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A Study to Evaluate the Efficacy and Safety of Brivaracetam in Study Participants (>=16 to 80 Years of Age) With Epilepsy

Primary Purpose

Partial Seizures With or Without Secondary Generalization, Epilepsy

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

About this trial

This is an interventional treatment trial for Partial Seizures With or Without Secondary Generalization focused on measuring Epilepsy, Partial seizures with or without secondary generalization, Brivaracetam, Briviact

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects (male or female) from 16 to 80 years of age at Visit 1, both inclusive
  • Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method
  • Subjects having at least 8 partial seizures (according to the 1981 ILAE classification) during the 8-Week Baseline Period with at least 2 partial seizures during each 4-week interval of the Baseline Period
  • Subjects having at least 2 partial seizures whether or not secondary generalization per month during the 3 months preceding Visit 1
  • Subjects uncontrolled while treated by 1 or 2 permitted concomitant antiepileptic drug [AED](s). Vagal Nerve Stimulation (VNS) is allowed and will be counted as a concomitant AED

Exclusion Criteria:

  • Subject has history or presence of status epilepticus during the year preceding Visit 1 or during Baseline
  • Subject is currently treated with levetiracetam
  • Subject has taken levetiracetam within 90 days prior to Visit 1

Sites / Locations

  • Ep0083 905
  • Ep0083 906
  • Ep0083 907
  • Ep0083 901
  • Ep0083 902
  • Ep0083 909
  • Ep0083 917
  • Ep0083 920
  • Ep0083 922
  • Ep0083 924
  • Ep0083 912
  • Ep0083 908
  • Ep0083 921
  • Ep0083 926
  • Ep0083 910
  • Ep0083 925
  • Ep0083 913
  • Ep0083 927
  • Ep0083 930
  • Ep0083 916
  • Ep0083 918
  • Ep0083 904
  • Ep0083 923
  • Ep0083 148
  • Ep0083 116
  • Ep0083 126
  • Ep0083 127
  • Ep0083 146
  • Ep0083 122
  • Ep0083 111
  • Ep0083 141
  • Ep0083 110
  • Ep0083 121
  • Ep0083 102
  • Ep0083 142
  • Ep0083 140
  • Ep0083 123
  • Ep0083 115
  • Ep0083 132
  • Ep0083 112
  • Ep0083 128
  • Ep0083 124
  • Ep0083 147
  • Ep0083 105
  • Ep0083 118
  • Ep0083 136
  • Ep0083 117
  • Ep0083 129
  • Ep0083 106
  • Ep0083 114
  • Ep0083 101
  • Ep0083 103
  • Ep0083 144
  • Ep0083 104
  • Ep0083 108
  • Ep0083 137
  • Ep0083 138
  • Ep0083 133
  • Ep0083 109
  • Ep0083 120
  • Ep0083 150
  • Ep0083 130
  • Ep0083 131
  • Ep0083 207
  • Ep0083 201
  • Ep0083 206
  • Ep0083 204
  • Ep0083 209
  • Ep0083 202
  • Ep0083 208
  • Ep0083 203
  • Ep0083 303
  • Ep0083 304
  • Ep0083 306
  • Ep0083 307
  • Ep0083 301
  • Ep0083 302
  • Ep0083 310
  • Ep0083 309
  • Ep0083 401
  • Ep0083 402
  • Ep0083 502
  • Ep0083 505
  • Ep0083 504
  • Ep0083 503
  • Ep0083 501
  • Ep0083 602
  • Ep0083 605
  • Ep0083 606
  • Ep0083 607
  • Ep0083 609
  • Ep0083 601
  • Ep0083 603
  • Ep0083 608

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

BRV 50 mg/day

BRV 200 mg/day

Arm Description

12 weeks Treatment Period: Subjects will receive Placebo 4 weeks Down-Titration Period: Subjects will receive Placebo

12 weeks Treatment Period: Subjects will receive BRV 50 mg/day - Subjects entering into the Long term follow up (LTFU) study or managed access program (MAP): 2 weeks Transition Period: Subjects will receive BRV 50 mg/day followed by LTFU or MAP: Subjects will receive BRV 100 mg/day - Subjects not entering into the LTFU study or MAP: 4 weeks Down-Titration Period: Subjects will receive BRV 25 mg/day for 1 week followed by Placebo for 3 weeks, followed by a Study Drug-Free Period

12 weeks Treatment Period: Subjects will receive BRV 200 mg/day - Subjects entering into the Long term follow up (LTFU) study or managed access program (MAP): 2 weeks Transition Period: Subjects will receive BRV 150 mg/day followed by LTFU or MAP: Subjects will receive BRV 100 mg/day - Subjects not entering into the LTFU study or MAP: 4 weeks Down-Titration Period: Subjects will receive BRV 150 mg/day for 1 week followed by BRV 100 mg/day for 1 week, followed by BRV 50 mg/day for 1 week, followed by BRV 25 mg/day for 1 week followed by a Study Drug-Free Period

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events (TEAEs)
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
Incidence of Treatment-Emergent AEs (TEAEs) leading to study withdrawal
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
Incidence of Treatment-Emergent Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
Partial seizure frequency per 28 days during the 12-week Treatment Period
Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.

Secondary Outcome Measures

50% responder rate based on percent change in partial seizure frequency per 28 days from Baseline to the 12-week Treatment Period
Responders are those subjects with at least 50% reduction from Baseline to the 12-week Treatment Period in partial seizure frequency per 28 days
Percent change in partial seizure frequency per 28 days from Baseline to the 12-week Treatment Period
Calculated as 28-day seizure frequency during the Treatment Period - 28-day seizure frequency during the Baseline Period, divided by the 28-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial seizure frequency from Baseline to the Treatment Period.
Categorized percent change in partial seizures frequency per 28 days from Baseline to the 12-week Treatment Period
Calculated as 28-day seizure frequency during the Treatment Period - 28-day seizure frequency during the Baseline Period, divided by the 28-day seizure frequency during the Baseline Period with this quantity multiplied by 100.
All seizure frequency (partial, generalized, and unclassified epileptic seizures) per 28 days during the 12-week Treatment Period
There are three types of epileptic seizures: Partial epileptic seizures (Type I), Generalized epileptic seizures (Type II) and unclassified epileptic seizures (Type III).
Seizure freedom (partial, all epileptic seizure) during the 12-week Treatment Period
A subject was considered seizure free, if no seizure was reported during the 12-week Treatment Period.
Time to 1st partial seizure during the 12-week Treatment Period
Number of days to first seizure after Baseline.
Time to 5th partial seizure during the 12-week Treatment Period
Number of days to fifth seizure after Baseline.
Time to 10th partial seizure during the 12-week Treatment Period
Number of days to tenth seizure after Baseline.
Brivaracetam plasma levels
Blood samples will be collected at indicated time points to determine the brivaracetam plasma concentration.

Full Information

First Posted
February 28, 2017
Last Updated
October 6, 2022
Sponsor
UCB Biopharma SRL
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1. Study Identification

Unique Protocol Identification Number
NCT03083665
Brief Title
A Study to Evaluate the Efficacy and Safety of Brivaracetam in Study Participants (>=16 to 80 Years of Age) With Epilepsy
Official Title
A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study to Evaluate the Efficacy and Safety of Adjunctive Brivaracetam in Subjects (>=16 to 80 Years of Age) With Partial Seizures With or Without Secondary Generalization
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
August 22, 2017 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Biopharma SRL

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to evaluate the efficacy of brivaracetam (BRV) compared to placebo (PBO) as adjunctive treatment in subjects (>=16 to 80 years of age) with partial seizures with or without secondary generalization despite current treatment with 1 or 2 concomitant antiepileptic drugs (AEDs) and to assess the safety and tolerability of BRV in subjects >= 16 years to 80 years of age.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Seizures With or Without Secondary Generalization, Epilepsy
Keywords
Epilepsy, Partial seizures with or without secondary generalization, Brivaracetam, Briviact

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
449 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
12 weeks Treatment Period: Subjects will receive Placebo 4 weeks Down-Titration Period: Subjects will receive Placebo
Arm Title
BRV 50 mg/day
Arm Type
Experimental
Arm Description
12 weeks Treatment Period: Subjects will receive BRV 50 mg/day - Subjects entering into the Long term follow up (LTFU) study or managed access program (MAP): 2 weeks Transition Period: Subjects will receive BRV 50 mg/day followed by LTFU or MAP: Subjects will receive BRV 100 mg/day - Subjects not entering into the LTFU study or MAP: 4 weeks Down-Titration Period: Subjects will receive BRV 25 mg/day for 1 week followed by Placebo for 3 weeks, followed by a Study Drug-Free Period
Arm Title
BRV 200 mg/day
Arm Type
Experimental
Arm Description
12 weeks Treatment Period: Subjects will receive BRV 200 mg/day - Subjects entering into the Long term follow up (LTFU) study or managed access program (MAP): 2 weeks Transition Period: Subjects will receive BRV 150 mg/day followed by LTFU or MAP: Subjects will receive BRV 100 mg/day - Subjects not entering into the LTFU study or MAP: 4 weeks Down-Titration Period: Subjects will receive BRV 150 mg/day for 1 week followed by BRV 100 mg/day for 1 week, followed by BRV 50 mg/day for 1 week, followed by BRV 25 mg/day for 1 week followed by a Study Drug-Free Period
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Pharmaceutical form: Film-coated tablets Route of administration: Oral use
Intervention Type
Drug
Intervention Name(s)
Brivaracetam
Other Intervention Name(s)
Briviact
Intervention Description
Pharmaceutical form: Film-coated tablets Concentration: 25 mg tablets and 50 mg tablets Route of administration: Oral use
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Description
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
Time Frame
From start of the Treatment Period (Week 2) until Safety Visit (up to Week 18)
Title
Incidence of Treatment-Emergent AEs (TEAEs) leading to study withdrawal
Description
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
Time Frame
From start of the Treatment Period (Week 2) until Safety Visit (up to Week 18)
Title
Incidence of Treatment-Emergent Serious Adverse Events (SAEs)
Description
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
Time Frame
From start of the Treatment Period (Week 2) until Safety Visit (up to Week 18)
Title
Partial seizure frequency per 28 days during the 12-week Treatment Period
Description
Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.
Time Frame
From Baseline to 12-weeks Treatement Period
Secondary Outcome Measure Information:
Title
50% responder rate based on percent change in partial seizure frequency per 28 days from Baseline to the 12-week Treatment Period
Description
Responders are those subjects with at least 50% reduction from Baseline to the 12-week Treatment Period in partial seizure frequency per 28 days
Time Frame
From Baseline to 12-week Treatment Period
Title
Percent change in partial seizure frequency per 28 days from Baseline to the 12-week Treatment Period
Description
Calculated as 28-day seizure frequency during the Treatment Period - 28-day seizure frequency during the Baseline Period, divided by the 28-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial seizure frequency from Baseline to the Treatment Period.
Time Frame
From Baseline to 12-week Treatment Period
Title
Categorized percent change in partial seizures frequency per 28 days from Baseline to the 12-week Treatment Period
Description
Calculated as 28-day seizure frequency during the Treatment Period - 28-day seizure frequency during the Baseline Period, divided by the 28-day seizure frequency during the Baseline Period with this quantity multiplied by 100.
Time Frame
From Baseline to 12-week Treatment Period
Title
All seizure frequency (partial, generalized, and unclassified epileptic seizures) per 28 days during the 12-week Treatment Period
Description
There are three types of epileptic seizures: Partial epileptic seizures (Type I), Generalized epileptic seizures (Type II) and unclassified epileptic seizures (Type III).
Time Frame
During the 12-week Treatment Period
Title
Seizure freedom (partial, all epileptic seizure) during the 12-week Treatment Period
Description
A subject was considered seizure free, if no seizure was reported during the 12-week Treatment Period.
Time Frame
During the 12-week Treatment Period
Title
Time to 1st partial seizure during the 12-week Treatment Period
Description
Number of days to first seizure after Baseline.
Time Frame
During the 12-week Treatment Period
Title
Time to 5th partial seizure during the 12-week Treatment Period
Description
Number of days to fifth seizure after Baseline.
Time Frame
During the 12-week Treatment Period
Title
Time to 10th partial seizure during the 12-week Treatment Period
Description
Number of days to tenth seizure after Baseline.
Time Frame
During the 12-week Treatment Period
Title
Brivaracetam plasma levels
Description
Blood samples will be collected at indicated time points to determine the brivaracetam plasma concentration.
Time Frame
Plasma samples will be collected in week 2, 4, 8, 12, 14.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects (male or female) from 16 to 80 years of age at Visit 1, both inclusive Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method Subjects having at least 8 partial seizures (according to the 1981 ILAE classification) during the 8-Week Baseline Period with at least 2 partial seizures during each 4-week interval of the Baseline Period Subjects having at least 2 partial seizures whether or not secondary generalization per month during the 3 months preceding Visit 1 Subjects uncontrolled while treated by 1 or 2 permitted concomitant antiepileptic drug [AED](s). Vagal Nerve Stimulation (VNS) is allowed and will be counted as a concomitant AED Exclusion Criteria: Subject has history or presence of status epilepticus during the year preceding Visit 1 or during Baseline Subject is currently treated with levetiracetam Subject has taken levetiracetam within 90 days prior to Visit 1
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
001 844 599 2273 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
Ep0083 905
City
Beijing
Country
China
Facility Name
Ep0083 906
City
Beijing
Country
China
Facility Name
Ep0083 907
City
Changchun
Country
China
Facility Name
Ep0083 901
City
Chengdu
Country
China
Facility Name
Ep0083 902
City
Guangzhou
Country
China
Facility Name
Ep0083 909
City
Guangzhou
Country
China
Facility Name
Ep0083 917
City
Guangzhou
Country
China
Facility Name
Ep0083 920
City
Guangzhou
Country
China
Facility Name
Ep0083 922
City
Guangzhou
Country
China
Facility Name
Ep0083 924
City
Guangzhou
Country
China
Facility Name
Ep0083 912
City
Hangzhou
Country
China
Facility Name
Ep0083 908
City
Lanzhou
Country
China
Facility Name
Ep0083 921
City
Nanchang
Country
China
Facility Name
Ep0083 926
City
Pingxiang
Country
China
Facility Name
Ep0083 910
City
Shijiazhuang
Country
China
Facility Name
Ep0083 925
City
Suzhou
Country
China
Facility Name
Ep0083 913
City
Wenzhou
Country
China
Facility Name
Ep0083 927
City
Xi'an
Country
China
Facility Name
Ep0083 930
City
Xinxiang
Country
China
Facility Name
Ep0083 916
City
Yinchuan
Country
China
Facility Name
Ep0083 918
City
Zhanjiang
Country
China
Facility Name
Ep0083 904
City
Zhengzhou
Country
China
Facility Name
Ep0083 923
City
Zunyi
Country
China
Facility Name
Ep0083 148
City
Adachi-ku
Country
Japan
Facility Name
Ep0083 116
City
Asaka
Country
Japan
Facility Name
Ep0083 126
City
Bunkyo-ku
Country
Japan
Facility Name
Ep0083 127
City
Bunkyo-ku
Country
Japan
Facility Name
Ep0083 146
City
Chiba-shi
Country
Japan
Facility Name
Ep0083 122
City
Hachinohe
Country
Japan
Facility Name
Ep0083 111
City
Hamamatsu
Country
Japan
Facility Name
Ep0083 141
City
Higashisonogi-gun Kawatana-cho
Country
Japan
Facility Name
Ep0083 110
City
Hiroshima
Country
Japan
Facility Name
Ep0083 121
City
Itami
Country
Japan
Facility Name
Ep0083 102
City
Kagoshima
Country
Japan
Facility Name
Ep0083 142
City
Kamakura
Country
Japan
Facility Name
Ep0083 140
City
Kawasaki
Country
Japan
Facility Name
Ep0083 123
City
Kodaira
Country
Japan
Facility Name
Ep0083 115
City
Kokubunji
Country
Japan
Facility Name
Ep0083 132
City
Koriyama
Country
Japan
Facility Name
Ep0083 112
City
Koshi
Country
Japan
Facility Name
Ep0083 128
City
Kurume
Country
Japan
Facility Name
Ep0083 124
City
Kyoto
Country
Japan
Facility Name
Ep0083 147
City
Kyoto
Country
Japan
Facility Name
Ep0083 105
City
Nagakute
Country
Japan
Facility Name
Ep0083 118
City
Nagoya
Country
Japan
Facility Name
Ep0083 136
City
Nagoya
Country
Japan
Facility Name
Ep0083 117
City
Nara
Country
Japan
Facility Name
Ep0083 129
City
Neyagawa
Country
Japan
Facility Name
Ep0083 106
City
Niigata
Country
Japan
Facility Name
Ep0083 114
City
Saitama
Country
Japan
Facility Name
Ep0083 101
City
Sapporo
Country
Japan
Facility Name
Ep0083 103
City
Sendai
Country
Japan
Facility Name
Ep0083 144
City
Shinjuku-ku
Country
Japan
Facility Name
Ep0083 104
City
Shizuoka
Country
Japan
Facility Name
Ep0083 108
City
Suita
Country
Japan
Facility Name
Ep0083 137
City
Suita
Country
Japan
Facility Name
Ep0083 138
City
Tsukuba
Country
Japan
Facility Name
Ep0083 133
City
Ushiku
Country
Japan
Facility Name
Ep0083 109
City
Yamagata
Country
Japan
Facility Name
Ep0083 120
City
Yokohama
Country
Japan
Facility Name
Ep0083 150
City
Yokohama
Country
Japan
Facility Name
Ep0083 130
City
Ôsaka
Country
Japan
Facility Name
Ep0083 131
City
Ōtsu
Country
Japan
Facility Name
Ep0083 207
City
Kota Bharu
Country
Malaysia
Facility Name
Ep0083 201
City
Kuala Lumpur
Country
Malaysia
Facility Name
Ep0083 206
City
Kuala Terengganu
Country
Malaysia
Facility Name
Ep0083 204
City
Kuching
Country
Malaysia
Facility Name
Ep0083 209
City
Miri
Country
Malaysia
Facility Name
Ep0083 202
City
Perai
Country
Malaysia
Facility Name
Ep0083 208
City
Pulau Pinang
Country
Malaysia
Facility Name
Ep0083 203
City
Sungai Buloh
Country
Malaysia
Facility Name
Ep0083 303
City
Cebu City
Country
Philippines
Facility Name
Ep0083 304
City
Cebu City
Country
Philippines
Facility Name
Ep0083 306
City
Davao City
Country
Philippines
Facility Name
Ep0083 307
City
Iloilo City
Country
Philippines
Facility Name
Ep0083 301
City
Manila
Country
Philippines
Facility Name
Ep0083 302
City
Manila
Country
Philippines
Facility Name
Ep0083 310
City
Manila
Country
Philippines
Facility Name
Ep0083 309
City
Quezon City
Country
Philippines
Facility Name
Ep0083 401
City
Singapore
Country
Singapore
Facility Name
Ep0083 402
City
Singapore
Country
Singapore
Facility Name
Ep0083 502
City
Chiayi City
Country
Taiwan
Facility Name
Ep0083 505
City
Kaohsiung
Country
Taiwan
Facility Name
Ep0083 504
City
Taichung City
Country
Taiwan
Facility Name
Ep0083 503
City
Taichung
Country
Taiwan
Facility Name
Ep0083 501
City
Tainan
Country
Taiwan
Facility Name
Ep0083 602
City
Bangkok
Country
Thailand
Facility Name
Ep0083 605
City
Bangkok
Country
Thailand
Facility Name
Ep0083 606
City
Bangkok
Country
Thailand
Facility Name
Ep0083 607
City
Bangkok
Country
Thailand
Facility Name
Ep0083 609
City
Bangkok
Country
Thailand
Facility Name
Ep0083 601
City
Khon Kaen
Country
Thailand
Facility Name
Ep0083 603
City
Muang
Country
Thailand
Facility Name
Ep0083 608
City
Muang
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
IPD Sharing Time Frame
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
IPD Sharing Access Criteria
Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
IPD Sharing URL
https://vivli.org/

Learn more about this trial

A Study to Evaluate the Efficacy and Safety of Brivaracetam in Study Participants (>=16 to 80 Years of Age) With Epilepsy

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