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NCT05995405 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Aneurysmal Subarachnoid Hemorrhage (aSAH), sponsored by Grace Therapeutics.

Active
Registry status
Phase 3
Development phase
100
Enrollment target
20
Study locations

NCT05995405: Active Phase 3 study of Aneurysmal Subarachnoid Hemorrhage (aSAH), sponsored by Grace Therapeutics.

NCT05995405 is a Phase 3 study of Aneurysmal Subarachnoid Hemorrhage (aSAH) that is active but no longer recruiting, run by Grace Therapeutics. The registered enrollment target is 100 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05995405, a Phase 3 study of Aneurysmal Subarachnoid Hemorrhage (aSAH), is active but no longer recruiting, sponsored by Grace Therapeutics.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
100 participants
Enrollment target
20
Study locations

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.

Primary Outcome

Hypotension events requiring medical treatment

Interventions

  • DRUG GTX-104
  • DRUG Nimotop 30 MG Oral Capsule

Study Locations (20)

Ohio

  • University of Cincinnati Medical Center - Cincinnati
  • University Hospitals Cleveland Medical Center - Cleveland
  • The Ohio State University Wexner Medical Center - Columbus

North Carolina

  • University of North Carolina - Chapel Hill
  • Duke University - Durham

Tennessee

  • Methodist University Hospital - Memphis
  • Vanderbilt University Medical Center - Nashville

Alabama

  • The University of Alabama at Birmingham - Birmingham

Arizona

  • Brain and Spine Neurological Institute - Phoenix

California

  • Community Regional Medical Center - Fresno

Florida

  • Mayo Clinic Florida - Jacksonville

Georgia

  • Emory University School of Medicine Emergency Neurosciences - Atlanta

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2023-10-20
Est. Completion 2024-12
Phase Phase 3
Grace Therapeutics

3 total trials

What the registry record for NCT05995405 still lists

NCT05995405 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).

The record links to 1 condition, with Aneurysmal Subarachnoid Hemorrhage (aSAH) appearing as the primary indexed condition, and to 2 interventions - of which GTX-104 is the first listed.

NCT05995405 names 20 study sites across 16 states, led by Ohio, North Carolina, Tennessee.

Frequently Asked Questions

What is clinical trial NCT05995405 about?

NCT05995405 is a clinical study titled "Safety and Tolerability of GTX-104 Compared with Oral Nimodipine in Patients with ASAH". 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.

What is the current status of trial NCT05995405?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2023-10-20. Estimated completion is 2024-12.

What conditions does trial NCT05995405 study?

This clinical trial studies the following conditions: Aneurysmal Subarachnoid Hemorrhage (aSAH).

What interventions are being tested in trial NCT05995405?

The interventions under investigation include: GTX-104 (DRUG), Nimotop 30 MG Oral Capsule (DRUG).

Who is sponsoring clinical trial NCT05995405?

This trial is sponsored by Grace Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05995405 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Aneurysmal Subarachnoid Hemorrhage (aSAH)

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05995405's enrollment target sits among peer trials

100 1682nd of 2000 higher than 288 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05995405, the US trial registry maintained by the National Library of Medicine. NCT05995405 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.