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
- Registration Number
- NCT00150800
- Lead Sponsor
- UCB PHARMA Inc. (US)
- Brief Summary
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.
- Detailed Description
Study access was limited to subjects having completed one of the previous brivaracetam (BRV) studies: N01193 \[NCT00175825\], N01252 \[NCT00490035\], N01253 \[NCT00464269\], N01254 \[NCT00504881\].
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 668
- Male/ female subjects from 16 years and on. Subjects under 18 years may only be included where legally permitted and ethically accepted
- 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
- Severe medical, neurological and psychiatric disorders or laboratory values which may have an impact on the safety of the subject
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Brivaracetam 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) During the Study Period Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years) Treatment-Emergent Adverse Events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study Period Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years) Adverse Events (AE) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
Percentage of Participants With a Serious Adverse Event (SAE) During the Study Period Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years) A Serious Adverse Event (SAE) is any untoward medical incidence that occurs at any dose.
- Secondary Outcome Measures
Name Time Method Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period From Baseline of the previous study to the Evaluation Period (up to 11 years) Baseline is the Baseline from subject's previous study of enrollment period. N01193 \[NCT00175825\], N01252 \[NCT00490035\], N01253 \[NCT00464269\], N01254 \[NCT00504881\].
A 28 day Type 1 seizure frequency is the total number of Type 1 seizures divided by the total number of days evaluated multiplied by 28.Percentage of Participants With Response for Partial Onset Seizure (POS) (Type I) Frequency Over the Evaluation Period From Baseline of the previous study to the Evaluation Period (up to 11 years) A responder is defined as a subject with a higher than or equal to (\>=) 50 % change in seizure frequency from Baseline period of the previous study.
Percent Change in Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period From Baseline of the previous study to the Evaluation Period (up to 11 years) The percent change from the previous study baselines, in Partial Onset Seizure (POS) (Type I) frequency per 28 days is defined as:
(the value at the previous study baselines) minus (the value at each time-points during the evaluation period) divided by the value at the previous study baselines.
Trial Locations
- Locations (100)
N01199 1392
🇺🇸Newport Beach, California, United States
N01199 1396
🇺🇸Atlanta, Georgia, United States
N01199 1077
🇺🇸Burlington, Massachusetts, United States
N01199 1079
🇺🇸Tupelo, Mississippi, United States
N01199 1251
🇮🇳Pune, India
N01199 1369
🇺🇸Milwaukee, Wisconsin, United States
N01199 1427
🇦🇺Clayton, Victoria, Australia
N01199 1388
🇺🇸Springfield, Illinois, United States
N01199 1364
🇺🇸Lexington, Kentucky, United States
N01199 1375
🇺🇸Wichita, Kansas, United States
N01199 1373
🇺🇸Baltimore, Maryland, United States
N01199 1052
🇺🇸Paducah, Kentucky, United States
N01199 1086
🇺🇸Bethesda, Maryland, United States
N01199 1071
🇺🇸Grand Rapids, Michigan, United States
N01199 1028
🇧🇷Campinas, Brazil
N01199 1426
🇦🇺Parkville, Victoria, Australia
N01199 1352
🇺🇸Saint Louis, Missouri, United States
N01199 1022
🇧🇷Riberao Preto, Brazil
N01199 1421
🇦🇺West Heidelberg, Victoria, Australia
N01199 1257
🇮🇳Bangalore, India
N01199 1021
🇧🇷Sao Paulo, Brazil
N01199 1326
🇧🇷Sao Paulo, Brazil
N01199 1422
🇦🇺Fitzroy, Australia
N01199 1062
🇺🇸Toms River, New Jersey, United States
N01199 1393
🇺🇸Richmond, Virginia, United States
N01199 1261
🇮🇳Bangalore, India
N01199 1150
🇧🇷Florianópolis, Brazil
N01199 1428
🇦🇺Woodville, South Australia, Australia
N01199 1253
🇮🇳Hyderabad, India
N01199 1265
🇮🇳Parel Mumbai, India
N01199 1362
🇺🇸Phoenix, Arizona, United States
N01199 1061
🇺🇸Nashville, Tennessee, United States
N01199 1391
🇺🇸Detroit, Michigan, United States
N01199 1051
🇺🇸Phoenix, Arizona, United States
N01199 1087
🇺🇸San Francisco, California, United States
N01199 1366
🇺🇸Cincinnati, Ohio, United States
N01199 1368
🇺🇸San Francisco, California, United States
N01199 1064
🇺🇸Houston, Texas, United States
N01199 1082
🇺🇸Salt Lake City, Utah, United States
N01199 1376
🇺🇸Seattle, Washington, United States
N01199 1359
🇺🇸Portland, Oregon, United States
N01199 1316
🇨🇦Edmonton, Alberta, Canada
N01199 1311
🇨🇦Montreal, Quebec, Canada
N01199 1313
🇨🇦Quebec City, Quebec, Canada
N01199 1332
🇧🇷Porto Alegre, Brazil
N01199 1023
🇧🇷Salvador, Brazil
N01199 1027
🇧🇷Sao Paulo, Brazil
N01199 1030
🇧🇷Sao Paulo, Brazil
N01199 1029
🇧🇷São José do Rio Preto, Brazil
N01199 1266
🇮🇳Mumbai, Maharashti, India
N01199 1264
🇮🇳Pune Maharashtra, India
N01199 1412
🇲🇽San Nicholas De Los Garza, Nuevo Leon, Mexico
N01199 1403
🇲🇽Mexico City, Mexico
N01199 1045
🇮🇳Bangalore, India
N01199 1259
🇮🇳Mumbai, India
N01199 1002
🇲🇽San Luis Potosi, Mexico
N01199 1262
🇮🇳Hyderabad, India
N01199 1263
🇮🇳Tirupati, India
N01199 1010
🇲🇽Aguascalientes, Mexico
N01199 1005
🇲🇽Monterrey, Mexico
N01199 1043
🇮🇳Mumbai, India
N01199 1008
🇲🇽Chihuahua, Mexico
N01199 1003
🇲🇽Guadalajara, Mexico
N01199 1007
🇲🇽Monterrey, Mexico
N01199 1069
🇺🇸Great Falls, Montana, United States
N01199 1256
🇮🇳Bangalore, India
N01199 1046
🇮🇳Chennai, India
N01199 1258
🇮🇳Jaipur, India
N01199 1250
🇮🇳Lucknow, India
N01199 1050
🇺🇸Little Rock, Arkansas, United States
N01199 1385
🇺🇸Augusta, Georgia, United States
N01199 1356
🇺🇸Chicago, Illinois, United States
N01199 1395
🇺🇸Detroit, Michigan, United States
N01199 1389
🇺🇸Saint Paul, Minnesota, United States
N01199 1360
🇺🇸Chesterfield, Missouri, United States
N01199 1053
🇺🇸New York, New York, United States
N01199 1394
🇺🇸Dallas, Texas, United States
N01199 1420
🇦🇺Chatswood, New South Wales, Australia
N01199 1423
🇦🇺Adelaide, South Australia, Australia
N01199 1024
🇧🇷Florianopolis, Brazil
N01199 1430
🇦🇺Randwick, New South Wales, Australia
N01199 1325
🇧🇷Curitiba, Brazil
N01199 1331
🇧🇷Porto Alegre, Brazil
N01199 1312
🇨🇦Greenfield Park, Quebec, Canada
N01199 1314
🇨🇦Montreal, Quebec, Canada
N01199 1042
🇮🇳Hyderabad, India
N01199 1040
🇮🇳Lucknow, India
N01199 1009
🇲🇽Chihuahua, Mexico
N01199 1001
🇲🇽Zapopan, Mexico
N01199 1380
🇺🇸Louisville, Kentucky, United States
N01199 1374
🇺🇸Tucson, Arizona, United States
N01199 1083
🇺🇸Ruston, Louisiana, United States
N01199 1078
🇺🇸Fresno, California, United States
N01199 1054
🇺🇸Columbus, Ohio, United States
N01199 1365
🇺🇸Rochester, New York, United States
N01199 1055
🇺🇸Philadelphia, Pennsylvania, United States
N01199 1081
🇺🇸Greenville, South Carolina, United States
N01199 1059
🇺🇸Philadelphia, Pennsylvania, United States
N01199 1084
🇺🇸Dallas, Texas, United States
N01199 1367
🇺🇸Charlottesville, Virginia, United States