AzTrials
AzTrials

Aneurysmal Subarachnoid Hemorrhage (aSAH)Phase 3STRIVE-ONNCT05995405

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

A Phase 3 study testing GTX-104 and Nimotop 30 MG Oral Capsule in people with Aneurysmal Subarachnoid Hemorrhage (aSAH), run by Grace Therapeutics Inc. at 22 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
GTX-104 and Nimotop 30 MG Oral Capsule
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
22 sitesUnited States
Study dates
20 Oct 2023to Dec 2024
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • Is at imminent risk of death and/or has Do Not Resuscitate (DNR) orders.
  • Required cardiopulmonary resuscitation within 4 days prior to randomization.
  • Has second- or third-degree atrio-ventricular block or bradycardia (heart rate ≤50 bpm) prior to randomization.
  • Has history of cirrhosis (Child-Pugh class B and C) prior to randomization.
  • Has alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) more than 2.5 times the upper limit of normal (ULN).
  • Has history of malabsorption syndrome, recent ileus (in the last 3 months), or other gastrointestinal (GI) conditions that would interfere with absorption of nimodipine, in the opinion of the Investigator.
Show all 13Show fewer
  • Has a severe or unstable concomitant condition or disease other than what may be attributed to the SAH that, in the opinion of the Investigator, may increase the risk associated with study participation or nimodipine administration, or may interfere with the interpretation of study results.
  • Has a history of recurrent syncope or hypotension that may interfere with the safety assessments of nimodipine.
  • Has a known hypersensitivity to nimodipine or capsule constituents or to GTX-104.
  • Is pregnant/has a positive serum or urine pregnancy test.
  • Has received more than 12 doses (or 720 mg) of oral nimodipine (as a solution [e.g., Nymalize] or capsules) as part of the standard of care (SOC) for the ruptured aneurysm prior to randomization.
  • Is receiving strong inhibitors of CYP3A4 such as some macrolide antibiotics (e.g., clarithromycin, telithromycin), some anti-HIV protease inhibitors (e.g., delavirdine, indinavir, nelfinavir, ritonavir, saquinavir), some azole antimycotics (e.g., ketoconazole, itraconazole, voriconazole), and some antidepressants (e.g., nefazadone). See Appendix 5.
  • Is receiving or has received any other investigational agent(s)/device(s) in the last 30 days.

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

United States22 sites

  • Emory University School of Medicine Emergency Neurosciences

    Atlanta, Georgia, 30303

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • The University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Northwestern Feinberg Pavillion Neuro and Spine ICU

    Chicago, Illinois, 60611

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

  • Duke University

    Durham, North Carolina, 27710

  • Community Regional Medical Center

    Fresno, California, 93701

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • Indiana University Health Methodist Hospital

    Indianapolis, Indiana, 46202

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224

  • University of Kentucky Hospital

    Lexington, Kentucky, 40536

  • Methodist University Hospital

    Memphis, Tennessee, 38104

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • The Mount Sinai Hospital

    New York, New York, 10029

  • Brain and Spine Neurological Institute

    Phoenix, Arizona, 85013

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • Washington University

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: 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 Trial

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.

Being tested
GTX-104, Nimotop 30 MG Oral Capsule
Medical subject headings
Subarachnoid Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GTX-104Drug

    Nimodipine IV infusion

  • Nimotop 30 MG Oral CapsuleDrug

    Oral nimodipine capsules

Study groups in NCT05995405
Study groupRoleWhat they receive
GTX-104ExperimentalGTX-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
Receives: Drug: GTX-104
Oral nimodipineActive comparatorOral nimodipine is a soft gelatin capsule. The dose is 60 mg (two 30 mg capsules) every 4 hours for up to 21 consecutive days.
Receives: Drug: Nimotop 30 MG Oral Capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 90 days

Secondary outcomes (6)

  1. Total number of episodes of clinically significant hypotension

    Measured: Day 1 - Day 90

  2. Duration of episodes of clinically significant hypotension

    Calendar days

    Measured: Day 1 - Day 90

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

    Measured: Day 1 - Day 90

  4. Incidence of delayed cerebral ischemia (DCI)

    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.

    Measured: Day 1 - Day 21

  5. Use of rescue therapy for DCI

    Rescue therapy is defined as induced hypertension, selective intraarterial infusion of vasodilator drugs or balloon angioplasty.

    Measured: Day 1 - Day 21

  6. Suicidal ideation using the Columbia-Suicide Severity Rating Scale (C-SSRS) score of ≥ 4

    Measured: Day 1 - Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2023
  2. Study start20 Oct 2023
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05995405
Sponsor's protocol ID
GTX-104-003
Acronym
STRIVE-ON
Status last verified
Sep 2024
First submitted
31 Jul 2023
Last updated
1 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39875683

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GTX-104 and Nimotop 30 MG Oral Capsule in people with Aneurysmal Subarachnoid Hemorrhage (aSAH), run by Grace Therapeutics Inc. at 22 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05995405, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in