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A Study to Test the Safety/ Efficacy of Brivaracetam (BRV) Used as Adjunctive Treatment in Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization

Primary Purpose

Partial Seizures With or Without Secondary Generalization, Epilepsy

Status
Enrolling by invitation
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
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 Brivaracetam, Epilepsy, Partial seizures with or without secondary generalization, Briviact

Eligibility Criteria

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

Inclusion Criteria:

  • Male/female subject from 16 years of age or older. Subjects who are not legal adults may only be included where legally permitted and ethically accepted
  • Subject completed the Treatment Period and Transition Period of EP0083 or is ongoing in N01379 sites in Japan
  • Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method

Exclusion Criteria:

  • Subject has developed hypersensitivity to any components of the investigational medicinal product (IMP) or comparative drugs as stated in this protocol during the course of the core study
  • Severe medical, neurological or 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 BRV studies
  • Planned participation in any other clinical study of another investigational drug or device during this study
  • Pregnant or lactating woman
  • Any medical condition which, in the Investigator's opinion, warrants exclusion
  • Subject has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months
  • Subject has >2 x upper limit of normal (ULN) of any of the following at the Entry Visit (EV): alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >ULN total bilirubin (≥1.5x ULN total bilirubin if known Gilbert's syndrome)

Sites / Locations

  • Ep0085 905
  • Ep0085 901
  • Ep0085 902
  • Ep0085 909
  • Ep0085 917
  • Ep0085 920
  • Ep0085 924
  • Ep0085 912
  • Ep0085 908
  • Ep0085 921
  • Ep0085 926
  • Ep0085 910
  • Ep0085 925
  • Ep0085 913
  • Ep0085 930
  • Ep0085 916
  • Ep0085 918
  • Ep0085 904
  • Ep0085 923
  • Ep0085 148
  • Ep0085 116
  • Ep0085 126
  • Ep0085 127
  • Ep0085 122
  • Ep0085 111
  • Ep0085 141
  • Ep0085 110
  • Ep0085 121
  • Ep0085 102
  • Ep0085 142
  • Ep0085 140
  • Ep0085 123
  • Ep0085 115
  • Ep0085 132
  • Ep0085 112
  • Ep0085 128
  • Ep0085 124
  • Ep0085 147
  • Ep0085 105
  • Ep0085 118
  • Ep0085 136
  • Ep0085 117
  • Ep0085 129
  • Ep0085 106
  • Ep0085 850
  • Ep0085 114
  • Ep0085 101
  • Ep0085 103
  • Ep0085 144
  • Ep0085 104
  • Ep0085 108
  • Ep0085 137
  • Ep0085 138
  • Ep0085 133
  • Ep0085 109
  • Ep0085 120
  • Ep0085 150
  • Ep0085 130
  • Ep0085 131

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Brivaracetam

Arm Description

Subjects randomized to this arm will receive open-label Brivaracetam

Outcomes

Primary Outcome Measures

Percentage of study participants with 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.

Secondary Outcome Measures

Percent change in partial seizure frequency per 28 days from Baseline of EP0083 or N01358 to the Evaluation Period
The seizure frequency is calculated as number of seizures per 28 days. This evaluation will be done every 3 months of the Evaluation Period (by 3-month periods). Change in seizure frequency from Baseline of EP0083 (NCT03083665) or N01358 (NCT01261325) is calculated as the seizure frequency at the evaluation time point minus the seizure frequency at Baseline of EP0083 or N01358.
Responder rate in partial seizure frequency per 28 days over the Evaluation Period
The seizure frequency is calculated as number of seizures per 28 days. This evaluation will be done every 3 months of the Evaluation Period (by 3-month periods). A responder is defined as a subject with a >= 50% reduction in seizure frequency from the Baseline Period of EP0083 or N01358.
Percentage of participants continuously seizure-free for partial seizure and all seizure types (partial, generalized, and unclassified epileptic seizure) for at least 6 months during the Evaluation Period
A study participant was considered seizure free, if no seizure occurred during 6 consecutive months in the Evaluation Period.
Percentage of participants continuously seizure-free for partial seizure and all seizure types (partial, generalized, and unclassified epileptic seizure) for at least 12 months during the Evaluation Period
A study participant was considered seizure free, if no seizure occurred during 12 consecutive months in the Evaluation Period.
Percentage of participants continuously seizure-free for partial seizure and all seizure types during the Evaluation Period
A study participant was considered seizure free (partial, all epileptic seizure), if no seizure occurred during the Evaluation Period.
Percent change in partial seizure frequency per 28 days from Baseline of directly enrolled study participants to the Evaluation Period
The seizure frequency for directly enrolled participants is calculated as number of seizures per 28 days from 8 weeks prior to BRV administration. Change in seizure frequency is calculated as the seizure frequency at the evaluation time point minus the seizure frequency at Baseline of directly enrolled participants.
Responder rate in partial seizure frequency per 28 days over the Evaluation Period for directly enrolled study participants
The seizure frequency for directly enrolled participants is calculated as number of seizures per 28 days from 8 weeks prior to BRV administration. A responder is defined as a study participant with a >= 50% reduction in seizure frequency from the Baseline Period.
Percentage of participants continuously seizure-free for partial seizure and all seizure types (partial, generalized, and unclassified epileptic seizure) for at least 6 months during the Evaluation Period for directly enrolled study particpants
A study participant was considered seizure free, if no seizure occurred during 6 consecutive months in the Evaluation Period.
Percentage of participants continuously seizure-free for partial seizure and all seizure types (partial, generalized, and unclassified epileptic seizure) for at least 12 months during the Evaluation Period for directly enrolled study particpants
A study participant was considered seizure free, if no seizure occurred during 12 consecutive months in the Evaluation Period.
Percentage of participants continuously seizure-free for partial seizure and all seizure types during the Evaluation Period for directly enrolled study particpants
A study participant was considered seizure free (partial, all epileptic seizure), if no seizure occurred during the Evaluation Period.

Full Information

First Posted
July 31, 2017
Last Updated
May 18, 2023
Sponsor
UCB Biopharma SRL
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1. Study Identification

Unique Protocol Identification Number
NCT03250377
Brief Title
A Study to Test the Safety/ Efficacy of Brivaracetam (BRV) Used as Adjunctive Treatment in Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization
Official Title
An Open-Label, Multicenter, Follow-up Study to Evaluate the Long-Term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 5, 2017 (Actual)
Primary Completion Date
March 3, 2025 (Anticipated)
Study Completion Date
March 3, 2025 (Anticipated)

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 long-term safety and tolerability of Brivaracetam (BRV) in focal epilepsy subjects with partial seizures and to evaluate the maintenance of efficacy of BRV over time.

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
Brivaracetam, Epilepsy, Partial seizures with or without secondary generalization, Briviact

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Brivaracetam
Arm Type
Experimental
Arm Description
Subjects randomized to this arm will receive open-label Brivaracetam
Intervention Type
Drug
Intervention Name(s)
Brivaracetam
Other Intervention Name(s)
Briviact
Intervention Description
Pharmaceutical form: Film-coated tablet Concentration: 25 mg and 50 mg Route of administration: Oral use
Primary Outcome Measure Information:
Title
Percentage of study participants with 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 study entry until Final Visit (up to 70 months)
Secondary Outcome Measure Information:
Title
Percent change in partial seizure frequency per 28 days from Baseline of EP0083 or N01358 to the Evaluation Period
Description
The seizure frequency is calculated as number of seizures per 28 days. This evaluation will be done every 3 months of the Evaluation Period (by 3-month periods). Change in seizure frequency from Baseline of EP0083 (NCT03083665) or N01358 (NCT01261325) is calculated as the seizure frequency at the evaluation time point minus the seizure frequency at Baseline of EP0083 or N01358.
Time Frame
Baseline of EP0083 or N01358 and by 3-month periods over the Evaluation Period (up to 70 months)
Title
Responder rate in partial seizure frequency per 28 days over the Evaluation Period
Description
The seizure frequency is calculated as number of seizures per 28 days. This evaluation will be done every 3 months of the Evaluation Period (by 3-month periods). A responder is defined as a subject with a >= 50% reduction in seizure frequency from the Baseline Period of EP0083 or N01358.
Time Frame
Baseline of EP0083 or N01358 and by 3-month periods over the Evaluation Period (up to 70 months)
Title
Percentage of participants continuously seizure-free for partial seizure and all seizure types (partial, generalized, and unclassified epileptic seizure) for at least 6 months during the Evaluation Period
Description
A study participant was considered seizure free, if no seizure occurred during 6 consecutive months in the Evaluation Period.
Time Frame
During the Evaluation Period (up to 70 months)
Title
Percentage of participants continuously seizure-free for partial seizure and all seizure types (partial, generalized, and unclassified epileptic seizure) for at least 12 months during the Evaluation Period
Description
A study participant was considered seizure free, if no seizure occurred during 12 consecutive months in the Evaluation Period.
Time Frame
During the Evaluation Period (up to 70 months)
Title
Percentage of participants continuously seizure-free for partial seizure and all seizure types during the Evaluation Period
Description
A study participant was considered seizure free (partial, all epileptic seizure), if no seizure occurred during the Evaluation Period.
Time Frame
During the Evaluation Period (up to 70 months)
Title
Percent change in partial seizure frequency per 28 days from Baseline of directly enrolled study participants to the Evaluation Period
Description
The seizure frequency for directly enrolled participants is calculated as number of seizures per 28 days from 8 weeks prior to BRV administration. Change in seizure frequency is calculated as the seizure frequency at the evaluation time point minus the seizure frequency at Baseline of directly enrolled participants.
Time Frame
Baseline from 8 weeks prior to BRV administration over the Evaluation Period (up to 70 months)
Title
Responder rate in partial seizure frequency per 28 days over the Evaluation Period for directly enrolled study participants
Description
The seizure frequency for directly enrolled participants is calculated as number of seizures per 28 days from 8 weeks prior to BRV administration. A responder is defined as a study participant with a >= 50% reduction in seizure frequency from the Baseline Period.
Time Frame
Baseline from 8 weeks prior to BRV administration over the Evaluation Period (up to 70 months)
Title
Percentage of participants continuously seizure-free for partial seizure and all seizure types (partial, generalized, and unclassified epileptic seizure) for at least 6 months during the Evaluation Period for directly enrolled study particpants
Description
A study participant was considered seizure free, if no seizure occurred during 6 consecutive months in the Evaluation Period.
Time Frame
During the Evaluation Period (up to 70 months)
Title
Percentage of participants continuously seizure-free for partial seizure and all seizure types (partial, generalized, and unclassified epileptic seizure) for at least 12 months during the Evaluation Period for directly enrolled study particpants
Description
A study participant was considered seizure free, if no seizure occurred during 12 consecutive months in the Evaluation Period.
Time Frame
During the Evaluation Period (up to 70 months)
Title
Percentage of participants continuously seizure-free for partial seizure and all seizure types during the Evaluation Period for directly enrolled study particpants
Description
A study participant was considered seizure free (partial, all epileptic seizure), if no seizure occurred during the Evaluation Period.
Time Frame
During the Evaluation Period (up to 70 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male/female study participant from 16 years of age or older. Study participant who are not legal adults may only be included where legally permitted and ethically accepted Study participant completed the Treatment Period and Transition Period of EP0083 or is ongoing in N01379 sites in Japan Female study participants with childbearing potential are eligible if they use a medically accepted contraceptive method Inclusion Criteria for directly enrollers only: Study participant has 1 to <8 partial seizures (according to the 1981 International League Against Epilepsy (ILAE) classification) during the 8 weeks prior to brivaracetam (BRV) administration Exclusion Criteria: Study participant has developed hypersensitivity to any components of the investigational medicinal product (IMP) or comparative drugs as stated in this protocol during the course of the core study Severe medical, neurological or psychiatric disorders, or laboratory values which may have an impact on the safety of the study participant Poor compliance with the visit schedule or medication intake in the previous BRV studies Planned participation in any other clinical study of another investigational drug or device during this study Pregnant or lactating woman Any medical condition which, in the Investigator's opinion, warrants exclusion Study participant has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months Study participant has >2 x upper limit of normal (ULN) of any of the following at the Entry Visit (EV): alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >ULN total bilirubin (≥1.5x ULN total bilirubin if known Gilbert's syndrome)
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
Ep0085 905
City
Beijing
Country
China
Facility Name
Ep0085 901
City
Chengdu
Country
China
Facility Name
Ep0085 902
City
Guangzhou
Country
China
Facility Name
Ep0085 909
City
Guangzhou
Country
China
Facility Name
Ep0085 917
City
Guangzhou
Country
China
Facility Name
Ep0085 920
City
Guangzhou
Country
China
Facility Name
Ep0085 924
City
Guangzhou
Country
China
Facility Name
Ep0085 912
City
Hangzhou
Country
China
Facility Name
Ep0085 908
City
Lanzhou
Country
China
Facility Name
Ep0085 921
City
Nanchang
Country
China
Facility Name
Ep0085 926
City
Pingxiang
Country
China
Facility Name
Ep0085 910
City
Shijiazhuang
Country
China
Facility Name
Ep0085 925
City
Suzhou
Country
China
Facility Name
Ep0085 913
City
Wenzhou
Country
China
Facility Name
Ep0085 930
City
Xinxiang
Country
China
Facility Name
Ep0085 916
City
Yinchuan
Country
China
Facility Name
Ep0085 918
City
Zhanjiang
Country
China
Facility Name
Ep0085 904
City
Zhengzhou
Country
China
Facility Name
Ep0085 923
City
Zunyi
Country
China
Facility Name
Ep0085 148
City
Adachi-ku
Country
Japan
Facility Name
Ep0085 116
City
Asaka
Country
Japan
Facility Name
Ep0085 126
City
Bunkyo-ku
Country
Japan
Facility Name
Ep0085 127
City
Bunkyo-ku
Country
Japan
Facility Name
Ep0085 122
City
Hachinohe
Country
Japan
Facility Name
Ep0085 111
City
Hamamatsu
Country
Japan
Facility Name
Ep0085 141
City
Higashisonogi-gun Kawatana-cho
Country
Japan
Facility Name
Ep0085 110
City
Hiroshima-shi
Country
Japan
Facility Name
Ep0085 121
City
Itami
Country
Japan
Facility Name
Ep0085 102
City
Kagoshima
Country
Japan
Facility Name
Ep0085 142
City
Kamakura
Country
Japan
Facility Name
Ep0085 140
City
Kawasaki
Country
Japan
Facility Name
Ep0085 123
City
Kodaira
Country
Japan
Facility Name
Ep0085 115
City
Kokubunji
Country
Japan
Facility Name
Ep0085 132
City
Koriyama
Country
Japan
Facility Name
Ep0085 112
City
Koshi
Country
Japan
Facility Name
Ep0085 128
City
Kurume
Country
Japan
Facility Name
Ep0085 124
City
Kyoto
Country
Japan
Facility Name
Ep0085 147
City
Kyoto
Country
Japan
Facility Name
Ep0085 105
City
Nagakute
Country
Japan
Facility Name
Ep0085 118
City
Nagoya
Country
Japan
Facility Name
Ep0085 136
City
Nagoya
Country
Japan
Facility Name
Ep0085 117
City
Nara
Country
Japan
Facility Name
Ep0085 129
City
Neyagawa
Country
Japan
Facility Name
Ep0085 106
City
Niigata
Country
Japan
Facility Name
Ep0085 850
City
Osaka
Country
Japan
Facility Name
Ep0085 114
City
Saitama
Country
Japan
Facility Name
Ep0085 101
City
Sapporo
Country
Japan
Facility Name
Ep0085 103
City
Sendai
Country
Japan
Facility Name
Ep0085 144
City
Shinjuku-ku
Country
Japan
Facility Name
Ep0085 104
City
Shizuoka
Country
Japan
Facility Name
Ep0085 108
City
Suita
Country
Japan
Facility Name
Ep0085 137
City
Suita
Country
Japan
Facility Name
Ep0085 138
City
Tsukuba
Country
Japan
Facility Name
Ep0085 133
City
Ushiku
Country
Japan
Facility Name
Ep0085 109
City
Yamagata
Country
Japan
Facility Name
Ep0085 120
City
Yokohama
Country
Japan
Facility Name
Ep0085 150
City
Yokohama
Country
Japan
Facility Name
Ep0085 130
City
Ôsaka
Country
Japan
Facility Name
Ep0085 131
City
Ōtsu
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study to Test the Safety/ Efficacy of Brivaracetam (BRV) Used as Adjunctive Treatment in Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization

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