Long-term Safety and Efficacy of Adjunctive Brivaracetam in Chinese Patients With Uncontrolled Focal Epilepsy

NCT07563634 | Completed Phase 3

• 1 other identifier: QF-Brivaracetam-POS-302
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, open-label, single-arm, long-term follow-up trial designed to evaluate the long-term safety of adjunctive brivaracetam 200 mg/day (100 mg twice daily) in patients with partial-onset seizures. Secondary objectives include assessing the sustained efficacy of long-term brivaracetam treatment. Subjects who completed the 12-week maintenance phase of the preceding QF-Brivaracetam-POS-301 trial (regardless of prior treatment assignment to brivaracetam or placebo) are eligible to enroll, provided they are deemed to benefit from extended treatment, have not experienced intolerable drug-related adverse events, and are willing to continue brivaracetam therapy. All enrolled patients will receive open-label brivaracetam 200 mg/day (100 mg twice daily). Dose adjustments are permitted based on seizure control and tolerability, with a maximum dose of 200 mg/day. Concomitant antiepileptic drugs (AEDs) are allowed, including dose adjustments, initiation of new AEDs, or discontinuation of existing AEDs. The trial consists of four phases: a 1-week screening/lead-in phase, an extended treatment period, a 3-week dose tapering phase, and a 30-day safety follow-up period. During the extended treatment phase, study visits occur at Weeks 4, 12, 24, 36, and 52, followed by in-person visits every 6 months and telephone visits every 3 months thereafter. Unscheduled visits are allowed for adverse events or worsening seizure control. The dose tapering phase, which is optional, involves gradual discontinuation of brivaracetam over 3 weeks, or adjusted per the investigator's clinical judgment. The safety follow-up phase occurs 30 days after the last dose of study drug.

Conditions

Epilepsy, Focal

Outcome Measures

Primary Outcomes (3)

• Treatment Emergent Adverse Event (TEAE) Incidence Rate

  Proportion of subjects with at least one treatment-emergent adverse event (TEAE) during

  baseline,Weeks 4, 12, 24, 36, 52, and up to 2years

• Subject Discontinuation Rate Due to Adverse Events (AEs)

  Proportion of subjects who permanently discontinue study treatment due to an adverse event

  baseline,Weeks 4, 12, 24, 36, 52, and up to 2years

• Serious Adverse Event (SAE) Incidence Rate

  Proportion of subjects who experience at least one serious adverse event (SAE) during the extended treatment period

  baseline,Weeks 4, 12, 24, 36, 52, and up to 2years

Secondary Outcomes (3)

• Partial-Onset Seizure (POS, Type 1) Frequency per 28 Days

  baseline,Weeks 4, 12, 24, 36, 52, and up to 2years

• Change in Partial-Onset Seizure (POS, Type 1) Frequency per 28 Days

  baseline,Weeks 4, 12, 24, 36, 52, and up to 2years

• Responder Rates (50%, 75%, 90%) for Partial-Onset Seizure (POS, Type 1) Frequency

  baseline,Weeks 4, 12, 24, 36, 52, and up to 2years

Study Arms (1)

Brivaracetam Extended Treatment Arm

EXPERIMENTAL

All enrolled subjects receive open-label brivaracetam tablets as extended treatment. The initial dose is 200 mg/day (100 mg twice daily, oral administration). Dose adjustments are allowed based on seizure control and tolerability, with a maximum dose not exceeding 200 mg/day. Concomitant antiepileptic drugs are permitted, including dose adjustments, initiation of new AEDs, or discontinuation of existing AEDs.

Drug: Brivaracetam

Interventions

Brivaracetam DRUG

Brivaracetam tablets, oral administration, initial dose 200 mg/day (100 mg twice daily). Dose adjustments are allowed based on clinical response and tolerability, with a maximum dose not exceeding 200 mg/day.

Brivaracetam Extended Treatment Arm

Eligibility Criteria

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

You may qualify if:

• Able to understand and voluntarily sign the written informed consent form for this extension trial.
• Considered reliable by the investigator and capable of complying with the study protocol, including completing seizure diaries, attending study visits, and adhering to treatment.
• Completed the 12-week double-blind maintenance treatment period of the preceding QF-Brivaracetam-POS-301 trial.
• Judged by the investigator to be likely to benefit from long-term treatment with brivaracetam.
• Female subjects of childbearing potential must have a negative pregnancy test within 7 days prior to the first study drug administration and agree to use a medically acceptable method of contraception during the trial and for 3 months after the last dose of study drug. Male subjects with partners of childbearing potential must agree to use effective contraception during the trial and for 3 months after the last dose of study drug.

You may not qualify if:

• Known hypersensitivity to brivaracetam, levetiracetam, or other pyrrolidine derivatives; or history of multiple severe allergies.
• Any medical or psychiatric condition that, in the investigator's opinion, may jeopardize or impair the subject's ability to participate in the trial; or clinically significant abnormal laboratory values including: calculated CrCL \< 30 mL/min (Cockcroft-Gault formula), platelets \< 80×10\^9/L, neutrophils \< 1.8×10\^9/L, ALT/AST/ALP \> 2×ULN, or GGT \> 3×ULN.
• QTc interval \> 450 ms on 12-lead ECG, confirmed by repeat testing (average of 3 measurements remains \> 450 ms).
• Female subjects who are pregnant or breastfeeding.
• History of suicide attempts (including actual attempts, interrupted attempts, aborted attempts, or preparatory acts/behavior) or current suicidal ideation, as assessed by the C-SSRS scale.
• Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in this trial.

Sponsors & Collaborators

• Jiangxi Qingfeng Pharmaceutical Co. Ltd.: lead

Study Sites (1)

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

MeSH Terms

Conditions

Epilepsies, Partial

Interventions

brivaracetam

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Zhen Hong, MD

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label study; no masking is performed.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: May 4, 2026
• Study Start: February 7, 2021
• Primary Completion: May 21, 2024
• Study Completion: April 29, 2025
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)