Cerebral Vasospasm After Subarachnoid Hemorrhage Clinical Trial
Official title:
Dantrolene in the Treatment of Cerebral Vasospasm After Subarachnoid Hemorrhage - a Phase 1 Study
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.
Our main objectives are: 1) to evaluate the safety and tolerability of varying doses of
dantrolene, by determining the treatment related adverse events, in participants with cVSP
after SAH; and 2) to determine the maximal tolerated dose to be adopted in subsequent
studies and 3) to determine efficacy trends of dantrolene on brain vessels as assessed by
ultrasound of brain vessels (transcranial Doppler).
We hypothesize that dantrolene is well-tolerated and has minimal serious adverse effects in
patients with cVSP after SAH. The results can potentially bring a new treatment to patients
with SAH. cVPS after SAH is a frequent cause of disability and death. A successful study
demonstrating the safety of dantrolene in would be of considerable public health
significance.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT01400360 -
Invasive Diagnostic and Therapeutic Management of Cerebral Vasospasm After Aneurysmatic Subarachnoid Hemorrhage
|
N/A |