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Calcium Channel Blocker

IV vs Oral Nimodipine for Subarachnoid Hemorrhage (STRIVE-ON Trial)

Phase 3
Waitlist Available
Research Sponsored by Acasti Pharma Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 30 and day 90
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial tests if IV nimodipine is as safe and well-tolerated as the pill form.

Who is the study for?
Adults diagnosed with aneurysmal subarachnoid hemorrhage (aSAH) can join this trial. They must have a certain severity score, agree to contraception if applicable, and start treatment within 96 hours of aSAH onset. Excluded are those allergic to nimodipine or GTX-104, pregnant women, anyone who's taken too much oral nimodipine already or other recent investigational treatments.
What is being tested?
The study is testing the safety and tolerability of GTX-104 given intravenously compared to standard oral nimodipine capsules in patients with bleeding from a brain aneurysm. The goal is to see if IV delivery is as safe as taking the drug by mouth.
What are the potential side effects?
Possible side effects may include hypersensitivity reactions for those allergic to ingredients in GTX-104 or nimodipine, heart-related issues like low heart rate or atrioventricular block for at-risk individuals, and potential liver enzyme elevations.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 30 and day 90
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 30 and day 90 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence (% or proportion) of subjects with at least one episode of clinically significant hypotension with a reasonable possibility that GTX-104/oral nimodipine caused the event, according to the Endpoint Adjudication Committee.
Secondary study objectives
Duration of episodes of clinically significant hypotension
Incidence of delayed cerebral ischemia (DCI)
Use of rescue therapy for DCI
Other study objectives
Duration of hospital stays
Hospital discharge disposition
Modified Rankin Scale (mRS)
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: GTX-104Experimental Treatment1 Intervention
GTX-104 is a sterile concentrate of 10 mg nimodipine/5 mL (2 mg/mL), to be diluted in normal saline to obtain a dosing solution composed of dispersed micelles containing nimodipine for IV infusion. It will be administered as a continuous IV infusion of 0.15 mg/hour and a 30-minute IV bolus of 4 mg every 4 hours for up to 21 days
Group II: Oral nimodipineActive Control1 Intervention
Oral nimodipine is a soft gelatin capsule. The dose is 60 mg (two 30 mg capsules) every 4 hours for up to 21 consecutive days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GTX-104
2021
Completed Phase 1
~60

Find a Location

Who is running the clinical trial?

Acasti Pharma Inc.Lead Sponsor
7 Previous Clinical Trials
1,364 Total Patients Enrolled
R. Loch Macdonald, MDStudy DirectorAcasti Pharma Inc.
~0 spots leftby Dec 2024
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