A Phase 3 interventional study of GTX-104 and Nimotop 30 MG Oral Capsule in Aneurysmal Subarachnoid Hemorrhage (aSAH), sponsored by Grace Therapeutics Inc.. Active, not recruiting at 22 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-01.
Sponsored by Grace Therapeutics Inc. · Phase 3, Interventional, and Treatment
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Among 149 studies in Subarachnoid Hemorrhage with a site in United States — 31 open to participants now, 37 under way, 2 of them phase 3. Subarachnoid Hemorrhage · United States.
Among the 149 studies in Subarachnoid Hemorrhage with a site in United States, this one is the 22nd largest by planned enrollment of the 107 interventional ones that give a count, is one of 7 that started in 2023, is one of 9 in phase 3, reaches primary completion later than 2 of the 36 other live ones, and was the 126th registered.
510 studies on the registry are indexed under Subarachnoid Hemorrhage; 128 are open to participants now.
Browse Subarachnoid Hemorrhage studies →31 of the 149 studies in Subarachnoid Hemorrhage with a site in United States are open now. Recruiting first, the newest first:
Columbia University · Sites in United States, Brazil, Canada and 2 more countries
Ages 18+
Daniel Raper, MBBS · Sites in United States
Ages 18+
University of Louisville · Sites in United States
Ages 18+
University of Florida · Sites in United States
Ages 18–89
Marshall Holland · Sites in United States
Ages 18–65
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 89 Subarachnoid Hemorrhage studies recruiting now, 56 (63%) set no upper age limit and 4 (4%) stop at 75 or younger; 7 take children under 18; 7 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
149 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 27 · Phase 2 33 · Phase 3 11 · Phase 4 17
First in 1999; this study’s year is marked. 7 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 100 is above the median of 57 across 264 interventional studies indexed under Subarachnoid Hemorrhage.
Median enrollment 30 across the 107 interventional studies, 60 across the 42 observational. Of the 94 that completed or were terminated, 38 (40%) have results posted.
This tab as a report to print or save as PDF → With an account.
23 of 149 have an industry lead sponsor. The 10 most frequent:
Grace Therapeutics Inc. is the lead sponsor of 8 studies on the registry; none are open to participants now.
Grace Therapeutics Inc. has 2 studies filed under Subarachnoid Hemorrhage — fewer than ten, so there is no comparison to draw.
13 of the studies in Subarachnoid Hemorrhage with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06621329Phase 3University of California, DavisTransnasal Sphenopalatine Ganglion Block for Treatment of Acute Subarachnoid Hemorrhage Associated Headache | 2027-07 |
| NCT07116408Wright State UniversityIntranasal Sphenopalatine Ganglion Blockade for Headaches Following Aneurysmal Subarachnoid Hemorrhage | 2026-11 |
| NCT06103201University of Maryland, BaltimoreHyperpolarized 13C-pyruvate Metabolic MRI With Traumatic Brain Injury | 2026-11-26 |
| NCT05230134Stanford UniversityCervical Sympathetic Block in Patients With Cerebral Vasospasm | 2026-12 |
| NCT06119061Aaron CookTelavancin Blood and Cerebrospinal Fluid Concentrations in Patients With External Ventricular Drainage | 2026-12 |
Add all 13 to your calendar (.ics) → With an account.
Among the 149 studies in Subarachnoid Hemorrhage with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 (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 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 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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: GTX-104
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.
Drug: Nimotop 30 MG Oral Capsule
Nimodipine IV infusion
Oral nimodipine capsules
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
Time frame: 90 days
Total number of episodes of clinically significant hypotension
Time frame: Day 1 - Day 90
Duration of episodes of clinically significant hypotension
Calendar days
Time frame: Day 1 - Day 90
Incidence and severity of Adverse Events (AEs) based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, Version 5.0).
Time frame: Day 1 - Day 90
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.
Time frame: 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.
Time frame: Day 1 - Day 21
Suicidal ideation using the Columbia-Suicide Severity Rating Scale (C-SSRS) score of ≥ 4
Time frame: Day 1 - Day 90
Number of intensive care unit (ICU) stays
Time frame: Day 1 - Day 90
Duration of intensive care unit (ICU) stays
Time frame: Day 1 - Day 90
Duration (calendar days) of mechanical ventilation
Time frame: 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.
Time frame: Day 1 - Day 14
Number of hospital stays
Time frame: Day 1 - Day 90
Duration of hospital stays
Calendar days
Time frame: Day 1 - Day 90
Hospital discharge disposition
Discharge to: (e.g., home, rehabilitation, long-term care)
Time frame: Day 1 - Day 90
Quality of Life as measured by EQ-5D-3L
Time frame: Day 30 and Day 90
Modified Rankin Scale (mRS)
0 - No symptoms 1. - No significant disability despite symptoms; able to carry out all usual duties and activities 2. - Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. - Moderate disability; requiring some help, but able to walk without assistance 4. - Moderately severe disability; unable to walk and attend to bodily needs without assistance 5. - Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. - Dead
Time frame: Day 30 and Day 90
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2023 (actual). Primary completion is estimated for Dec 2024, 14 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Grace Therapeutics Inc.