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Calcium Channel Blocker

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

Phase 3

Recruiting

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

STRIVE-ON 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.Check my eligibility

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.See study design

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.

STRIVE-ON Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 30 and day 90

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Duration of episodes of clinically significant hypotension

Incidence and severity of Adverse Events (AEs) based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, Version 5.0).

Incidence of delayed cerebral ischemia (DCI)

+3 more

Other outcome measures

Duration (calendar days) of mechanical ventilation

Duration of hospital stays

Duration of intensive care unit (ICU) stays

+6 more

Side effects data

From 2009 Phase 4 trial • 22 Patients • NCT00814658

33%

Aggressiveness

22%

Vomiting

11%

Malaise

11%

Cachexia

11%

Nausea

11%

Headache

11%

Blood glucose floating

11%

Gastrointestinal anomaly

11%

Diarrhea

11%

Dyspepsia

11%

Loss weight

11%

Murmur

11%

Respiratory airways bacterial infection

11%

Upper respiratory airways viral infection

11%

Agitation

11%

Visual hallucination

11%

Depression

11%

Confusional state

11%

Asthenia

11%

Flu symptoms

11%

Fatigue

11%

Fall

100%

80%

60%

40%

20%

Study treatment Arm

Galantamine + Nimodipine

Galantamine + Placebo

STRIVE-ON 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

Do I qualify?Apply below to find out

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.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you provide an assessment of the risks associated with GTX-104 use?

"There is a body of evidence backing the safety of GTX-104, which has been given an overall score of 3 on our internal rating system. This includes both supportive data from efficacy studies and multiple rounds of safety assessments."

Answered by AI

Is recruitment open for this research endeavor?

"As per clinicaltrials.gov, this study is currently recruiting patients and was initially made available on October 20th of the current year with a subsequent update released three days later."

Answered by AI

What is the capacity of participants for this research initiative?

"Affirmative. The clinical data published on clinicaltrials.gov confirms this investigation has open recruitment, which commenced on October 20th 2021 and was last modified on October 23rd 2021. To reach the goal of 100 participants, only one site is required."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Tolerability of GTX-104 Compared With Oral Nimodipine in Patients With aSAH

2023. "Safety and Tolerability of GTX-104 Compared With Oral Nimodipine in Patients With aSAH". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05995405.

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