NCT05029960

Brief Summary

The purpose of this study is to determine whether the study medication, brivaracetam, is tolerable and safe for patients with brain tumors.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started May 2022

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 1, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

May 17, 2022

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

3.3 years

First QC Date

August 25, 2021

Last Update Submit

August 6, 2024

Conditions

Brain Tumor

Keywords

Brain TumorBrivaracetamEpilepsy

Outcome Measures

Primary Outcomes (1)

  • Safety of Brivaracetam

    Evaluate adverse events

    6 Months

Secondary Outcomes (1)

  • Voluntariness for study participation

    6 Months

Study Arms (1)

Experimental

EXPERIMENTAL

Brivaracetam at a dose of 50 mg twice daily for 6 months

Drug: Brivaracetam

Interventions

BrivaracetamDRUG

Dose of 50 mg twice daily for 6 months

Experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years with pathologic diagnosis of a supratentorial diffuse astrocytic or oligodendroglial tumor
  • Patients must be able to provide informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Brain NeoplasmsEpilepsy

Interventions

brivaracetam

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor - Department of Neurology , Epilepsy (SMD)

Study Record Dates

First Submitted

August 25, 2021

First Posted

September 1, 2021

Study Start

May 17, 2022

Primary Completion

August 31, 2025

Study Completion

August 31, 2025

Last Updated

August 9, 2024

Record last verified: 2024-08

Locations

US(1)