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NCT00964548 · ClinicalTrials.gov registry record · Phase 1
Safety Study of Dantrolene to Treat Cerebral Vasospasm After Subarachnoid Hemorrhage
A Phase 1 study of Cerebral Vasospasm After Subarachnoid Hemorrhage, sponsored by University of Massachusetts, Worcester.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 2
- Study locations
NCT00964548 is a Phase 1 study of Cerebral Vasospasm After Subarachnoid Hemorrhage that has completed, run by University of Massachusetts, Worcester. The registered enrollment target is 10 participants. The trial reports 2 study locations across 1 state.
The verdict
NCT00964548, a Phase 1 study of Cerebral Vasospasm After Subarachnoid Hemorrhage, has completed, sponsored by University of Massachusetts, Worcester.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 2
- Study locations
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. Therefore, we plan to undertake this study to evaluate the safety and tolerability of treatment with dantrolene in patients with cVSP after SAH, and to determine the maximal tolerated dose to be used in future studies to determine if treatment with Dantrolene can improve the outcome of patients with cVSP after SAH.
Conditions Studied
Interventions
- DRUG Dantrolene
Study Locations (2)
Massachusetts
- Massachusetts General Hospital - Boston
- UMASS Memorial Medical Center/UMASS Medical School - Worcester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2007-07 |
| Est. Completion | 2009-10 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00964548
The ClinicalTrials.gov registry entry for NCT00964548 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 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 1 condition, with Cerebral Vasospasm After Subarachnoid Hemorrhage appearing as the primary indexed condition, and to 1 intervention - of which Dantrolene is the first listed.
NCT00964548 reports 2 study locations spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00964548 about?
NCT00964548 is a clinical study titled "Safety Study of Dantrolene to Treat Cerebral Vasospasm After 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 NCT00964548?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2007-07. Estimated completion is 2009-10.
What conditions does trial NCT00964548 study?
This clinical trial studies the following conditions: Cerebral Vasospasm After Subarachnoid Hemorrhage.
What interventions are being tested in trial NCT00964548?
The interventions under investigation include: Dantrolene (DRUG).
Who is sponsoring clinical trial NCT00964548?
This trial is sponsored by University of Massachusetts, Worcester, which has 240 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00964548 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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