This Trial, Evaluating the Long-term Safety and Tolerability of Brivaracetam Will Provide Subjects Suffering From Epilepsy, Who May Have Benefited From Brivaracetam as Adjunctive Treatment, the Opportunity to Receive Open Label Brivaracetam Treatment
NCT ID: NCT00150800
Last Updated: 2021-08-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
668 participants
INTERVENTIONAL
2006-01-31
2017-09-30
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 used as adjunctive treatment, flexible dosing up to 200 mg /day in b.i.d (twice daily) administration. Dose increase or decrease can be made in increments of maximum 50 mg/day on a weekly basis.
Brivaracetam
* Active Substance: Brivaracetam
* Pharmaceutical Form: Tablet
* Concentration: 10 mg and 25 mg
* Route of Administration: Oral
Interventions
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Brivaracetam
* Active Substance: Brivaracetam
* Pharmaceutical Form: Tablet
* Concentration: 10 mg and 25 mg
* Route of Administration: Oral
Eligibility Criteria
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Inclusion Criteria
* Subjects with epilepsy who have participated in previous brivaracetam trials which allow access to the present study
* Subjects for whom the investigator believes a reasonable benefit from the long term administration of brivaracetam may be expected
* Female subjects without childbearing potential. Female subjects with child bearing potential are eligible if they use a medically accepted contraceptive method for the duration of the study
* Subject/ legally acceptable representative considered as reliable and capable of adhering to the protocol, visit schedule or medication intake according to the judgment of the Investigator
Exclusion Criteria
* Poor compliance with the visit schedule or medication intake in the previous brivaracetam study
* Pregnant or lactating women
* Participation in any clinical study of another investigational drug or device during the study
16 Years
ALL
No
Sponsors
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UCB PHARMA Inc. (US)
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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N01199 1051
Phoenix, Arizona, United States
N01199 1362
Phoenix, Arizona, United States
N01199 1374
Tucson, Arizona, United States
N01199 1050
Little Rock, Arkansas, United States
N01199 1078
Fresno, California, United States
N01199 1392
Newport Beach, California, United States
N01199 1087
San Francisco, California, United States
N01199 1368
San Francisco, California, United States
N01199 1396
Atlanta, Georgia, United States
N01199 1385
Augusta, Georgia, United States
N01199 1356
Chicago, Illinois, United States
N01199 1388
Springfield, Illinois, United States
N01199 1375
Wichita, Kansas, United States
N01199 1364
Lexington, Kentucky, United States
N01199 1380
Louisville, Kentucky, United States
N01199 1052
Paducah, Kentucky, United States
N01199 1083
Ruston, Louisiana, United States
N01199 1373
Baltimore, Maryland, United States
N01199 1086
Bethesda, Maryland, United States
N01199 1077
Burlington, Massachusetts, United States
N01199 1391
Detroit, Michigan, United States
N01199 1395
Detroit, Michigan, United States
N01199 1071
Grand Rapids, Michigan, United States
N01199 1389
Saint Paul, Minnesota, United States
N01199 1079
Tupelo, Mississippi, United States
N01199 1360
Chesterfield, Missouri, United States
N01199 1352
St Louis, Missouri, United States
N01199 1069
Great Falls, Montana, United States
N01199 1062
Toms River, New Jersey, United States
N01199 1053
New York, New York, United States
N01199 1365
Rochester, New York, United States
N01199 1366
Cincinnati, Ohio, United States
N01199 1054
Columbus, Ohio, United States
N01199 1359
Portland, Oregon, United States
N01199 1055
Philadelphia, Pennsylvania, United States
N01199 1059
Philadelphia, Pennsylvania, United States
N01199 1081
Greenville, South Carolina, United States
N01199 1061
Nashville, Tennessee, United States
N01199 1084
Dallas, Texas, United States
N01199 1394
Dallas, Texas, United States
N01199 1064
Houston, Texas, United States
N01199 1082
Salt Lake City, Utah, United States
N01199 1367
Charlottesville, Virginia, United States
N01199 1393
Richmond, Virginia, United States
N01199 1376
Seattle, Washington, United States
N01199 1369
Milwaukee, Wisconsin, United States
N01199 1420
Chatswood, New South Wales, Australia
N01199 1430
Randwick, New South Wales, Australia
N01199 1423
Adelaide, South Australia, Australia
N01199 1428
Woodville, South Australia, Australia
N01199 1427
Clayton, Victoria, Australia
N01199 1426
Parkville, Victoria, Australia
N01199 1421
West Heidelberg, Victoria, Australia
N01199 1422
Fitzroy, , Australia
N01199 1028
Campinas, , Brazil
N01199 1325
Curitiba, , Brazil
N01199 1024
Florianópolis, , Brazil
N01199 1150
Florianópolis, , Brazil
N01199 1331
Porto Alegre, , Brazil
N01199 1332
Porto Alegre, , Brazil
N01199 1022
Riberao Preto, , Brazil
N01199 1023
Salvador, , Brazil
N01199 1029
São José do Rio Preto, , Brazil
N01199 1021
São Paulo, , Brazil
N01199 1027
São Paulo, , Brazil
N01199 1030
São Paulo, , Brazil
N01199 1326
São Paulo, , Brazil
N01199 1316
Edmonton, Alberta, Canada
N01199 1312
Greenfield Park, Quebec, Canada
N01199 1311
Montreal, Quebec, Canada
N01199 1314
Montreal, Quebec, Canada
N01199 1313
Québec, Quebec, Canada
N01199 1266
Mumbai, Maharashti, India
N01199 1045
Bangalore, , India
N01199 1256
Bangalore, , India
N01199 1257
Bangalore, , India
N01199 1261
Bangalore, , India
N01199 1046
Chennai, , India
N01199 1042
Hyderabad, , India
N01199 1253
Hyderabad, , India
N01199 1262
Hyderabad, , India
N01199 1258
Jaipur, , India
N01199 1040
Lucknow, , India
N01199 1250
Lucknow, , India
N01199 1043
Mumbai, , India
N01199 1259
Mumbai, , India
N01199 1265
Parel Mumbai, , India
N01199 1251
Pune, , India
N01199 1264
Pune Maharashtra, , India
N01199 1263
Tirupati, , India
N01199 1412
San Nicholas de Los Garza, Nuevo León, Mexico
N01199 1010
Aguascalientes, , Mexico
N01199 1008
Chihuahua City, , Mexico
N01199 1009
Chihuahua City, , Mexico
N01199 1003
Guadalajara, , Mexico
N01199 1403
Mexico City, , Mexico
N01199 1005
Monterrey, , Mexico
N01199 1007
Monterrey, , Mexico
N01199 1002
San Luis Potosí City, , Mexico
N01199 1001
Zapopan, , Mexico
Countries
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References
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O'Brien TJ, Borghs S, He QJ, Schulz AL, Yates S, Biton V. Long-term safety, efficacy, and quality of life outcomes with adjunctive brivaracetam treatment at individualized doses in patients with epilepsy: An up to 11-year, open-label, follow-up trial. Epilepsia. 2020 Apr;61(4):636-646. doi: 10.1111/epi.16484. Epub 2020 Mar 28.
Moseley BD, Dimova S, Elmoufti S, Laloyaux C, Asadi-Pooya AA. Long-term efficacy and tolerability of adjunctive brivaracetam in adults with focal to bilateral tonic-clonic (secondary generalized) seizures: Post hoc pooled analysis. Epilepsy Res. 2021 Oct;176:106694. doi: 10.1016/j.eplepsyres.2021.106694. Epub 2021 Jun 24.
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
Other Identifiers
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N01199
Identifier Type: -
Identifier Source: org_study_id
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