Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05995405 | Safety and Tolerability of GTX-104 Compared with Oral Nimodipine in Patients with ASAH | PHASE3 | ACTIVE NOT_RECRUITING | 100 | — | — | Oct 20, 2023 | Dec 1, 2024 | Oct 1, 2024 | 22 | United States |
Hypotension events requiring medical treatment
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| GTX-104 | DRUG | Nimodipine IV infusion |
| Nimotop 30 MG Oral Capsule | DRUG | Oral nimodipine capsules |
Inclusion Criteria: 1. Male or female ≥18 years of age. 2. Diagnosis of aneurysmal subarachnoid hemorrhage (aSAH) based on CT scan and angiography (computed tomography angiography \[CTA\], magnetic resonance angiography \[MRA\], or digital subtraction angiography \[DSA\]). 3. Hunt and Hess score fr...