Clinical trial NCT00150800: 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
Official title: An Open-label, Multi-center, Follow-up Trial to Evaluate Long Term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment at a Flexible Dose up to a Maximum of 200 mg/Day in Subjects Aged 16 Years or Older Suffering From Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Keywords: Brivaracetam
Epilepsy
Partial Onset Seizures
open label
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 668
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 \[NCT00504881\].

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) During the Study Period
timeFrame: Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
measure: Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study Period
timeFrame: Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
measure: Percentage of Participants With a Serious Adverse Event (SAE) During the Study Period
timeFrame: Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
Secondary outcomes:
measure: Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period
timeFrame: From Baseline of the previous study to the Evaluation Period (up to 11 years)
measure: Percent Change in Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period
timeFrame: From Baseline of the previous study to the Evaluation Period (up to 11 years)
measure: Percentage of Participants With Response for Partial Onset Seizure (POS) (Type I) Frequency Over the Evaluation Period
timeFrame: From Baseline of the previous study to the Evaluation Period (up to 11 years)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: N01199 1051
state: Arizona
city: Phoenix
country: United States
facility: N01199 1362
state: Arizona
city: Tucson
country: United States
facility: N01199 1374
state: Arizona
city: Little Rock
country: United States
facility: N01199 1050
state: Arkansas
city: Fresno
country: United States
facility: N01199 1078
state: California
city: Newport Beach
country: United States
facility: N01199 1392
state: California
city: San Francisco
country: United States
facility: N01199 1087
state: California
city: San Francisco
country: United States
facility: N01199 1368
state: California
city: Atlanta
country: United States
facility: N01199 1396
state: Georgia
city: Augusta
country: United States
facility: N01199 1385
state: Georgia
city: Chicago
country: United States
facility: N01199 1356
state: Illinois
city: Springfield
country: United States
facility: N01199 1388
state: Illinois
city: Wichita
country: United States
facility: N01199 1375
state: Kansas
city: Lexington
country: United States
facility: N01199 1364
state: Kentucky
city: Louisville
country: United States
facility: N01199 1380
state: Kentucky
city: Paducah
country: United States
facility: N01199 1052
state: Kentucky
city: Ruston
country: United States
facility: N01199 1083
state: Louisiana
city: Baltimore
country: United States
facility: N01199 1373
state: Maryland
city: Bethesda
country: United States
facility: N01199 1086
state: Maryland
city: Burlington
country: United States
facility: N01199 1077
state: Massachusetts
city: Detroit
country: United States
facility: N01199 1391
state: Michigan
city: Detroit
country: United States
facility: N01199 1395
state: Michigan
city: Grand Rapids
country: United States
facility: N01199 1071
state: Michigan
city: Saint Paul
country: United States
facility: N01199 1389
state: Minnesota
city: Tupelo
country: United States
facility: N01199 1079
state: Mississippi
city: Chesterfield
country: United States
facility: N01199 1360
state: Missouri
city: Saint Louis
country: United States
facility: N01199 1352
state: Missouri
city: Great Falls
country: United States
facility: N01199 1069
state: Montana
city: Toms River
country: United States
facility: N01199 1062
state: New Jersey
city: New York
country: United States
facility: N01199 1053
state: New York
city: Rochester
country: United States
facility: N01199 1365
state: New York
city: Cincinnati
country: United States
facility: N01199 1366
state: Ohio
city: Columbus
country: United States
facility: N01199 1054
state: Ohio
city: Portland
country: United States
facility: N01199 1359
state: Oregon
city: Philadelphia
country: United States
facility: N01199 1055
state: Pennsylvania
city: Philadelphia
country: United States
facility: N01199 1059
state: Pennsylvania
city: Greenville
country: United States
facility: N01199 1081
state: South Carolina
city: Nashville
country: United States
facility: N01199 1061
state: Tennessee
city: Dallas
country: United States
facility: N01199 1084
state: Texas
city: Dallas
country: United States
facility: N01199 1394
state: Texas
city: Houston
country: United States
facility: N01199 1064
state: Texas
city: Salt Lake City
country: United States
facility: N01199 1082
state: Utah
city: Charlottesville
country: United States
facility: N01199 1367
state: Virginia
city: Richmond
country: United States
facility: N01199 1393
state: Virginia
city: Seattle
country: United States
facility: N01199 1376
state: Washington
city: Milwaukee
country: United States
facility: N01199 1369
state: Wisconsin
city: Chatswood
country: Australia
facility: N01199 1420
state: New South Wales
city: Randwick
country: Australia
facility: N01199 1430
state: New South Wales
city: Adelaide
country: Australia
facility: N01199 1423
state: South Australia
city: Woodville
country: Australia
facility: N01199 1428
state: South Australia
city: Clayton
country: Australia
facility: N01199 1427
state: Victoria
city: Parkville
country: Australia
facility: N01199 1426
state: Victoria
city: West Heidelberg
country: Australia
facility: N01199 1421
state: Victoria
city: Fitzroy
country: Australia
facility: N01199 1422
city: Campinas
country: Brazil
facility: N01199 1028
city: Curitiba
country: Brazil
facility: N01199 1325
city: Florianopolis
country: Brazil
facility: N01199 1024
city: Florianópolis
country: Brazil
facility: N01199 1150
city: Porto Alegre
country: Brazil
facility: N01199 1331
city: Porto Alegre
country: Brazil
facility: N01199 1332
city: Riberao Preto
country: Brazil
facility: N01199 1022
city: Salvador
country: Brazil
facility: N01199 1023
city: Sao Paulo
country: Brazil
facility: N01199 1021
city: Sao Paulo
country: Brazil
facility: N01199 1027
city: Sao Paulo
country: Brazil
facility: N01199 1030
city: Sao Paulo
country: Brazil
facility: N01199 1326
city: São José do Rio Preto
country: Brazil
facility: N01199 1029
city: Edmonton
country: Canada
facility: N01199 1316
state: Alberta
city: Greenfield Park
country: Canada
facility: N01199 1312
state: Quebec
city: Montreal
country: Canada
facility: N01199 1311
state: Quebec
city: Montreal
country: Canada
facility: N01199 1314
state: Quebec
city: Quebec City
country: Canada
facility: N01199 1313
state: Quebec
city: Mumbai
country: India
facility: N01199 1266
state: Maharashti
city: Bangalore
country: India
facility: N01199 1045
city: Bangalore
country: India
facility: N01199 1256
city: Bangalore
country: India
facility: N01199 1257
city: Bangalore
country: India
facility: N01199 1261
city: Chennai
country: India
facility: N01199 1046
city: Hyderabad
country: India
facility: N01199 1042
city: Hyderabad
country: India
facility: N01199 1253
city: Hyderabad
country: India
facility: N01199 1262
city: Jaipur
country: India
facility: N01199 1258
city: Lucknow
country: India
facility: N01199 1040
city: Lucknow
country: India
facility: N01199 1250
city: Mumbai
country: India
facility: N01199 1043
city: Mumbai
country: India
facility: N01199 1259
city: Parel Mumbai
country: India
facility: N01199 1265
city: Pune Maharashtra
country: India
facility: N01199 1264
city: Pune
country: India
facility: N01199 1251
city: Tirupati
country: India
facility: N01199 1263
city: San Nicholas De Los Garza
country: Mexico
facility: N01199 1412
state: Nuevo Leon
city: Aguascalientes
country: Mexico
facility: N01199 1010
city: Chihuahua
country: Mexico
facility: N01199 1008
city: Chihuahua
country: Mexico
facility: N01199 1009
city: Guadalajara
country: Mexico
facility: N01199 1003
city: Mexico City
country: Mexico
facility: N01199 1403
city: Monterrey
country: Mexico
facility: N01199 1005
city: Monterrey
country: Mexico
facility: N01199 1007
city: San Luis Potosi
country: Mexico
facility: N01199 1002
city: Zapopan
country: Mexico
facility: N01199 1001
Study officials:
affiliation: +1 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: Markham A. Brivaracetam: First Global Approval. Drugs. 2016 Mar;76(4):517-22. doi: 10.1007/s40265-016-0555-6.