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| Sponsored by: |
UCB |
| Information provided by: | UCB |
| ClinicalTrials.gov Identifier: | NCT00368251 |
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 Drug: Placebo |
Phase III |
| Genetics Home Reference related topics: | familial encephalopathy with neuroserpin inclusion bodies pyridoxal 5'-phosphate-dependent epilepsy Unverricht-Lundborg disease |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| 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: | 56 |
| Study Start Date: | November 2006 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| 1: Placebo Comparator |
Drug: Placebo
Placebo
|
| 2: Experimental |
Drug: Brivaracetam
2.5mg tablet, 5mg bid, 12 weeks
|
| 3: Experimental |
Drug: Brivaracetam
25mg and 50mg tablets, 150mg bid, 12 weeks
|
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| United States, California | |||||
| San Francisco, California, United States | |||||
| United States, New York | |||||
| New York, New York, United States | |||||
| United States, Virginia | |||||
| Charlottesville, Virginia, United States | |||||
| Canada | |||||
| Quebec, Canada | |||||
| Canada, British Columbia | |||||
| Vancouver, British Columbia, Canada | |||||
| Canada, Quebec | |||||
| Montreal, Quebec, Canada | |||||
| Finland | |||||
| Helsinki, Finland | |||||
| France | |||||
| Lille, France | |||||
| Bron, France | |||||
| Paris, France | |||||
| Israel | |||||
| Tel Aviv, Israel | |||||
| Russian Federation | |||||
| Moscow, Russian Federation | |||||
| Samara, Russian Federation | |||||
| Serbia and Montenegro | |||||
| Belgrade, Serbia and Montenegro | |||||
| UCB |
| Study Director: | Dr. Philipp von Rosenstiel | Clinical Program Director Therapeutic Area Neurology/Psychiatry UCB S.A. |
More Information
| Responsible Party: | UCB ( UCB Clinical Trial Call Center ) |
| Study ID Numbers: | N01236, RPCE06C2320 |
| First Received: | August 23, 2006 |
| Last Updated: | March 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00368251 |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; European Union: European Medicines Agency |
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