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

Sponsor:	UCB, Inc.
Collaborator:	no collaborators
Information provided by:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00357669

Purpose

The study will compare the efficacy and safety of brivaracetam with placebo in patients with Unverricht-Lundborg disease.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
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:

Drug Information available for: Brivaracetam

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	50
Study Start Date:	November 2006
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo: Placebo Comparator	Other: Placebo Placebo bid, 14 weeks (2 week up-titration period + 12 week maintenance period)
Brivaracetam 50mg/day: Experimental BRV 50mg/day	Drug: Brivaracetam 25mg tablet, 50mg bid, 12 weeks (after 2 week up-titration period)
Brivaracetam 150mg/day: Experimental BRV 150mg/day	Drug: Brivaracetam 25 and 50mg tablets, 150 mg bid, 12 weeks (after 2 week up-titration period)

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00357669

Locations

Sponsors and Collaborators

UCB, Inc.

no collaborators

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

No publications provided

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	N01187, RPCE06C2321
Study First Received:	July 25, 2006
Last Updated:	August 4, 2009
ClinicalTrials.gov Identifier:	NCT00357669 History of Changes
Health Authority:	European Union: European Medicines Agency

Keywords provided by UCB, Inc.:

Unverricht-Lundborg disease
Baltic myoclonus
progressive myoclonic epilepsies
myoclonus
brivaracetam

Additional relevant MeSH terms:

Epilepsies, Myoclonic
Unverricht-Lundborg Syndrome
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Epilepsy

Nervous System Diseases
Central Nervous System Diseases
Myoclonic Epilepsies, Progressive
Neurodegenerative Diseases
Brain Diseases

ClinicalTrials.gov processed this record on November 30, 2009