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Epilepsy patients get continued access to brivaracetam through compassionate program

NCT ID NCT03532516

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended) This study
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Anyone

Show 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

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