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Safety and Tolerability of GTX-104 Compared with Oral Nimodipine in Patients with ASAH

NCT05995405 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-10-01

No results posted yet for this study

Summary

The purpose of this study is to deliver nimodipine via IV directly into the bloodstream and to determine if this is as safe and tolerable as oral nimodipine capsules.

Conditions

  • Aneurysmal Subarachnoid Hemorrhage (aSAH)

Interventions

DRUG

GTX-104

Nimodipine IV infusion

DRUG

Nimotop 30 MG Oral Capsule

Oral nimodipine capsules

Sponsors & Collaborators

  • Grace Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • R. Loch Macdonald, MD · Grace Therapeutics Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-20
Primary Completion
2024-12-31
Completion
2024-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05995405 on ClinicalTrials.gov