safety of Brivaracetam Used as Adjunctive Treatment for 12 Weeks in Adolescent and Adult Patients (≥16 Years) With Genetically Ascertained Unverricht-Lundborg Disease
Brief Summary The study will compare the efficacy and safety of brivaracetam with placebo in patients with Unverricht-Lundborg disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Unverricht-Lundborg Disease
Intervention  ICMJE
  • Drug: Brivaracetam 25 mg
    • Active Substance: Brivaracetam
    • Pharmaceutical Form: Tablet
    • Concentration: 25 mg
    • Route of Administration: Oral use
    Other Name: ucb34714
  • Drug: Brivaracetam 50 mg
    • Active Substance: Brivaracetam
    • Pharmaceutical Form: Tablet
    • Concentration: 50 mg
    • Route of Administration: Oral use
    Other Name: ucb34714
  • Other: Placebo
    • Active Substance: Placebo Pharmaceutical Form: Tablet
    • Concentration: 25 mg and 50 mg
    • Route of Administration: Oral use
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
  • Experimental: Brivaracetam 50 mg/day
    BRV 50 mg/day
    Interventions:
    • Drug: Brivaracetam 25 mg
    • Drug: Brivaracetam 50 mg
  • Experimental: Brivaracetam 150 mg/day
    BRV 150 mg/day
    Interventions:
    • Drug: Brivaracetam 25 mg
    • Drug: Brivaracetam 50 mg
Publications * Kälviäinen R, Genton P, Andermann E, Andermann F, Magaudda A, Frucht SJ, Schlit AF, Gerard D, de la Loge C, von Rosenstiel P. Brivaracetam in Unverricht-Lundborg disease (EPM1): Results from two randomized, double-blind, placebo-controlled studies. Epilepsia. 2016 Feb;57(2):210-21. doi: 10.1111/epi.13275. Epub 2015 Dec 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 1, 2007)
50
Original Enrollment  ICMJE
 (submitted: July 25, 2006)
42
Actual Study Completion Date  ICMJE October 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects with diagnosed Unverricht-Lundborg disease (ULD) ascertained by appropriate genetic testing for a homozygous or compound heterozygous mutation in the Cystatin B (CSTB) gene
  • Subjects with moderate to severe myoclonus documented by an Action Myoclonus sum score of ≥ 30 (evaluation by investigator)
  • Subjects currently being or having been treated with clonazepam up to the maximum recommended daily dose of 20 mg or up to their individual optimal dose as assessed by the investigator
  • Subjects currently being or having been treated with valproate up to the maximum recommended daily dose 60 mg/kg or serum levels of 100 mcg/ml or up to their individual optimal dose as specified by the investigator

Exclusion Criteria:

  • Subjects currently on felbamate or having been on felbamate within less than 18 months prior to Visit 1
  • Subjects currently treated with phenytoin or having been on phenytoin in the last month prior to Visit 1
  • Subjects currently on vigabatrine. Subjects having been on vigabatrine if no visual fields examination report available including standard static (Humphrey or Octopus) or cinetic perimetry (Goldman)
  • Subject taking any drug with possible central nervous system (CNS) effects
  • Subjects taking any drug that may significantly influence the metabolism of BRV (CYP2C or CYP3A potent inducers/inhibitors)
  • Known clinically significant acute or chronic illness or illness which may impair reliable participation in the trial, necessitate the use of medication not allowed by protocol or represent a safety risk in the Investigator's opinion
  • Subjects with history of severe adverse hematological reaction to any drug
  • Impaired hepatic function: ALAT/SGPT, ASAT/SGOT, alkaline phosphatase, GGT value of more than three times the upper limit of the reference range
  • History of suicide attempt during the last 5 years
  • Subject with suicidal ideations within the last year or at risk of suicide attempt unless cleared by written confirmation from a psychiatrist and approved by the UCB physician
  • Ongoing psychiatric disorder other than mild controlled disorder
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland,   France,   Italy,   Netherlands,   Réunion,   Sweden,   Tunisia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00357669
Other Study ID Numbers  ICMJE N01187
2006-000169-12 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma ( UCB Pharma SA )
Study Sponsor  ICMJE UCB Pharma SA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
PRS Account UCB Pharma
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP