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

Running, not enrolling · Phase 3

Conditions studied: Aneurysmal Subarachnoid Hemorrhage (aSAH)

In brief

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.

Key facts

Study ID

NCT05995405

Run by

Grace Therapeutics Inc.

People needed

100

Starts

2023-10-20

Expected to finish

2024-12-01

Last updated by the study team

2024-10-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 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.

Where it is running

• The University of Alabama at Birmingham — Birmingham, Alabama, United States
• Brain and Spine Neurological Institute — Phoenix, Arizona, United States
• Community Regional Medical Center — Fresno, California, United States
• Mayo Clinic Florida — Jacksonville, Florida, United States
• Emory University School of Medicine Emergency Neurosciences — Atlanta, Georgia, United States
• Northwestern Feinberg Pavillion Neuro and Spine ICU — Chicago, Illinois, United States
• Indiana University Health Methodist Hospital — Indianapolis, Indiana, United States
• University of Kentucky Hospital — Lexington, Kentucky, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Washington University — St Louis, Missouri, United States
• The Mount Sinai Hospital — New York, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Duke University — Durham, North Carolina, United States
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Methodist University Hospital — Memphis, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Texas Health Science Center at Houston — Houston, Texas, United States
• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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