Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Subarachnoid Hemorrhage
• Age: Between 18 Year(s) - 100 Year(s)
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Diagnosis of aneurysmal subarachnoid hemorrhage (aSAH).
  2. Able to start treatment with the investigational product (IP) within 96 hours from the onset of aSAH.
  3. If a woman of childbearing potential (WOCBP), must have a negative pregnancy test within 7 days of the first dose of IP.
  4. Sexually active males must use a condom during intercourse while taking the IP and for 3 months after the last dose of IP and should not father a child during this period.

  
  

You may not be eligible for this study if the following are true:

• 1. Is at imminent risk of death and/or with Do Not Resuscitate (DNR) orders.
  2. Required cardiopulmonary resuscitation within 4 days prior to randomization.
  3. Has history of cirrhosis (Child-Pugh class B and C) prior to randomization.
  4. Has a known hypersensitivity to nimodipine or capsule constituents or GTX-104.
  5. Is pregnant/has a positive serum pregnancy test.
  6. Has received more than 5 doses 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.
  7. Is receiving strong inhibitors of CYP3A4 such as some macrolide antibiotics (e.g., clarithromycin, telithromycin), some anti-HIV protease inhibitors (e.g., delaviridine, indinavir, nelfinavir, ritonavir, saquinavir), some azole antimycotics (e.g., ketoconazole, itraconazole, voriconazole) and some antidepressants (e.g., nefazadone).
  8. Is receiving or has received any other investigational agent(s)/device(s) in the last 30 days.