Trial · NCT05995405
Safety and Tolerability of GTX-104 Compared with Oral Nimodipine in Patients with ASAH
NCT05995405, Phase 3, Active not recruiting, Grace Therapeutics Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Tolerability of GTX-104 Compared with Oral Nimodipine in Patients with ASAH. Trials, record NCT05995405. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05995405
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Tolerability of GTX-104 Compared with Oral Nimodipine in Patients with ASAH
- NCT number
- NCT05995405
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 100 participants, estimated
- Lead sponsor
- Grace Therapeutics Inc.
- Conditions
- Aneurysmal Subarachnoid Hemorrhage (aSAH)
- Interventions
- GTX-104, Nimotop 30 MG Oral Capsule
- First posted
- 2023-08-16
- Last updated
- 2024-10-01
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. | 90 days | Hypotension events requiring medical treatment |
| Secondary | Total number of episodes of clinically significant hypotension | Day 1 - Day 90 | |
| Secondary | Duration of episodes of clinically significant hypotension | Day 1 - Day 90 | Calendar days |
| Secondary | Incidence and severity of Adverse Events (AEs) based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, Version 5.0). | Day 1 - Day 90 | |
| Secondary | Incidence of delayed cerebral ischemia (DCI) | Day 1 - Day 21 | Delayed cerebral ischemia will be evaluated and defined by the following: * For subjects in whom changes in the mGCS and Abbreviated National Institutes of Health Stroke Scale (aNIHSS) are assessable: a decrease of at least 2 points on the mGCS or an increase of at least 2 points on the aNIHSS, lasting for at least 2 hours, where other medical or surgical causes are excluded. The deterioration is measured relative to the best score attained after aneurysm repair. * For subjects in whom the neurologic scales are not assessable: radiological evidence and clinical judgement. |
| Secondary | Use of rescue therapy for DCI | Day 1 - Day 21 | Rescue therapy is defined as induced hypertension, selective intraarterial infusion of vasodilator drugs or balloon angioplasty. |
| Secondary | Suicidal ideation using the Columbia-Suicide Severity Rating Scale (C-SSRS) score of ≥ 4 | Day 1 - Day 90 | |
| Other | Number of intensive care unit (ICU) stays | Day 1 - Day 90 | |
| Other | Duration of intensive care unit (ICU) stays | Day 1 - Day 90 | |
| Other | Duration (calendar days) of mechanical ventilation | Day 1 - Day 90 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39875683 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05995405
GET https://conductscience.org/api/trials/v1/NCT05995405/registered