Safety Study of Nicardipine to Treat Cerebral Vasospasm

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT01810302
Phase
PHASE2
Status
Terminated

Conditions

  • Cerebral Vasospasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nicardipine hydrochloride — DRUG
    Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10.
  • Preservative-free normal saline — DRUG
    Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10.

Study Details

The purpose of this study is to determine if intrathecal nicardipine is safe for the treatment of cerebral vasospasm.

Key Dates

Start date
Aug 31, 2013
Status verified
Aug 2014
Primary completion
Jan 31, 2014
Completion
Jan 31, 2014

Study Design

Enrollment
2 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nicardipine hydrochloride
    Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10.
  • Placebo Comparator: Preservative-free normal saline
    Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10.

Primary Outcome Measure

Number of Participants With Bacterial Meningitis. [ Time Frame: Day 1 of study drug until post-hemorrhage day 10. ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32610-

Find similar trials in Gainesville, FL

By research site
University of Florida· Gainesville, FL

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