Clinical trial · Interventional
Tolerability and Activity of Brivaracetam (BRV) in Patients With Diffuse Gliomas
NCT05029960CI-TRIAL-00113537terminatedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lack of enrollment
Summary
Brief summary (as posted)
The purpose of this study is to determine whether the study medication, brivaracetam, is tolerable and safe for patients with brain tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brivaracetam | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- Brivaracetam at a dose of 50 mg twice daily for 6 months
- interventionNames
- Drug: Brivaracetam
Primary outcomes (1)
- measure
- Safety of Brivaracetam
- timeFrame
- 6 Months
- description
- Evaluate adverse events
Secondary outcomes (1)
- measure
- Voluntariness for study participation
- timeFrame
- 6 Months
- description
- Number of people that declined to participate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.