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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

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Brivaracetam
Sponsored by
UCB PHARMA Inc. (US)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Brivaracetam, Epilepsy, Partial Onset Seizures, open label

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • N01199 1051
  • N01199 1362
  • N01199 1374
  • N01199 1050
  • N01199 1078
  • N01199 1392
  • N01199 1087
  • N01199 1368
  • N01199 1396
  • N01199 1385
  • N01199 1356
  • N01199 1388
  • N01199 1375
  • N01199 1364
  • N01199 1380
  • N01199 1052
  • N01199 1083
  • N01199 1373
  • N01199 1086
  • N01199 1077
  • N01199 1391
  • N01199 1395
  • N01199 1071
  • N01199 1389
  • N01199 1079
  • N01199 1360
  • N01199 1352
  • N01199 1069
  • N01199 1062
  • N01199 1053
  • N01199 1365
  • N01199 1366
  • N01199 1054
  • N01199 1359
  • N01199 1055
  • N01199 1059
  • N01199 1081
  • N01199 1061
  • N01199 1084
  • N01199 1394
  • N01199 1064
  • N01199 1082
  • N01199 1367
  • N01199 1393
  • N01199 1376
  • N01199 1369
  • N01199 1420
  • N01199 1430
  • N01199 1423
  • N01199 1428
  • N01199 1427
  • N01199 1426
  • N01199 1421
  • N01199 1422
  • N01199 1028
  • N01199 1325
  • N01199 1024
  • N01199 1150
  • N01199 1331
  • N01199 1332
  • N01199 1022
  • N01199 1023
  • N01199 1021
  • N01199 1027
  • N01199 1030
  • N01199 1326
  • N01199 1029
  • N01199 1316
  • N01199 1312
  • N01199 1311
  • N01199 1314
  • N01199 1313
  • N01199 1266
  • N01199 1045
  • N01199 1256
  • N01199 1257
  • N01199 1261
  • N01199 1046
  • N01199 1042
  • N01199 1253
  • N01199 1262
  • N01199 1258
  • N01199 1040
  • N01199 1250
  • N01199 1043
  • N01199 1259
  • N01199 1265
  • N01199 1264
  • N01199 1251
  • N01199 1263
  • N01199 1412
  • N01199 1010
  • N01199 1008
  • N01199 1009
  • N01199 1003
  • N01199 1403
  • N01199 1005
  • N01199 1007
  • N01199 1002
  • N01199 1001

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Brivaracetam

Arm Description

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.

Outcomes

Primary Outcome Measures

Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) During the Study Period
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
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
A Serious Adverse Event (SAE) is any untoward medical incidence that occurs at any dose.

Secondary Outcome Measures

Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period
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.
Percent Change in Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period
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.
Percentage of Participants With Response for Partial Onset Seizure (POS) (Type I) Frequency Over the Evaluation Period
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.

Full Information

First Posted
September 6, 2005
Last Updated
August 16, 2021
Sponsor
UCB PHARMA Inc. (US)
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1. Study Identification

Unique Protocol Identification Number
NCT00150800
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB PHARMA Inc. (US)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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].

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Brivaracetam, Epilepsy, Partial Onset Seizures, open label

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
668 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brivaracetam
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Brivaracetam
Intervention Description
Active Substance: Brivaracetam Pharmaceutical Form: Tablet Concentration: 10 mg and 25 mg Route of Administration: Oral
Primary Outcome Measure Information:
Title
Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) During the Study Period
Description
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.
Time Frame
Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
Title
Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study Period
Description
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.
Time Frame
Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
Title
Percentage of Participants With a Serious Adverse Event (SAE) During the Study Period
Description
A Serious Adverse Event (SAE) is any untoward medical incidence that occurs at any dose.
Time Frame
Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
Secondary Outcome Measure Information:
Title
Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period
Description
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.
Time Frame
From Baseline of the previous study to the Evaluation Period (up to 11 years)
Title
Percent Change in Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period
Description
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.
Time Frame
From Baseline of the previous study to the Evaluation Period (up to 11 years)
Title
Percentage of Participants With Response for Partial Onset Seizure (POS) (Type I) Frequency Over the Evaluation Period
Description
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.
Time Frame
From Baseline of the previous study to the Evaluation Period (up to 11 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
+1 844 599 2273 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
N01199 1051
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
N01199 1362
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
N01199 1374
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
N01199 1050
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
N01199 1078
City
Fresno
State/Province
California
Country
United States
Facility Name
N01199 1392
City
Newport Beach
State/Province
California
Country
United States
Facility Name
N01199 1087
City
San Francisco
State/Province
California
Country
United States
Facility Name
N01199 1368
City
San Francisco
State/Province
California
Country
United States
Facility Name
N01199 1396
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
N01199 1385
City
Augusta
State/Province
Georgia
Country
United States
Facility Name
N01199 1356
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
N01199 1388
City
Springfield
State/Province
Illinois
Country
United States
Facility Name
N01199 1375
City
Wichita
State/Province
Kansas
Country
United States
Facility Name
N01199 1364
City
Lexington
State/Province
Kentucky
Country
United States
Facility Name
N01199 1380
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
N01199 1052
City
Paducah
State/Province
Kentucky
Country
United States
Facility Name
N01199 1083
City
Ruston
State/Province
Louisiana
Country
United States
Facility Name
N01199 1373
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
N01199 1086
City
Bethesda
State/Province
Maryland
Country
United States
Facility Name
N01199 1077
City
Burlington
State/Province
Massachusetts
Country
United States
Facility Name
N01199 1391
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
N01199 1395
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
N01199 1071
City
Grand Rapids
State/Province
Michigan
Country
United States
Facility Name
N01199 1389
City
Saint Paul
State/Province
Minnesota
Country
United States
Facility Name
N01199 1079
City
Tupelo
State/Province
Mississippi
Country
United States
Facility Name
N01199 1360
City
Chesterfield
State/Province
Missouri
Country
United States
Facility Name
N01199 1352
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
N01199 1069
City
Great Falls
State/Province
Montana
Country
United States
Facility Name
N01199 1062
City
Toms River
State/Province
New Jersey
Country
United States
Facility Name
N01199 1053
City
New York
State/Province
New York
Country
United States
Facility Name
N01199 1365
City
Rochester
State/Province
New York
Country
United States
Facility Name
N01199 1366
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
N01199 1054
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
N01199 1359
City
Portland
State/Province
Oregon
Country
United States
Facility Name
N01199 1055
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
N01199 1059
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
N01199 1081
City
Greenville
State/Province
South Carolina
Country
United States
Facility Name
N01199 1061
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
N01199 1084
City
Dallas
State/Province
Texas
Country
United States
Facility Name
N01199 1394
City
Dallas
State/Province
Texas
Country
United States
Facility Name
N01199 1064
City
Houston
State/Province
Texas
Country
United States
Facility Name
N01199 1082
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
N01199 1367
City
Charlottesville
State/Province
Virginia
Country
United States
Facility Name
N01199 1393
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
N01199 1376
City
Seattle
State/Province
Washington
Country
United States
Facility Name
N01199 1369
City
Milwaukee
State/Province
Wisconsin
Country
United States
Facility Name
N01199 1420
City
Chatswood
State/Province
New South Wales
Country
Australia
Facility Name
N01199 1430
City
Randwick
State/Province
New South Wales
Country
Australia
Facility Name
N01199 1423
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
N01199 1428
City
Woodville
State/Province
South Australia
Country
Australia
Facility Name
N01199 1427
City
Clayton
State/Province
Victoria
Country
Australia
Facility Name
N01199 1426
City
Parkville
State/Province
Victoria
Country
Australia
Facility Name
N01199 1421
City
West Heidelberg
State/Province
Victoria
Country
Australia
Facility Name
N01199 1422
City
Fitzroy
Country
Australia
Facility Name
N01199 1028
City
Campinas
Country
Brazil
Facility Name
N01199 1325
City
Curitiba
Country
Brazil
Facility Name
N01199 1024
City
Florianopolis
Country
Brazil
Facility Name
N01199 1150
City
Florianópolis
Country
Brazil
Facility Name
N01199 1331
City
Porto Alegre
Country
Brazil
Facility Name
N01199 1332
City
Porto Alegre
Country
Brazil
Facility Name
N01199 1022
City
Riberao Preto
Country
Brazil
Facility Name
N01199 1023
City
Salvador
Country
Brazil
Facility Name
N01199 1021
City
Sao Paulo
Country
Brazil
Facility Name
N01199 1027
City
Sao Paulo
Country
Brazil
Facility Name
N01199 1030
City
Sao Paulo
Country
Brazil
Facility Name
N01199 1326
City
Sao Paulo
Country
Brazil
Facility Name
N01199 1029
City
São José do Rio Preto
Country
Brazil
Facility Name
N01199 1316
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
N01199 1312
City
Greenfield Park
State/Province
Quebec
Country
Canada
Facility Name
N01199 1311
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
N01199 1314
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
N01199 1313
City
Quebec City
State/Province
Quebec
Country
Canada
Facility Name
N01199 1266
City
Mumbai
State/Province
Maharashti
Country
India
Facility Name
N01199 1045
City
Bangalore
Country
India
Facility Name
N01199 1256
City
Bangalore
Country
India
Facility Name
N01199 1257
City
Bangalore
Country
India
Facility Name
N01199 1261
City
Bangalore
Country
India
Facility Name
N01199 1046
City
Chennai
Country
India
Facility Name
N01199 1042
City
Hyderabad
Country
India
Facility Name
N01199 1253
City
Hyderabad
Country
India
Facility Name
N01199 1262
City
Hyderabad
Country
India
Facility Name
N01199 1258
City
Jaipur
Country
India
Facility Name
N01199 1040
City
Lucknow
Country
India
Facility Name
N01199 1250
City
Lucknow
Country
India
Facility Name
N01199 1043
City
Mumbai
Country
India
Facility Name
N01199 1259
City
Mumbai
Country
India
Facility Name
N01199 1265
City
Parel Mumbai
Country
India
Facility Name
N01199 1264
City
Pune Maharashtra
Country
India
Facility Name
N01199 1251
City
Pune
Country
India
Facility Name
N01199 1263
City
Tirupati
Country
India
Facility Name
N01199 1412
City
San Nicholas De Los Garza
State/Province
Nuevo Leon
Country
Mexico
Facility Name
N01199 1010
City
Aguascalientes
Country
Mexico
Facility Name
N01199 1008
City
Chihuahua
Country
Mexico
Facility Name
N01199 1009
City
Chihuahua
Country
Mexico
Facility Name
N01199 1003
City
Guadalajara
Country
Mexico
Facility Name
N01199 1403
City
Mexico City
Country
Mexico
Facility Name
N01199 1005
City
Monterrey
Country
Mexico
Facility Name
N01199 1007
City
Monterrey
Country
Mexico
Facility Name
N01199 1002
City
San Luis Potosi
Country
Mexico
Facility Name
N01199 1001
City
Zapopan
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
32221987
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.
Results Reference
result
PubMed Identifier
34218211
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.
Results Reference
result
PubMed Identifier
26899665
Citation
Markham A. Brivaracetam: First Global Approval. Drugs. 2016 Mar;76(4):517-22. doi: 10.1007/s40265-016-0555-6.
Results Reference
derived

Learn more about this trial

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

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