Brain tumor drug trial fizzles: only 3 patients enrolled
NCT ID NCT05029960
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tested whether brivaracetam, a seizure medication, is safe for people with diffuse gliomas (a type of brain tumor). Only 3 participants were enrolled before the study was terminated. The main goal was to track side effects, not to measure tumor shrinkage or survival. Because it ended early, no strong conclusions can be drawn.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Brivaracetam (a seizure drug)
- What this could lead to
- If it works, this could point toward a way to manage brain tumor symptoms safely.
- What could go wrong
- This was a very early, tiny trial (only 3 people) that ended early. It cannot prove effectiveness, and the drug may cause side effects.
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
-
Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
3 people
The number who actually took part.
- Started
-
May 2022
- Finished
-
May 2024
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
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: * Age ≥ 18 years with pathologic diagnosis of a supratentorial diffuse astrocytic or oligodendroglial tumor * Patients must be able to provide informed consent Exclusion Criteria: * A pre-existing seizure disorder or epilepsy syndrome prior to tumor diagnosis * Active maintenance therapy with an antiepileptic seizure drug (AED) prior to diagnosis of tumor * Patients who have experienced an epileptic seizure as the presenting symptom of their brain tumor * Predicted life expectancy of less than 6 months from the time of screening * Pregnancy * Patients with clinically significant hepatic disease (elevated aminotransferases \[bilirubin, alkaline phosphatase\] \> 3 times upper limit normal) * Patients with stage 4 or greater renal disease (GFR \<30 mL/min/1.73 m2) * Patients who are unable to swallow a tablet * Patients with active suicidal ideation or a history of suicide attempt or other serious psychiatric disorder having required hospitalization within the previous 2 years.
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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
-
University of Rochester Medical Center
Rochester, New York, 14642, United States
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