Brain TumorEarly Phase 1NCT05029960
Tolerability and Activity of Brivaracetam (BRV) in Patients With Diffuse Gliomas
A Early Phase 1 study testing Brivaracetam in people with Brain Tumor, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the study medication, brivaracetam, is tolerable and safe for patients with brain tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor
- What is being tested?
- Brivaracetam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2022to 9 May 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years with pathologic diagnosis of a supratentorial diffuse astrocytic or oligodendroglial tumor
- Patients must be able to provide informed consent
Who cannot join
- 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)
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
The purpose of this study is to determine whether the study medication, brivaracetam, is tolerable and safe for patients with brain tumors.
Read the detailed description
In this study, subjects will receive usual treatment for their brain tumor. In addition, they will be given brivaracetam at a dose of 50 mg twice daily.
- Conditions
- Brain Tumor
- Being tested
- Brivaracetam
- Keywords
- Brain Tumor, Brivaracetam, Epilepsy
- Medical subject headings
- Brain Neoplasms, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrivaracetamDrug
Dose of 50 mg twice daily for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Brivaracetam at a dose of 50 mg twice daily for 6 months Receives: Drug: Brivaracetam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Brivaracetam
Evaluate adverse events
Measured: 6 Months
Secondary outcomes (1)
Voluntariness for study participation
Number of people that declined to participate
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start17 May 2022
- Primary completion9 May 2024
- Study completion9 May 2024
Why it stopped: lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Wychowski, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05029960
- Sponsor's protocol ID
- UBRT21074
- Status last verified
- Jun 2026
- First submitted
- 25 Aug 2021
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerability and Activity of Brivaracetam (BRV) in Patients With Diffuse Gliomas
- ClinicalTrials.gov ID
- NCT05029960
- Acronym / sponsor ID
- UBRT21074
- Conditions
- Brain Tumor
- Keywords
- Brain Tumor, Brivaracetam, Epilepsy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of enrollment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 17 May 2022 (actual)
- Primary completion
- 9 May 2024 (actual)
- Study completion
- 9 May 2024 (actual)
- First posted
- 1 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the study medication, brivaracetam, is tolerable and safe for patients with brain tumors.
Detailed description
In this study, subjects will receive usual treatment for their brain tumor. In addition, they will be given brivaracetam at a dose of 50 mg twice daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: BrivaracetamBrivaracetam at a dose of 50 mg twice daily for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years with pathologic diagnosis of a supratentorial diffuse astrocytic or oligodendroglial tumor
- Patients must be able to provide informed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrivaracetamDose of 50 mg twice daily for 6 months | Drug | Experimental |
Primary outcome
Safety of Brivaracetam
Time frame: 6 Months
Evaluate adverse events
1 secondary outcome
Voluntariness for study participation
Time frame: 6 Months
Results and safety
The study was stopped early (reason given: lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Brivaracetam in people with Brain Tumor, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: lack of enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Brivaracetam (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.