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Antiepileptic drug

Brivaracetam for Brain Tumor

Phase < 1
Waitlist Available
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years with pathologic diagnosis of a supratentorial diffuse astrocytic or oligodendroglial tumor
Be older than 18 years old
Must not have
Patients who have experienced an epileptic seizure as the presenting symptom of their brain tumor
Patients who are unable to swallow a tablet
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a drug called brivaracetam is safe for people with brain tumors.

Who is the study for?
This trial is for adults over 18 with a specific type of brain tumor (diffuse astrocytic or oligodendroglial). Participants must be able to consent and not have had seizures before their diagnosis, nor can they be on seizure drugs. They should expect to live more than 6 months, not be pregnant, and have no severe liver or kidney disease.
What is being tested?
The study is testing the tolerability and safety of Brivaracetam, a medication potentially useful for patients with brain tumors. It aims to see if people can handle the drug without significant issues.
What are the potential side effects?
While the trial primarily assesses tolerability, potential side effects of Brivaracetam may include sleepiness, dizziness, fatigue, nausea and possibly mood changes or skin rashes based on its use in other conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 18 and have been diagnosed with a specific brain tumor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My first sign of a brain tumor was a seizure.
Select...
I cannot swallow pills.
Select...
My kidney function is severely reduced.
Select...
My liver tests are not more than 3 times the normal limit.
Select...
I have not had serious mental health issues requiring hospitalization in the last 2 years.
Select...
I had seizures or epilepsy before being diagnosed with my tumor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety of Brivaracetam
Secondary study objectives
Voluntariness for study participation

Side effects data

From 2022 Phase 3 trial • 449 Patients • NCT03083665
19%
Somnolence
14%
Dizziness
7%
Nasopharyngitis
5%
Upper respiratory tract infection
5%
Headache
1%
Miscarriage of partner
1%
Pyrexia
1%
Calculus ureteric
1%
Large intestine polyp
100%
80%
60%
40%
20%
0%
Study treatment Arm
BRV 200 mg/Day
Placebo
BRV 50 mg/Day
Placebo to OLTP BRV
BRV 50 mg/Day to OLTP BRV
BRV 200 mg/Day to OLTP BRV

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: ExperimentalExperimental Treatment1 Intervention
Brivaracetam at a dose of 50 mg twice daily for 6 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brivaracetam
2019
Completed Phase 3
~4500

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor
872 Previous Clinical Trials
550,061 Total Patients Enrolled

Media Library

Brivaracetam (Antiepileptic drug) Clinical Trial Eligibility Overview. Trial Name: NCT05029960 — Phase < 1
Brain Tumor Research Study Groups: Experimental
Brain Tumor Clinical Trial 2023: Brivaracetam Highlights & Side Effects. Trial Name: NCT05029960 — Phase < 1
Brivaracetam (Antiepileptic drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05029960 — Phase < 1
~6 spots leftby Aug 2025
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