Trial Outcomes & Findings for Safety Study of Dantrolene to Treat Cerebral Vasospasm After Subarachnoid Hemorrhage (NCT NCT00964548)

Results Overview

Systolic Blood Pressure (Change from baseline systolic blood pressure (pre-infusion) over time until 135 minutes post-infusion).

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

10 participants

Primary outcome timeframe

baseline until 135 minutes post-infusion

Results posted on

2012-05-25

Participant Flow

Recruitment dates: June 2007 - October 2008 Massachusetts General Hospital NeuroICU

Participants were excluded from study if transcranial doppler (TCDs) did not show elevated velocities suggesting vasospasm. See inclusion criteria regarding specifics. After enrollment, TCDs were repeated. Once the repeat TCD confirmed elevated velocities suggestive of vasospasm, a single dose of IV dantrolene was infused.

Participant milestones

Participant milestones
Measure	Dantrolene (Low Dose) Single dose of Dantrolene 1.25 mg/kg infused over 60 min.	Dantrolene (High Dose) Single dose of Dantrolene 2.5 mg/kg infused over 60 min.
Overall Study STARTED	5	5
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety Study of Dantrolene to Treat Cerebral Vasospasm After Subarachnoid Hemorrhage

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dantrolene (Low Dose) n=5 Participants Single dose of Dantrolene 1.25 mg/kg infused over 60 min.	Dantrolene (High Dose) n=5 Participants Single dose of Dantrolene 2.5 mg/kg infused over 60 min.	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	42 years STANDARD_DEVIATION 9 • n=5 Participants	44 years STANDARD_DEVIATION 10 • n=7 Participants	43 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	5 participants n=7 Participants	10 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline until 135 minutes post-infusion

Systolic Blood Pressure (Change from baseline systolic blood pressure (pre-infusion) over time until 135 minutes post-infusion).

Outcome measures

Outcome measures
Measure	Dantrolene (Low Dose) n=5 Participants Single dose of Dantrolene 1.25 mg/kg infused over 60 min.	Dantrolene (High Dose) n=5 Participants Single dose of Dantrolene 2.5 mg/kg infused over 60 min.
Hemodynamic Parameters (Change From Baseline Systolic Blood Pressure (Pre-infusion) Over Time Until 135 Minutes Post-infusion)	-8 mmHg Interval -26.0 to 10.0	-3.4 mmHg Interval -19.0 to 12.0

SECONDARY outcome

Timeframe: baseline until 135 minutes post-infusion

Peak Systolic Velocity of vessel in vasospasm (Change from baseline peak systolic velocity (pre-infusion) over time until 135 minutes post-infusion).

Outcome measures

Outcome measures
Measure	Dantrolene (Low Dose) n=5 Participants Single dose of Dantrolene 1.25 mg/kg infused over 60 min.	Dantrolene (High Dose) n=5 Participants Single dose of Dantrolene 2.5 mg/kg infused over 60 min.
Transcranial Doppler Peak Systolic Velocity (Change From Baseline Peak Systolic Velocity (Pre-infusion) Over Time Until 135 Minutes Post-infusion)	-30 cm/s Interval -47.0 to 12.0	-26 cm/s Interval -56.0 to 8.0

SECONDARY outcome

Timeframe: baseline until 135 minutes post-infusion

Mean flow velocities of vessel in vasospasm (Change from baseline mean flow velocity (pre-infusion) over time until 135 minutes post-infusion).

Outcome measures

Outcome measures
Measure	Dantrolene (Low Dose) n=5 Participants Single dose of Dantrolene 1.25 mg/kg infused over 60 min.	Dantrolene (High Dose) n=5 Participants Single dose of Dantrolene 2.5 mg/kg infused over 60 min.
Transcranial Doppler Mean Flow Velocity (Change From Baseline Mean Flow Velocity (Pre-infusion) Over Time Until 135 Minutes Post-infusion)	-18 cm/s Interval -32.0 to -3.0	-13 cm/s Interval -34.0 to 8.0

Adverse Events

Dantrolene (Low Dose)

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Dantrolene (High Dose)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dantrolene (Low Dose) n=5 participants at risk Single dose of Dantrolene 1.25 mg/kg infused over 60 min.	Dantrolene (High Dose) n=5 participants at risk Single dose of Dantrolene 2.5 mg/kg infused over 60 min.
Vascular disorders Hypotension	20.0% 1/5 • Number of events 1 • Up to 24 hours after Dantrolene infusion	0.00% 0/5 • Up to 24 hours after Dantrolene infusion

Other adverse events

Other adverse events
Measure	Dantrolene (Low Dose) n=5 participants at risk Single dose of Dantrolene 1.25 mg/kg infused over 60 min.	Dantrolene (High Dose) n=5 participants at risk Single dose of Dantrolene 2.5 mg/kg infused over 60 min.
Vascular disorders Venous Irritation	0.00% 0/5 • Up to 24 hours after Dantrolene infusion	0.00% 0/5 • Up to 24 hours after Dantrolene infusion

Additional Information

Susanne Muehlschlegel, MD, MPH, Principal Investigator

UMASS Medical School

Phone: 508-856-4667

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place