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

29 kwietnia 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

141

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Lek: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Treatment Emergent Adverse Event (TEAE) Incidence Rate
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Partial-Onset Seizure (POS, Type 1) Frequency per 28 Days
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Śledczy

  • Główny śledczy: Zhen Hong, MD, Huashan Hospital

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

7 lutego 2021

Zakończenie podstawowe (Rzeczywisty)

21 maja 2024

Ukończenie studiów (Rzeczywisty)

29 kwietnia 2025

Daty rejestracji na studia

Pierwszy przesłany

17 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

29 kwietnia 2026

Pierwszy wysłany (Rzeczywisty)

4 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

4 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

29 kwietnia 2026

Ostatnia weryfikacja

1 kwietnia 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • QF-Brivaracetam-POS-302

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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