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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:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00357669
First received: July 25, 2006
Last updated: August 4, 2009
Last verified: August 2009
History of Changes

July 25, 2006
August 4, 2009
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) [ 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) [ 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) [ 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) [ 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 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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Unverricht-Lundborg Disease
  • Drug: Brivaracetam
    25mg tablet, 50mg bid, 12 weeks (after 2 week up-titration period)
    Other Name: ucb34714
  • Drug: Brivaracetam
    25 and 50mg tablets, 150 mg bid, 12 weeks (after 2 week up-titration period)
    Other Name: ucb34714
  • Other: Placebo
    Placebo bid, 14 weeks (2 week up-titration period + 12 week maintenance period)
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
  • Experimental: Brivaracetam 50mg/day
    BRV 50mg/day
    Intervention: Drug: Brivaracetam
  • Experimental: Brivaracetam 150mg/day
    BRV 150mg/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
50
October 2007
October 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects with diagnosed ULD ascertained by appropriate genetic testing.

Exclusion Criteria:

  • Patients who never received adequate treatment before, i.e. with VPA or CZP
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Finland,   France,   Italy,   Netherlands,   Réunion,   Sweden,   Tunisia
 
NCT00357669
N01187, RPCE06C2321
Not Provided
Study Director, UCB
UCB, Inc.
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB, Inc.
August 2009

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