A Phase 3 interventional study of Brivaracetam in Epilepsy, Focal, sponsored by Jiangxi Qingfeng Pharmaceutical Co. Ltd.. Completed at 1 site in China. Open to participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-04.
Sponsored by Jiangxi Qingfeng Pharmaceutical Co. Ltd. · Phase 3, Interventional, and Treatment
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.
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.
254 studies on the registry are indexed under Epilepsies, Partial; 48 are open to participants now.
This study's enrollment of 141 is above the median of 87 across 197 interventional studies indexed under Epilepsies, Partial.
Browse Epilepsies, Partial studies →Jiangxi Qingfeng Pharmaceutical Co. Ltd. is the lead sponsor of 32 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
Treatment Emergent Adverse Event (TEAE) Incidence Rate
Proportion of subjects with at least one treatment-emergent adverse event (TEAE) during
Time frame: 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
Time frame: 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
Time frame: baseline,Weeks 4, 12, 24, 36, 52, and up to 2years
Partial-Onset Seizure (POS, Type 1) Frequency per 28 Days
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.
Time frame: baseline,Weeks 4, 12, 24, 36, 52, and up to 2years
Change in Partial-Onset Seizure (POS, Type 1) Frequency per 28 Days
Change from baseline in partial-onset seizure frequency per 28 days, calculated as (baseline value - value at each assessment window) / baseline value × 100%
Time frame: baseline,Weeks 4, 12, 24, 36, 52, and up to 2years
Responder Rates (50%, 75%, 90%) for Partial-Onset Seizure (POS, Type 1) Frequency
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
Time frame: baseline,Weeks 4, 12, 24, 36, 52, and up to 2years
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Jiangxi Qingfeng Pharmaceutical Co. Ltd.