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

Brief description of study

***THIS STUDY IS FOR CURRENT HOSPITALIZED PATIENTS ONLY***

The only drug approved by the United States Food and Drug Administration (US FDA) for treatment of aneurysmal subarachnoid hemorrhage (aSAH) is nimodipine. It is given to patients to lower the possibility of DCI and vasospasm and to improve the chances of recovery. In the U.S., nimodipine is given by mouth (orally) as 60 mg (two 30 mg capsules) taken every 4 hours for up to 21 consecutive days.

Although nimodipine has been approved because it increases the chances of recovery from aSAH, nimodipine sometimes causes side effects, such as low blood pressure, which can be harmful.

This study is testing an investigational (experimental) drug or study medication, GTX 104, which is a new form of nimodipine that is administered through an intravenous (IV) line. “Investigational” means the new formulation being tested has not been approved by the US FDA for sale as a prescription or over-the-counter medication. GTX 104 is being tested to determine if it can be approved for use in the US.

The goal of this study is to deliver the nimodipine directly into your bloodstream to see if this way of giving the drug is as tolerable as the currently available oral nimodipine capsules. The safety of the investigational drug will also be studied.


Clinical Study Identifier: s23-00939
Principal Investigator: Aaron S Lord.


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