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| 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 |
| 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| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |
| Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
More Information
| 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 |
|
Unverricht-Lundborg disease Baltic myoclonus progressive myoclonic epilepsies myoclonus brivaracetam |
|
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 |