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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GTX-104 | Experimental | 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 |
|
| Oral nimodipine | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GTX-104 | Drug | Nimodipine IV infusion |
| |
| Nimotop 30 MG Oral Capsule |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Hypotension events requiring medical treatment | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of episodes of clinically significant hypotension | Day 1 - Day 90 | |
| Duration of episodes of clinically significant hypotension | Calendar days | Day 1 - Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of intensive care unit (ICU) stays | Day 1 - Day 90 | |
| Duration of intensive care unit (ICU) stays | Day 1 - Day 90 | |
| Duration (calendar days) of mechanical ventilation |
Inclusion Criteria:
Male or female ≥18 years of age.
Diagnosis of aneurysmal subarachnoid hemorrhage (aSAH) based on CT scan and angiography (computed tomography angiography [CTA], magnetic resonance angiography [MRA], or digital subtraction angiography [DSA]).
Hunt and Hess score from I to V just prior to randomization.
Subject or the subject's legal representative has signed informed consent (either in person or by fax, scan, or email) before any study-specific procedures are performed.
Able to start IP within 96 hours from the onset of aSAH. Note 1: The onset of aSAH is defined as the time when the subject experienced the first symptom of aSAH (e.g., severe headache or loss of consciousness reported either by the subject or by a witness).
Note 2: If found unconscious or the time of first symptoms is unknown, the onset of aSAH will be defined as the last time the subject was seen at baseline neurological state.
If a woman of childbearing potential (WOCBP), must have a negative pregnancy test during the pre-randomization phase (screening). A woman is not of childbearing potential if she has undergone surgical sterilization (total hysterectomy, or bilateral tubal ligation, or bilateral oophorectomy at least 6 weeks before taking IP) or if she is abstinent (see below) or postmenopausal and has had no menstrual bleeding of any kind including menstrual period, irregular bleeding, spotting, etc., for at least 12 months, with an appropriate clinical profile, and there is no other cause of amenorrhea (e.g., hormonal therapy, prior chemotherapy).
WOCBP and males whose sexual partners are WOCBP must agree to use barrier contraception and a second form of contraception while receiving IP and for 30 days following their last dose of IP. Alternatively, total abstinence is also considered a highly effective contraception method when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
Sexually active males must use a condom during intercourse while taking IP and for 30 days after the last dose of IP and should not father a child during this period. A condom is required to be used also by vasectomized men as well as during intercourse with a male partner to prevent delivery of the IP via seminal fluid.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| R. Loch Macdonald, MD | Grace Therapeutics Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Brain and Spine Neurological Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39875683 | Derived | Choi AH, Chou SY, Ducruet AF, Kimberly WT, Loch Macdonald R, Rabinstein AA. Description of STRIVE-ON Study Protocol: Safety and Tolerability of GTX-104 (Nimodipine Injection for IV Infusion) Compared with Oral Nimodipine in Patients Hospitalized for Aneurysmal Subarachnoid Hemorrhage (aSAH): A Prospective, Randomized, Phase III Trial (STRIVE-ON). Neurocrit Care. 2025 Jun;42(3):1107-1117. doi: 10.1007/s12028-024-02207-8. Epub 2025 Jan 28. |
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| Drug |
Oral nimodipine capsules |
|
| 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 |
| Incidence of delayed cerebral ischemia (DCI) | Delayed cerebral ischemia will be evaluated and defined by the following:
| Day 1 - Day 21 |
| Use of rescue therapy for DCI | Rescue therapy is defined as induced hypertension, selective intraarterial infusion of vasodilator drugs or balloon angioplasty. | Day 1 - Day 21 |
| Suicidal ideation using the Columbia-Suicide Severity Rating Scale (C-SSRS) score of ≥ 4 | Day 1 - Day 90 |
| Day 1 - Day 90 |
| Therapeutic Intensity Scale (TIS) | Assessed on a daily basis until Day 14 post-aSAH for the occurrence or use of mechanical ventilation, ICP monitoring, a central venous or arterial line, an external ventricular drain, deep sedation, pharmacological paralysis, and whether or not the patient is comatose for a period of at least 8 hours on that day. | Day 1 - Day 14 |
| Number of hospital stays | Day 1 - Day 90 |
| Duration of hospital stays | Calendar days | Day 1 - Day 90 |
| Hospital discharge disposition | Discharge to: (e.g., home, rehabilitation, long-term care) | Day 1 - Day 90 |
| Quality of Life as measured by EQ-5D-3L | Day 30 and Day 90 |
| Modified Rankin Scale (mRS) | 0 - No symptoms
| Day 30 and Day 90 |
| Phoenix |
| Arizona |
| 85013 |
| United States |
| Community Regional Medical Center | Fresno | California | 93701 | United States |
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | United States |
| Emory University School of Medicine Emergency Neurosciences | Atlanta | Georgia | 30303 | United States |
| Northwestern Feinberg Pavillion Neuro and Spine ICU | Chicago | Illinois | 60611 | United States |
| Indiana University Health Methodist Hospital | Indianapolis | Indiana | 46202 | United States |
| University of Kentucky Hospital | Lexington | Kentucky | 40536 | United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| The Mount Sinai Hospital | New York | New York | 10029 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45219 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Methodist University Hospital | Memphis | Tennessee | 38104 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 1, 2026 | Apr 21, 2026 | 20 | ||
| Apr 28, 2026 | May 13, 2026 | 21 |
| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009553 | Nimodipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009539 | Nicotinic Acids |
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