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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Pharma SA )
ClinicalTrials.gov Identifier:
NCT00357669
First received: July 25, 2006
Last updated: May 15, 2015
Last verified: May 2015

July 25, 2006
May 15, 2015
November 2006
October 2007   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT00357669 on ClinicalTrials.gov Archive Site
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
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.
Not Provided
Not Provided
 
Brivaracetam as add-on Treatment of Unverricht-Lundborg Disease in Adolescents and Adults
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
The study will compare the efficacy and safety of brivaracetam with placebo in patients with Unverricht-Lundborg disease.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Unverricht-Lundborg Disease
  • 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
  • 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
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.
 
Completed
50
October 2007
October 2007   (final data collection date for primary outcome measure)

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
Both
16 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Finland,   France,   Italy,   Netherlands,   Réunion,   Sweden,   Tunisia
 
NCT00357669
N01187, 2006-000169-12
No
Not Provided
Not Provided
UCB Pharma SA
UCB Pharma SA
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB Pharma
May 2015

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