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

Tracking Information

First Received Date ^ICMJE

August 23, 2006

Last Updated Date

August 11, 2009

Start Date ^ICMJE

November 2006

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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.

Change History

Complete list of historical versions of study NCT00368251 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Unverricht-Lundborg Disease

Intervention ^ICMJE

Drug: Brivaracetam
Other: Placebo

Study Arms / Comparison Groups

Experimental: BRV 5mg/day
Experimental: BRV 150mg/day

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2008

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada, Finland, France, Israel, Russian Federation, Serbia

Administrative Information

NCT ID ^ICMJE

NCT00368251

Responsible Party

UCB Clinical Trial Call Center, UCB

Study ID Numbers ^ICMJE

N01236, RPCE06C2320

Study Sponsor ^ICMJE

UCB, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

Information Provided By

UCB, Inc.

Verification Date

August 2009

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