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Antiepileptic drug

Brivaracetam for Brain Tumor

Q: What is the projected enrollment size for this investigation?

Affirmative. Clinicaltrials.gov contains evidence that this experiment, which was initially posted on May 17th 2022, is actively searching for participants. 30 patients have been requested from one medical site to participate in the trial.

Q: Has this trial previously been conducted, or is it a pioneering effort?

Since 2017, UCB Biopharma S.P.R.L has sponsored research into the efficacy of brivaracetam as a drug therapy and it was recently approved for Phase 3 trials in 2021 following an initial study with 227 patients. Nowadays, 6 active clinical studies concerning this medication are being conducted across 16 different countries spanning 18 cities worldwide.

Q: Are there any opportunities for individuals to enroll in this clinical trial?

Affirmative, clinicaltrials.gov reveals that this investigation into medical efficacy is presently in need of participants. It was first published on May 17th 2022 and most recently updated the same day - it plans to register 30 patients at a single site.

Q: Has Brivaracetam been previously investigated through clinical trials?

At the present moment, 6 medical trials are being conducted into Brivaracetam. Of those active studies, 4 of them have reached phase 3 and there are 199 sites across Poznan and <a href="https://www.withpower.com/clinical-trials/new-york">New york</a> running investigations on this treatment.

Phase < 1

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am over 18 and have been diagnosed with a specific brain tumor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety of Brivaracetam

Secondary outcome measures

Voluntariness for study participation

Side effects data

From 2022 Phase 3 trial • 449 Patients • NCT03083665

19%

Somnolence

14%

Dizziness

Nasopharyngitis

Headache

Upper respiratory tract infection

Large intestine polyp

Calculus ureteric

Pyrexia

Miscarriage of partner

100%

80%

60%

40%

20%

Study treatment Arm

BRV 200 mg/Day

Placebo

BRV 50 mg/Day to OLTP BRV

Placebo to OLTP BRV

BRV 50 mg/Day

BRV 200 mg/Day to OLTP BRV

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

~4510

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor

838 Previous Clinical Trials

518,537 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the projected enrollment size for this investigation?

"Affirmative. Clinicaltrials.gov contains evidence that this experiment, which was initially posted on May 17th 2022, is actively searching for participants. 30 patients have been requested from one medical site to participate in the trial."

Answered by AI

Has this trial previously been conducted, or is it a pioneering effort?

"Since 2017, UCB Biopharma S.P.R.L has sponsored research into the efficacy of brivaracetam as a drug therapy and it was recently approved for Phase 3 trials in 2021 following an initial study with 227 patients. Nowadays, 6 active clinical studies concerning this medication are being conducted across 16 different countries spanning 18 cities worldwide."

Answered by AI

Are there any opportunities for individuals to enroll in this clinical trial?

"Affirmative, clinicaltrials.gov reveals that this investigation into medical efficacy is presently in need of participants. It was first published on May 17th 2022 and most recently updated the same day - it plans to register 30 patients at a single site."

Answered by AI

Has Brivaracetam been previously investigated through clinical trials?

"At the present moment, 6 medical trials are being conducted into Brivaracetam. Of those active studies, 4 of them have reached phase 3 and there are 199 sites across Poznan and New york running investigations on this treatment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Tolerability and Activity of Brivaracetam (BRV) in Patients With Diffuse Gliomas

Thomas Wychowski 2022. "Tolerability and Activity of Brivaracetam (BRV) in Patients With Diffuse Gliomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05029960.

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