NCT06552260

A Surgical Window of Opportunity Clinical Trial of Troriluzole in Recurrent IDH Wild-Type Glioblastoma

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Ugonma Chukwueke · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is studying troriluzole as a possible treatment for recurrent glioblastoma. The name of the study drug involved in this research study is: -Troriluzole (a tripeptide prodrug of riluzole)

Detailed description

This is an open-label, randomized window-of-opportunity study of Troriluzole in participants with surgically accessible, recurrent isocitrate dehydrogenase wild-type (IDH WT) glioblastoma (GBM). Surgical window-of-opportunity clinical trials test how active the investigational drug is on tumors. "Investigational" means that the drug is being studied. Participants will be randomized using a 2:1 ratio into one of two study treatment groups: Group A versus Group B. Randomization means a participant is placed into a study group by chance. Group A will receive Troriluzole prior to and after standard-of-care tumor resection surgery, while Group B will not receive Troriluzole prior to standard-of-care tumor resection surgery but will receive Troluzole after surgery. The research study procedures include screening for eligibility, study treatment visits, blood tests, tumor biopsies, Magnetic Resonance Imaging (MRI) scans, and electrocardiograms (ECGs). It is expected that about 27 participants will take part in this research study Biohaven Pharmaceuticals is funding this research study by providing study drug.

Conditions

• Glioblastoma
• Recurrent Glioblastoma
• Brain Tumor

Interventions

Type	Name	Description
DRUG	Troriluzole	Tripeptide prodrug of Riluzole, 100 mg capsule, taken orally per protocol.

Timeline

• Start date: 2025-02-19
• Primary completion: 2026-08-01
• Completion: 2027-08-01
• First posted: 2024-08-13
• Last updated: 2025-09-11

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study