Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06552260
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-09
Brief Title:
A Surgical Window of Opportunity Clinical Trial of Troriluzole in Recurrent IDH Wild-Type Glioblastoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Surgical Window of Opportunity Clinical Trial of Troriluzole in Recurrent IDH Wild-Type Glioblastoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 21 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 21 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None