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Safety Study of Dantrolene to Treat Cerebral Vasospasm After Subarachnoid Hemorrhage

NCT00964548 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2012-05-25

Study results available
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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

  • Cerebral Vasospasm After Subarachnoid Hemorrhage

Interventions

DRUG

Dantrolene

1.25 mg/kg IV once over 60 min

DRUG

Dantrolene

2.5 mg/kg IV once over 60 min

Sponsors & Collaborators

  • Massachusetts General Hospital

    collaborator OTHER

  • University of Massachusetts, Worcester

    lead OTHER

Principal Investigators

  • Susanne Muehlschlegel, MD · UMASS Medical School

  • John R Sims, MD · Massachusetts General Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00964548 on ClinicalTrials.gov