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Epilepsy patients get continued access to brivaracetam through compassionate program
NCT ID NCT03532516
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This program provides brivaracetam (Briviact) to epilepsy patients who were already taking it in earlier studies, bridging the gap until the drug is commercially available. Patients continue their individual doses, up to 200 mg per day, with adjustments based on seizure control and side effects. Only patients who have already shown benefit and whose doctors agree that other treatments may not be suitable are eligible.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Brivaracetam (Briviact)
- What this could lead to
- If successful, this program could provide continuous seizure control for epilepsy patients who have already benefited from brivaracetam in prior studies.
- What could go wrong
- This is a compassionate use program, not a formal trial, so results are not systematically collected. It only includes patients already on the drug, so benefits may not apply to others.
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.
- 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 years and older
- Sex
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Anyone
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients with epilepsy who are participating in Brivaracetam (BRV) studies N01125, N01199, N01372, N01379 or N01315 * Patients for whom the treating physician believes there is a continued benefit from the long-term administration of BRV and other anti-epileptic therapies might not be suitable for the patient * Female patients without childbearing potential are eligible * Female patients with childbearing potential are eligible if they use a medically accepted contraceptive method for the duration of the Compassionate Use Program (CUP) participation. The patient must understand the consequences and potential risks of inadequately protected sexual activity, be educated about and understand the proper use of contraceptive methods, and inform the treating physician of any potential change in status * Patient is considered reliable and capable of adhering to medication intake. * Patient is informed of the details of this CUP, is given ample time and opportunity to ask questions and consider his/her participation in this CUP, and the patient or the legally authorized representative (LAR) has provided verbal consent to participate, and, if required under local regulations, has given written informed consent Exclusion Criteria: * Severe medical, neurological and psychiatric disorders, including current suicidal ideation or behavior, or laboratory values which may have an impact on the safety of the patient, as determined by the treating physician * Poor compliance with medication intake in the previous BRV study * Participation in any clinical study of another investigation drug or device during the CUP * Pregnant or lactating woman
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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.
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