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Group A: Presurgical Troriluzole for Glioblastoma

Phase < 1
Waitlist Available
Led By Eudocia Lee, MD, MPH
Research Sponsored by Eudocia Quant Lee, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Age ≥18 years
* Histopathologically confirmed IDH-wildtype glioblastoma, WHO Grade 4, and variants including gliosarcoma as per WHO 2021 criteria (38).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from tumor tissue resected at surgery
Awards & highlights

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)

Who is the study for?
This trial is for individuals with recurrent glioblastoma, which is a type of brain tumor that has returned after treatment. Participants should not have any mutations in the IDH gene.
What is being tested?
The study is testing Troriluzole, a drug designed to treat recurrent glioblastoma. It's given before surgery to see if it can help control the growth of the tumor.
What are the potential side effects?
Possible side effects of Troriluzole may include dizziness, gastrointestinal discomfort, fatigue, and changes in liver enzymes. Specific side effect profiles will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from tumor tissue resected at surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and from tumor tissue resected at surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The effect of troriluzole on high-gamma band power (a measure of neuronal activity) via electrocorticography during surgical resection
Secondary study objectives
Concentrations of Extracellular Glutamate in Resected Tissue by MALDI-MSI
Grade 3-5 Treatment Related Adverse Event
Proliferation Rate (Ki-67) in Resected Tissue
+3 more

Side effects data

From 2020 Phase 3 trial • 881 Patients • NCT03829241
9%
Nausea
5%
Fatigue
5%
Upper respiratory tract infection
4%
Headache
3%
Nasopharyngitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Troriluzole - Randomization Phase
Placebo - Randomization Phase
Troriluzole - Randomization Phase/Troriluzole - Extension Phase
Placebo - Randomization Phase/Troriluzole - Extension Phase

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group B: Surgery + TroriluzoleExperimental Treatment1 Intervention
9 participants will be randomly assigned to this group and with complete: * Baseline visit with assessments and MRI * Day 0: pre-op MRI * Day 0: standard of care surgical resection of tumor * Day 0: post-op MRI * Cycle 1 through Cycle 3: --Days 1 through 28 of 28 day cycle: Predetermined dose of Troriluzole 2x daily. * Cycle 3 through End of Treatment: --Days 1 through 28 of 28 day cycle: Predetermined dose of Troriluzole 2x daily. * MRIs every 8 weeks while on treatment. * End of study visit with MRI * Follow up every 3 months for 1 year, and then every 6 months for the next 3 years.
Group II: Group A: Presurgical TroriluzoleExperimental Treatment1 Intervention
18 participants will be randomly assigned to this group and with complete: * Baseline visit with assessments and MRI. * Cycle 0: * Day -6 through Day 0: Predetermined dose of Troriluzole 2x daily. * Day 0: pre-op MRI * Day 0: standard of care surgical resection of tumor * Day 0: post-op MRI * Cycle 1 through Cycle 3: --Days 1 through 28 of 28 day cycle: Predetermined dose of Troriluzole 2x daily. * Cycle 3 through End of Treatment: --Days 1 through 28 of 28 day cycle: Predetermined dose of Troriluzole 2x daily. * MRIs every 8 weeks while on treatment. * End of study visit with MRI * Follow up every 3 months for 1 year, and then every 6 months for the next 3 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Troriluzole
2019
Completed Phase 3
~890

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,754 Previous Clinical Trials
8,131,647 Total Patients Enrolled
12 Trials studying Glioblastoma
620 Patients Enrolled for Glioblastoma
Biohaven Pharmaceuticals, Inc.Industry Sponsor
48 Previous Clinical Trials
37,288 Total Patients Enrolled
1 Trials studying Glioblastoma
1,030 Patients Enrolled for Glioblastoma
Eudocia Quant Lee, MDLead Sponsor
1 Previous Clinical Trials
81 Total Patients Enrolled
~18 spots leftby Aug 2026
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