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

NCT03250377 | Completed Phase 3 Results

• 1 other identifier: EP0085
• Study Type: interventional
• Target: 207
• Locations: 2 countries
• Sites: 59

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.

Conditions

Partial Seizures With or Without Secondary Generalization; Epilepsy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)

  An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent AEs (TEAEs) were defined as AEs that had onset on or after the day of first BRV dose in EP0085 study.

  From Baseline until end of the safety follow up (up to 88.5 months)

Secondary Outcomes (10)

• Percent Change in Partial Seizure Frequency (PSF) Per 28 Days From Baseline of EP0083 or N01358 to the Evaluation Period for Rollover Study Participants

  Baseline of EP0083 or N01358 and up to 84 months of Evaluation Period

• 50 Percent (%) Responder Rate in Partial Seizure Frequency Per 28 Days From Baseline of EP0083 or N01358 to the Evaluation Period for Rollover Study Participants

  Baseline of EP0083 or N01358 and up to 84 months of Evaluation Period

• Percent Change in Partial Seizure Frequency Per 28 Days From Baseline of Directly Enrolled Study Participants to the Evaluation Period

  Baseline (8 weeks prior to BRV administration), up to 39 months of Evaluation Period

• 50 % Responder Rate in Partial Seizure Frequency Per 28 Days Over the Evaluation Period for Directly Enrolled Study Participants

  Baseline (8 weeks prior to BRV administration), up to 39 months of Evaluation 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 Rollover Study Participants

  During the Evaluation Period (up to 84 months)

Study Arms (1)

Brivaracetam

EXPERIMENTAL

Subjects randomized to this arm will receive open-label Brivaracetam

Drug: Brivaracetam

Interventions

Brivaracetam DRUG

* Pharmaceutical form: Film-coated tablet * Concentration: 25 mg and 50 mg * Route of administration: Oral use

Also known as: Briviact

Brivaracetam

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (59)

Ep0085 905

Beijing, China

Location

Ep0085 901

Chengdu, China

Location

Ep0085 902

Guangzhou, China

Location

Ep0085 909

Guangzhou, China

Location

Ep0085 917

Guangzhou, China

Location

Ep0085 920

Guangzhou, China

Location

Ep0085 924

Guangzhou, China

Location

Ep0085 912

Hangzhou, China

Location

Ep0085 908

Lanzhou, China

Location

Ep0085 921

Nanchang, China

Location

Ep0085 926

Pingxiang, China

Location

Ep0085 910

Shijiazhuang, China

Location

Ep0085 925

Suzhou, China

Location

Ep0085 913

Wenzhou, China

Location

Ep0085 930

Xinxiang, China

Location

Ep0085 916

Yinchuan, China

Location

Ep0085 918

Zhanjiang, China

Location

Ep0085 904

Zhengzhou, China

Location

Ep0085 923

Zunyi, China

Location

Ep0085 148

Adachi-ku, Japan

Location

Ep0085 116

Asaka, Japan

Location

Ep0085 126

Bunkyō City, Japan

Location

Ep0085 127

Bunkyō City, Japan

Location

Ep0085 122

Hachinohe, Japan

Location

Ep0085 111

Hamamatsu, Japan

Location

Ep0085 141

Higashisonogi-gun Kawatana-cho, Japan

Location

Ep0085 110

Hiroshima, Japan

Location

Ep0085 121

Itami, Japan

Location

Ep0085 102

Kagoshima, Japan

Location

Ep0085 142

Kamakura, Japan

Location

Ep0085 140

Kawasaki, Japan

Location

Ep0085 123

Kodaira, Japan

Location

Ep0085 115

Kokubunji, Japan

Location

Ep0085 132

Kōriyama, Japan

Location

Ep0085 112

Kōshi, Japan

Location

Ep0085 128

Kurume, Japan

Location

Ep0085 124

Kyoto, Japan

Location

Ep0085 147

Kyoto, Japan

Location

Ep0085 105

Nagakute, Japan

Location

Ep0085 118

Nagoya, Japan

Location

Ep0085 136

Nagoya, Japan

Location

Ep0085 117

Nara, Japan

Location

Ep0085 129

Neyagawa, Japan

Location

Ep0085 106

Niigata, Japan

Location

Ep0085 850

Osaka, Japan

Location

Ep0085 130

Ôsaka, Japan

Location

Ep0085 131

Ōtsu, Japan

Location

Ep0085 114

Saitama, Japan

Location

Ep0085 101

Sapporo, Japan

Location

Ep0085 103

Sendai, Japan

Location

Ep0085 144

Shinjuku-ku, Japan

Location

Ep0085 104

Shizuoka, Japan

Location

Ep0085 108

Suita, Japan

Location

Ep0085 137

Suita, Japan

Location

Ep0085 138

Tsukuba, Japan

Location

Ep0085 133

Ushiku, Japan

Location

Ep0085 109

Yamagata, Japan

Location

Ep0085 120

Yokohama, Japan

Location

Ep0085 150

Yokohama, Japan

Location

Related Publications (1)

• Fujimoto A, Qin B, Bourikas D, Dickson N, Moseley B, Sano T, Soma T, Sun W, Watanabe J, Zhou D, Inoue Y. Safety, Tolerability, and Efficacy of Adjunctive Brivaracetam in Japanese and Chinese Patients with Focal-Onset Seizures: Interim Analysis of a Phase 3 Open-Label Extension Trial. Adv Ther. 2025 Sep;42(9):4335-4349. doi: 10.1007/s12325-025-03253-0. Epub 2025 Jun 23.

  PMID: 40549270 DERIVED

MeSH Terms

Conditions

Epilepsy

Interventions

brivaracetam

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

001 844 599 2273

Study Officials

• UCB Cares

  001 844 599 2273 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: August 15, 2017
• Study Start: August 5, 2017
• Primary Completion: December 24, 2024
• Study Completion: December 24, 2024
• Last Updated: July 29, 2025
• Results First Posted: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

JP (40); CN (19)