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An Open-label, Multinational, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Brivaracetam
Sponsored by
UCB Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy, Monotherapy, Partial Onset Seizures

Eligibility Criteria

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

Inclusion Criteria:

  • Subjects with epilepsy who participated in previous brivaracetam trials which allow access to the present trial.
  • Subjects from whom the Investigator believes a reasonable potential benefit from the long-term administration of brivaracetam may be expected.

Exclusion Criteria:

• Severe medical, neurological and psychiatric disorders, including current suicidal ideation or behaviour, or laboratory values which may have an impact on the safety of the subject, as determined by the investigator.

Sites / Locations

  • 304
  • 281
  • 288
  • 240
  • 245
  • 285
  • 224
  • 266
  • 231
  • 278
  • 270
  • 284
  • 241
  • 265
  • 297
  • 260
  • 236
  • 267
  • 268
  • 211
  • 235
  • 218
  • 279
  • 277
  • 213
  • 400
  • 404
  • 402
  • 401
  • 004
  • 003
  • 205
  • 203
  • 206
  • 023
  • 020
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  • 040
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  • 055
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  • 051
  • 065
  • 072
  • 074
  • 084
  • 082
  • 085
  • 083
  • 080
  • 090
  • 100
  • 102
  • 101

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Brivaracetam

Arm Description

Brivaracetam at flexible dosing up to 200mg /day

Outcomes

Primary Outcome Measures

Percentage of Subjects With at Least One Treatment-emergent Adverse Event (TEAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years)
Treatment-emergent Adverse events (TEAE) are any untoward medical occurrences in a subject during administered study treatment, whether or not these events are related to study treatment.
Percentage of Subjects Who Withdrew Due to Adverse Event (AE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years)
Adverse Events (AE) are any untoward medical occurrences in a subject during administered study treatment, whether or not these events are related to study treatment.
Percentage of Subjects With a Serious Adverse Event (SAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years)
An SAE was any untoward medical occurrence that, at any dose resulted in death, was life threatening, required in-subject hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.

Secondary Outcome Measures

Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 3 Months of the Evaluation Period (up to 9 Years)
BRV monotherapy is defined as continuous treatment with BRV only (ie, no treatment with another anti-epileptic drug (AED)). Use of rescue AED for a duration of no more than 2 consecutive days will not disqualify a subject from being defined as on continuous monotherapy provided the use of rescue AED does not exceed more than 1 time per week.
Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 6 Months, of the Evaluation Period (up to 9 Years)
BRV monotherapy is defined as continuous treatment with BRV only (ie, no treatment with another anti-epileptic drug (AED)). Use of rescue AED for a duration of no more than 2 consecutive days will not disqualify a subject from being defined as on continuous monotherapy provided the use of rescue AED does not exceed more than 1 time per week.
Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 12 Months of the Evaluation Period (up to 9 Years)
BRV monotherapy is defined as continuous treatment with BRV only (ie, no treatment with another anti-epileptic drug (AED)). Use of rescue AED for a duration of no more than 2 consecutive days will not disqualify a subject from being defined as on continuous monotherapy provided the use of rescue AED does not exceed more than 1 time per week.

Full Information

First Posted
September 26, 2008
Last Updated
June 13, 2018
Sponsor
UCB Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00761774
Brief Title
An Open-label, Multinational, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam
Official Title
An Open-label, Multinational, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam Used 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
March 2018
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The Sponsor wishes to develop brivaracetam as an anti-epileptic treatment in subjects 16 years and older with epilepsy. This study permits continued access to treatment for subjects who participated in a previous epilepsy study. The study will explore the long-term safety and efficacy of brivaracetam.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Brivaracetam
Arm Type
Experimental
Arm Description
Brivaracetam at flexible dosing up to 200mg /day
Intervention Type
Drug
Intervention Name(s)
Brivaracetam
Other Intervention Name(s)
ucb 34714
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Subjects With at Least One Treatment-emergent Adverse Event (TEAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years)
Description
Treatment-emergent Adverse events (TEAE) are any untoward medical occurrences in a subject during administered study treatment, whether or not these events are related to study treatment.
Time Frame
During the Evaluation Period (up to 9 years)
Title
Percentage of Subjects Who Withdrew Due to Adverse Event (AE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years)
Description
Adverse Events (AE) are any untoward medical occurrences in a subject during administered study treatment, whether or not these events are related to study treatment.
Time Frame
During the Evaluation Period (up to 9 years)
Title
Percentage of Subjects With a Serious Adverse Event (SAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years)
Description
An SAE was any untoward medical occurrence that, at any dose resulted in death, was life threatening, required in-subject hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.
Time Frame
During the Evaluation Period (up to 9 years)
Secondary Outcome Measure Information:
Title
Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 3 Months of the Evaluation Period (up to 9 Years)
Description
BRV monotherapy is defined as continuous treatment with BRV only (ie, no treatment with another anti-epileptic drug (AED)). Use of rescue AED for a duration of no more than 2 consecutive days will not disqualify a subject from being defined as on continuous monotherapy provided the use of rescue AED does not exceed more than 1 time per week.
Time Frame
During the Evaluation Period (up to 9 years)
Title
Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 6 Months, of the Evaluation Period (up to 9 Years)
Description
BRV monotherapy is defined as continuous treatment with BRV only (ie, no treatment with another anti-epileptic drug (AED)). Use of rescue AED for a duration of no more than 2 consecutive days will not disqualify a subject from being defined as on continuous monotherapy provided the use of rescue AED does not exceed more than 1 time per week.
Time Frame
During the Evaluation Period (up to 9 years)
Title
Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 12 Months of the Evaluation Period (up to 9 Years)
Description
BRV monotherapy is defined as continuous treatment with BRV only (ie, no treatment with another anti-epileptic drug (AED)). Use of rescue AED for a duration of no more than 2 consecutive days will not disqualify a subject from being defined as on continuous monotherapy provided the use of rescue AED does not exceed more than 1 time per week.
Time Frame
During the Evaluation Period (up to 9 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects with epilepsy who participated in previous brivaracetam trials which allow access to the present trial. Subjects from whom the Investigator believes a reasonable potential benefit from the long-term administration of brivaracetam may be expected. Exclusion Criteria: • Severe medical, neurological and psychiatric disorders, including current suicidal ideation or behaviour, or laboratory values which may have an impact on the safety of the subject, as determined by the investigator.
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
304
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
281
City
Fresno
State/Province
California
Country
United States
Facility Name
288
City
Pasadena
State/Province
California
Country
United States
Facility Name
240
City
Riverside
State/Province
California
Country
United States
Facility Name
245
City
Sacramento
State/Province
California
Country
United States
Facility Name
285
City
Peoria
State/Province
Illinois
Country
United States
Facility Name
224
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
266
City
Lexington
State/Province
Kentucky
Country
United States
Facility Name
231
City
Waldorf
State/Province
Maryland
Country
United States
Facility Name
278
City
Burlington
State/Province
Massachusetts
Country
United States
Facility Name
270
City
New York
State/Province
New York
Country
United States
Facility Name
284
City
Hickory
State/Province
North Carolina
Country
United States
Facility Name
241
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
265
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
297
City
Germantown
State/Province
Tennessee
Country
United States
Facility Name
260
City
Austin
State/Province
Texas
Country
United States
Facility Name
236
City
Bedford
State/Province
Texas
Country
United States
Facility Name
267
City
Dallas
State/Province
Texas
Country
United States
Facility Name
268
City
Houston
State/Province
Texas
Country
United States
Facility Name
211
City
Layton
State/Province
Utah
Country
United States
Facility Name
235
City
Ogden
State/Province
Utah
Country
United States
Facility Name
218
City
Burlington
State/Province
Vermont
Country
United States
Facility Name
279
City
Danville
State/Province
Virginia
Country
United States
Facility Name
277
City
Charleston
State/Province
West Virginia
Country
United States
Facility Name
213
City
Marshfield
State/Province
Wisconsin
Country
United States
Facility Name
400
City
Chatswood
State/Province
New South Wales
Country
Australia
Facility Name
404
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
402
City
Fitzroy
State/Province
Victoria
Country
Australia
Facility Name
401
City
Parkville
State/Province
Victoria
Country
Australia
Facility Name
004
City
Gent
Country
Belgium
Facility Name
003
City
Kortrijk
Country
Belgium
Facility Name
205
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
203
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
206
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
023
City
Brno
Country
Czechia
Facility Name
020
City
Litomysl
Country
Czechia
Facility Name
021
City
Ostava
Country
Czechia
Facility Name
024
City
Ostrava-Trebovice
Country
Czechia
Facility Name
026
City
Praha 4
Country
Czechia
Facility Name
040
City
Bethune
Country
France
Facility Name
041
City
Toulouse Cedex 09
Country
France
Facility Name
055
City
Berlin
Country
Germany
Facility Name
056
City
Bernau
Country
Germany
Facility Name
054
City
Bielefeld
Country
Germany
Facility Name
063
City
Mainz
Country
Germany
Facility Name
051
City
Munchen
Country
Germany
Facility Name
065
City
Regensburg
Country
Germany
Facility Name
072
City
Budapest
Country
Hungary
Facility Name
074
City
Budapest
Country
Hungary
Facility Name
084
City
Bergamo
Country
Italy
Facility Name
082
City
Messina
Country
Italy
Facility Name
085
City
Orbassano
Country
Italy
Facility Name
083
City
Perugia
Country
Italy
Facility Name
080
City
Pisa
Country
Italy
Facility Name
090
City
Madrid
Country
Spain
Facility Name
100
City
Goteborg
Country
Sweden
Facility Name
102
City
Lund
Country
Sweden
Facility Name
101
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Citations:
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
Links:
URL
https://www.briviact.com/briviact-PI.pdf?v=1479491757
Description
Product Information
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

An Open-label, Multinational, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam

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