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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: Completed Phase 1 study of Cerebral Vasospasm After Subarachnoid Hemorrhage, sponsored by University of Massachusetts, Worcester.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Systolic Blood Pressure (Change from baseline systolic blood pressure (pre-infusion) over time until 135 minutes post-infusion).
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 |
What the finished NCT00964548 record still lists
NCT00964548 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00964548's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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