Brivaracetam as add-on Treatment of Unverricht-Lundborg Disease in Adolescents and Adults
This study has been completed.
Sponsor:
UCB, Inc.
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00357669
First received: July 25, 2006
Last updated: August 4, 2009
Last verified: August 2009
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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
MedlinePlus related topics:
Epilepsy
U.S. FDA Resources
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 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
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, Inc.
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 |
| Study First Received: | July 25, 2006 |
| Last Updated: | August 4, 2009 |
| 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:
|
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 17, 2013