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

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:

Genetics Home Reference related topics: PRICKLE1-related progressive myoclonus epilepsy with ataxia pyridoxal 5'-phosphate-dependent epilepsy Unverricht-Lundborg disease

MedlinePlus related topics: Epilepsy

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

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

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, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

No publications provided

Responsible Party:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00368251 History of Changes
Other Study ID Numbers:	N01236, RPCE06C2320
Study First Received:	August 23, 2006
Last Updated:	May 13, 2013
Health Authority:	United States: Food and Drug Administration Canada: Health Canada European Union: European Medicines Agency

Keywords provided by UCB, Inc.:

Unverricht-Lundborg Disease
Baltic Myoclonus
Progressive Myoclonic Epilepsies
Myoclonus
Brivaracetam

Additional relevant MeSH terms:

Unverricht-Lundborg Syndrome
Myoclonic Epilepsies, Progressive
Epilepsies, Myoclonic
Epilepsy
Brain Diseases

Central Nervous System Diseases
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on June 18, 2013