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NCT01024972 · ClinicalTrials.gov registry record · Phase 1

Safety Study of Dantrolene in Subarachnoid Hemorrhage

A Phase 1 study, sponsored by University of Massachusetts, Worcester.

Completed
Registry status
Phase 1
Development phase
31
Enrollment target

NCT01024972: Completed Phase 1 study, sponsored by University of Massachusetts, Worcester.

NCT01024972 is a Phase 1 study that has completed, run by University of Massachusetts, Worcester. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01024972, a Phase 1 study, has completed, sponsored by University of Massachusetts, Worcester.

COMPLETED
Registry status
Phase 1
Development phase
31 participants
Enrollment target

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. However, the first human studies have only been observational and over a short period of time. This study will evaluate the safety and tolerability of intravenous dantrolene given every 6 hours over seven days to patients with or at risk for cVSP after SAH. The goal is to determine if future efficacy studies should be done to determine if treatment with Dantrolene may improve the outcome of patients with cVSP after SAH.

Primary Outcome

Number of subjects who developed hyponatremia (sNa ≤132mmol/L)

Interventions

  • DRUG Placebo
  • DRUG Dantrolene

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2009-10
Est. Completion 2013-10
Phase Phase 1

What the finished NCT01024972 record still lists

NCT01024972 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01024972 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01024972 about?

NCT01024972 is a clinical study titled "Safety Study of Dantrolene in 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 NCT01024972?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2009-10. Estimated completion is 2013-10.

What interventions are being tested in trial NCT01024972?

The interventions under investigation include: Placebo (DRUG), Dantrolene (DRUG).

Who is sponsoring clinical trial NCT01024972?

This trial is sponsored by University of Massachusetts, Worcester, which has 240 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01024972's enrollment target sits among peer trials

31 1322nd of 2000 higher than 669 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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Source: ClinicalTrials.gov NCT01024972, the US trial registry maintained by the National Library of Medicine. NCT01024972 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.