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NCT01024972 · ClinicalTrials.gov registry record · Phase 1
Safety Study of Dantrolene in Subarachnoid Hemorrhage
A Phase 1 study, sponsored by University of Massachusetts, Worcester.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT01024972 is a Phase 1 study that has completed, run by University of Massachusetts, Worcester. The registered enrollment target is 31 participants.
The verdict
NCT01024972, a Phase 1 study, has completed, sponsored by University of Massachusetts, Worcester.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
Subarachnoid hemorrhage (SAH) is a devastating acute brain injury due to bleeding onto the brain surface from a ruptured aneurysm. Cerebral vasospasm (cVSP; critical narrowing of brain arteries) is a known complication after SAH and significantly increases disability and death after SAH. Vasospasm is difficult to treat and can lead to stroke. Animal studies have shown that the muscles in the artery wall play a role in cVSP. Dantrolene has been FDA approved and extensively used in clinical practice as a muscle relaxant for more than 30 years. It has been shown to provide some benefit in animal studies of cVSP, as well as in a small number of humans. However, the first human studies have only been observational and over a short period of time. This study will evaluate the safety and tolerability of intravenous dantrolene given every 6 hours over seven days to patients with or at risk for cVSP after SAH. The goal is to determine if future efficacy studies should be done to determine if treatment with Dantrolene may improve the outcome of patients with cVSP after SAH.
Interventions
- DRUG Placebo
- DRUG Dantrolene
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2009-10 |
| Est. Completion | 2013-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01024972
The ClinicalTrials.gov registry entry for NCT01024972 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Massachusetts, Worcester, which has 240 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01024972 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01024972 about?
NCT01024972 is a clinical study titled "Safety Study of Dantrolene in Subarachnoid Hemorrhage". Subarachnoid hemorrhage (SAH) is a devastating acute brain injury due to bleeding onto the brain surface from a ruptured aneurysm. Cerebral vasospasm (cVSP; critical narrowing of brain arteries) is a known complication after SAH and significantly increases disability and death after SAH. Vasospasm i...
What is the current status of trial NCT01024972?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2009-10. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01024972?
The interventions under investigation include: Placebo (DRUG), Dantrolene (DRUG).
Who is sponsoring clinical trial NCT01024972?
This trial is sponsored by University of Massachusetts, Worcester, which has 240 total clinical trials registered on ClinicalTrials.gov.
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