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
ClinicalTrials.gov Identifier:
NCT00368251
First received: August 23, 2006
Last updated: August 26, 2014
Last verified: May 2013

August 23, 2006
August 26, 2014
November 2006
January 2008   (final data collection date for primary outcome measure)
Percent change from Baseline on the Action Myoclonus Score (Unified Myoclonus Rating Scale (UMRS) Section 4) [ Time Frame: From Baseline to end of Treatment Period (week 14 or Early Discontinuation Visit) ] [ Designated as safety issue: No ]
The range for Action Myoclonus Score (centrally read) is 0 (best) - 160 (worst). Percent change from Baseline = 100 X ((Baseline UMRS4 - Treatment UMRS4) / Baseline UMRS4). Baseline is defined as the last non-missing value prior or on Randomization Visit.
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 NCT00368251 on ClinicalTrials.gov Archive Site
  • Percent change from Baseline on the Functional Disability Score (Unified Myoclonus Rating Scale (UMRS) Section 5) [ Time Frame: Baseline to end of Treatment Period (week 14 or Early Discontinuation Visit) ] [ Designated as safety issue: No ]
    The range for Functional Disability Score is 0 (best) to 28 (worst). Percent change from Baseline = 100 X ((Baseline UMRS5 - Treatment UMRS5) / Baseline UMRS5). Baseline is defined as the last non-missing value prior or on Randomization Visit.
  • Percent change from Baseline on the Stimulus Sensitivity Score (Unified Myoclonus Rating Scale (UMRS) Section 3) [ Time Frame: Baseline to end of Treatment Period (week 14 or Early Discontinuation Visit) ] [ Designated as safety issue: No ]
    The range for Stimulus Sensitivity Score is 0 (best) to 17 (worst). Percent change from Baseline = 100 X ((Baseline UMRS3 - Treatment UMRS3) / Baseline UMRS3). Baseline is defined as the last non-missing value prior or on Randomization Visit.
  • Percent change from Baseline on the Myoclonus Patient Questionnaire (Unified Myoclonus Rating Scale (UMRS) Section 1) [ Time Frame: Baseline to end of Treatment Period (week 14 or Early Discontinuation Visit) ] [ Designated as safety issue: No ]
    The range for Myoclonus Patient Questionnaire is 0 (best) to44 (worst). Percent change from Baseline = 100 X ((Baseline UMRS1 - Treatment UMRS1) / Baseline UMRS1). Baseline is defined as the last non-missing value prior or on Randomization Visit.
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 Multicenter, 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 With Genetically Ascertained ULD

The study will compare the efficacy and safety of Brivaracetam with placebo in patients with Unverricht-Lundborg Disease (ULD).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Unverricht-Lundborg Disease
  • Drug: Brivaracetam
    5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up-Titration Period)
    Other Name: ucb34714
  • Drug: Brivaracetam
    150 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
  • Other: Placebo
    Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
  • Experimental: Brivaracetam 5 mg/day
    Brivaracetam (BRV) 5 mg/day
    Intervention: Drug: Brivaracetam
  • Experimental: Brivaracetam 150 mg/day
    Brivaracetam (BRV) 150 mg/day
    Intervention: Drug: Brivaracetam
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
January 2008
January 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects with diagnosed Unverricht-Lundborg Disease (ULD) ascertained by appropriate genetic testing

Exclusion Criteria:

  • Patients who never received adequate treatment before, i.e. with Valproic Acid (VPA) or Clonazepam (CZP)
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Finland,   France,   United States,   Russian Federation,   Canada,   Serbia,   Israel,   Tunisia
 
NCT00368251
N01236, RPCE06C2320, 2006-001536-46
No
UCB Pharma
UCB Pharma
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB Pharma
May 2013

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