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.

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


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind 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

Genetic and Rare Diseases Information Center resources: Myoclonus Epilepsy Progressive Myoclonic Epilepsy Unverricht-Lundborg Disease

U.S. FDA Resources

Further study details as provided by UCB Pharma:

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 Comparator: Placebo	Other: Placebo Placebo bid, 14 weeks (2 week up-titration period + 12 week maintenance period)
Experimental: Brivaracetam 50mg/day BRV 50mg/day	Drug: Brivaracetam 25mg tablet, 50mg bid, 12 weeks (after 2 week up-titration period) Other Name: ucb34714
Experimental: Brivaracetam 150mg/day BRV 150mg/day	Drug: Brivaracetam 25 and 50mg tablets, 150 mg bid, 12 weeks (after 2 week up-titration period) Other Name: ucb34714

Eligibility


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

Criteria

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

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: NCT00357669

Locations


Finland

Kuopio, Finland

Tampere, Finland
France

Marseille, France

Montpellier Cedex 5, France
Italy

Bologna, Italy

Messina, Italy

Milano, Italy

Napoli, Italy
Netherlands

Heemstede, Netherlands

Heeze, Netherlands
Réunion

St Pierre Cedex, Réunion
Sweden

Goteborg, Sweden
Tunisia

Tunis, 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:	Study Director, UCB
ClinicalTrials.gov Identifier:	NCT00357669 History of Changes
Other Study ID Numbers:	N01187, RPCE06C2321, 2006-000169-12
Study First Received:	July 25, 2006
Last Updated:	August 26, 2014
Health Authority:	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 February 25, 2015