Safety Study of Dantrolene to Treat Cerebral Vasospasm After Subarachnoid Hemorrhage

Completed · Phase 1/Phase 2

Conditions studied: Cerebral Vasospasm After Subarachnoid Hemorrhage

In brief

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.

Key facts

Study ID

NCT00964548

Run by

University of Massachusetts, Worcester

People needed

10

Starts

2007-07-01

Expected to finish

2009-10-01

Last updated by the study team

2012-05-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants with aneurysmal SAH admitted to the Massachusetts General Hospital NeuroICU (Blake 12) and undergoing standard-of-care daily transcranial doppler (TCD).
• Participants with unilateral or bilateral anterior cerebral artery (ACA), middle cerebral artery (MCA), posterior cerebral artery (PCA), or basilar artery vasospasm as defined by the following TCD criteria
• a >50% mean velocity increase from the baseline mean TCD velocity (baseline is the first TCD measurement, usually within 24hrs of admission), or
• peak systolic TCD velocities of 200 cm/s or higher in the MCA or ACA (for MCA with a concurrent ipsilateral LR of 3.0 or higher), or peak systolic TCD velocities of 120 cm/s or higher in the PCA or basilar artery, or
• any daily 100 cm/s peak systolic TCD velocity increase from the previous day, or
• any longitudinal mean TCD velocity increase of 80 cm/s or more

You may not qualify if…

• Inability to obtain consent from patient or health care proxy
• Age < 18 years
• Pregnancy
• Traumatic SAH
• Known allergy to dantrolene
• Prior history of cirrhosis or hepatitis B/C, or any two of the following three liver enzymes elevated to greater than: ALT >165 Units/L, AST >120 Units/L, alkaline phosphatase >345 Units/L (three times upper limit of normal)
• Participants on verapamil

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• UMASS Memorial Medical Center/UMASS Medical School — Worcester, Massachusetts, United States

Full record on ClinicalTrials.gov

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