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

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


Condition Intervention Phase
Unverricht-Lundborg Disease
Drug: Brivaracetam
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 56
Study Start Date: November 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Other: Placebo
Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
Experimental: Brivaracetam 5 mg/day
Brivaracetam (BRV) 5 mg/day
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
Experimental: Brivaracetam 150 mg/day
Brivaracetam (BRV) 150 mg/day
Drug: Brivaracetam
150 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368251

Locations
United States, California
135
San Francisco, California, United States
United States, Florida
133
Gainesville, Florida, United States
United States, New York
132
New York, New York, United States
United States, Virginia
131
Charlottesville, Virginia, United States
Canada, British Columbia
151
Vancouver, British Columbia, Canada
Canada, Quebec
150
Montreal, Quebec, Canada
Canada
152
Quebec, Canada
Finland
100
Helsinki, Finland
France
122
Bron, France
121
Lille, France
120
Paris, France
Israel
170
Tel Aviv, Israel
Russian Federation
141
Moscow, Russian Federation
143
Samara, Russian Federation
142
St. Petersburg, Russian Federation
Serbia
161
Belgrade, Serbia
162
Belgrade, Serbia
Tunisia
180
La Manouba, Tunisia
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00368251     History of Changes
Other Study ID Numbers: N01236, RPCE06C2320, 2006-001536-46
Study First Received: August 23, 2006
Last Updated: August 26, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
European Union: European Medicines Agency

Keywords provided by UCB Pharma:
Unverricht-Lundborg Disease
Baltic Myoclonus
Progressive Myoclonic Epilepsies
Myoclonus
Brivaracetam

Additional relevant MeSH terms:
Unverricht-Lundborg Syndrome
Brain Diseases
Central Nervous System Diseases
Epilepsies, Myoclonic
Epilepsy
Genetic Diseases, Inborn
Heredodegenerative Disorders, Nervous System
Myoclonic Epilepsies, Progressive
Nervous System Diseases
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on November 27, 2014