New epilepsy drug shows promise for long-term seizure control
NCT ID NCT07563634
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at the long-term safety of brivaracetam, a drug added to existing epilepsy treatments for people with uncontrolled focal seizures. 141 Chinese adults who completed a prior trial took brivaracetam for up to a year or more. Researchers tracked side effects and seizure frequency to see if the drug remains safe and effective over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- brivaracetam
- What this could lead to
- If successful, this could confirm brivaracetam as a safe and effective long-term add-on treatment for people with focal epilepsy that isn't controlled by other medications.
- What could go wrong
- This is an open-label study with no placebo group, so results may be less reliable. Side effects like dizziness or drowsiness are possible, and not everyone may benefit.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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141 people
The number who actually took part.
- Started
-
Feb 2021
- Finished
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Apr 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
16 to 65 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.