Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-30 @ 11:19 AM
Study NCT ID:
NCT06552260
Status:
RECRUITING
Last Update Posted:
2025-09-11
First Post:
2024-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Surgical Window of Opportunity Clinical Trial of Troriluzole in Recurrent IDH Wild-Type Glioblastoma
Sponsor:
Ugonma Chukwueke
Organization:
Study Overview
Official Title:
A Surgical Window of Opportunity Clinical Trial of Troriluzole in Recurrent IDH Wild-Type Glioblastoma
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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)
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: