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

2026년 4월 29일 업데이트: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

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

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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

Background and Rationale： Epilepsy is a neurological disorder characterized by recurrent, unprovoked seizures resulting from abnormal, excessive, or synchronous neuronal activity in the brain. Clinical manifestations include myoclonus, sudden interruption of psychomotor activity, loss of consciousness, sensory abnormalities, and emotional or psychomotor disturbances. In severe cases, sudden loss of consciousness with tonic-clonic convulsions may occur, accompanied by screaming, cyanosis, foaming at the mouth, and pupillary dilation. Status epilepticus, characterized by continuous seizure activity, can be life-threatening.

Brivaracetam tablets are a derivative of the second-generation antiepileptic drug levetiracetam, with a propyl group attached to the 4-position carbon of the pyrrolidine ring. Brivaracetam exerts its antiepileptic effect by binding to synaptic vesicle protein 2A (SV2A) in presynaptic nerve terminals, with 15 to 30 times higher affinity than levetiracetam. Its favorable lipophilicity enables efficient blood-brain barrier penetration, significantly enhancing antiepileptic activity. Brivaracetam demonstrates high bioavailability, rapid oral absorption, and favorable pharmacokinetic and safety profiles. Its excellent central nervous system tolerability represents a key advantage over other antiepileptic drugs.

Study Rationale： This extension study is designed to evaluate the long-term safety and sustained efficacy of adjunctive brivaracetam in Chinese patients with uncontrolled focal epilepsy who have completed the preceding QF-Brivaracetam-POS-301 trial. Eligible subjects are those who, in the investigator's judgment, may benefit from continued brivaracetam treatment, have not experienced intolerable drug-related adverse events, and are willing to continue brivaracetam therapy during the extension phase.

연구 유형

중재적

등록 (실제)

141

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 중국
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, 중국, 200040
        • Huashan Hospital, Fudan University

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Brivaracetam Extended Treatment Arm
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.
의약품: Brivaracetam
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Treatment Emergent Adverse Event (TEAE) Incidence Rate
기간: baseline,Weeks 4, 12, 24, 36, 52, and up to 2years
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)
기간: baseline,Weeks 4, 12, 24, 36, 52, and up to 2years
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
기간: baseline,Weeks 4, 12, 24, 36, 52, and up to 2years
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

2차 결과 측정

결과 측정
측정값 설명
기간
Partial-Onset Seizure (POS, Type 1) Frequency per 28 Days
기간: baseline,Weeks 4, 12, 24, 36, 52, and up to 2years
Partial-onset seizure frequency per 28 days, calculated as (total number of partial-onset seizures) / (number of non-missing seizure diary days during treatment) × 28.
baseline,Weeks 4, 12, 24, 36, 52, and up to 2years
Change in Partial-Onset Seizure (POS, Type 1) Frequency per 28 Days
기간: baseline,Weeks 4, 12, 24, 36, 52, and up to 2years
Change from baseline in partial-onset seizure frequency per 28 days, calculated as (baseline value - value at each assessment window) / baseline value × 100%
baseline,Weeks 4, 12, 24, 36, 52, and up to 2years
Responder Rates (50%, 75%, 90%) for Partial-Onset Seizure (POS, Type 1) Frequency
기간: baseline,Weeks 4, 12, 24, 36, 52, and up to 2years
Proportion of subjects with ≥50%, ≥75%, and ≥90% reduction in partial-onset seizure frequency compared to the baseline period of the preceding QF-Brivaracetam-POS-301 trial
baseline,Weeks 4, 12, 24, 36, 52, and up to 2years

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Jiangxi Qingfeng Pharmaceutical Co. Ltd.

수사관

  • 수석 연구원: Zhen Hong, MD, Huashan Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2021년 2월 7일

기본 완료 (실제)

2024년 5월 21일

연구 완료 (실제)

2025년 4월 29일

연구 등록 날짜

최초 제출

2026년 4월 17일

QC 기준을 충족하는 최초 제출

2026년 4월 29일

처음 게시됨 (실제)

2026년 5월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 4월 29일

마지막으로 확인됨

2026년 4월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • QF-Brivaracetam-POS-302

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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