An Open-label, Multinational, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam
NCT ID: NCT00761774
Last Updated: 2018-07-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
108 participants
INTERVENTIONAL
2008-11-30
2017-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Brivaracetam
Brivaracetam at flexible dosing up to 200mg /day
Brivaracetam
Subjects will begin at a recommended dose of Brivaracetam 100 mg/day. Subjects will continue treatment at a dose up to a maximum of 200 mg/day with a twice per day administration. Up- and down-titration steps may be performed in steps of a maximum of 50 mg/day on a weekly basis. Full down-titration should include a one week step on 20 mg/day. The study medication will come in 10 mg and 25 mg tablet strengths.
Interventions
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Brivaracetam
Subjects will begin at a recommended dose of Brivaracetam 100 mg/day. Subjects will continue treatment at a dose up to a maximum of 200 mg/day with a twice per day administration. Up- and down-titration steps may be performed in steps of a maximum of 50 mg/day on a weekly basis. Full down-titration should include a one week step on 20 mg/day. The study medication will come in 10 mg and 25 mg tablet strengths.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects from whom the Investigator believes a reasonable potential benefit from the long-term administration of brivaracetam may be expected.
Exclusion Criteria
16 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
+1 844 599 2273(UCB)
Locations
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304
Phoenix, Arizona, United States
281
Fresno, California, United States
288
Pasadena, California, United States
240
Riverside, California, United States
245
Sacramento, California, United States
285
Peoria, Illinois, United States
224
Indianapolis, Indiana, United States
266
Lexington, Kentucky, United States
231
Waldorf, Maryland, United States
278
Burlington, Massachusetts, United States
270
New York, New York, United States
284
Hickory, North Carolina, United States
241
Columbus, Ohio, United States
265
Oklahoma City, Oklahoma, United States
297
Germantown, Tennessee, United States
260
Austin, Texas, United States
236
Bedford, Texas, United States
267
Dallas, Texas, United States
268
Houston, Texas, United States
211
Layton, Utah, United States
235
Ogden, Utah, United States
218
Burlington, Vermont, United States
279
Danville, Virginia, United States
277
Charleston, West Virginia, United States
213
Marshfield, Wisconsin, United States
400
Chatswood, New South Wales, Australia
404
Adelaide, South Australia, Australia
402
Fitzroy, Victoria, Australia
401
Parkville, Victoria, Australia
004
Ghent, , Belgium
003
Kortrijk, , Belgium
205
Calgary, Alberta, Canada
203
Edmonton, Alberta, Canada
206
Toronto, Ontario, Canada
023
Brno, , Czechia
020
Litomyšl, , Czechia
021
Ostava, , Czechia
024
Ostrava-Trebovice, , Czechia
026
Prague, , Czechia
040
Béthune, , France
041
Toulouse, , France
055
Berlin, , Germany
056
Bernau, , Germany
054
Bielefeld, , Germany
063
Mainz, , Germany
051
München, , Germany
065
Regensburg, , Germany
072
Budapest, , Hungary
074
Budapest, , Hungary
084
Bergamo, , Italy
082
Messina, , Italy
085
Orbassano, , Italy
083
Perugia, , Italy
080
Pisa, , Italy
090
Madrid, , Spain
100
Gothenburg, , Sweden
102
Lund, , Sweden
101
Stockholm, , Sweden
Countries
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References
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Markham A. Brivaracetam: First Global Approval. Drugs. 2016 Mar;76(4):517-22. doi: 10.1007/s40265-016-0555-6.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Product Information
FDA Safety Alerts and Recalls
Other Identifiers
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2008-001433-98
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
N01315
Identifier Type: -
Identifier Source: org_study_id
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