NCT07563634CompletedPhase 3
Long-term Safety and Efficacy of Adjunctive Brivaracetam in Chinese Patients With Uncontrolled Focal Epilepsy
An Open-Label, Multicenter, Long-Term Follow-Up Study to Evaluate the Safety and Sustained Efficacy of Adjunctive Brivaracetam Tablets in Chinese Patients With Uncontrolled Focal Epilepsy
Source: ClinicalTrials.gov · Last updated 4 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 141 (actual)
- First submitted
- 17 Apr 2026
- Start date
- 7 Feb 2021
- Primary completion date
- 21 May 2024
- Lead sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.
- Diseases
- Epilepsy
- NCT number
- NCT07563634
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 141
- From 7 Feb 2021 to the primary completion date, 21 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known hypersensitivity to brivaracetam, levetiracetam, or other pyrrolidine derivatives; or history of multiple severe allergies.
- 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.
Lab values
- 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).
Other
- Female subjects who are pregnant or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 16 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Huashan Hospital, Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.