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Safety Study of Nicardipine to Treat Cerebral Vasospasm

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01810302
Recruitment Status : Terminated (Unable to secure drug.)
First Posted : March 13, 2013
Results First Posted : August 29, 2014
Last Update Posted : August 29, 2014
Sponsor:
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE March 11, 2013
First Posted Date  ICMJE March 13, 2013
Results First Submitted Date  ICMJE August 18, 2014
Results First Posted Date  ICMJE August 29, 2014
Last Update Posted Date August 29, 2014
Study Start Date  ICMJE August 2013
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2014)
Number of Participants With Bacterial Meningitis. [ Time Frame: Day 1 of study drug until post-hemorrhage day 10. ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 11, 2013)
Number of participants with bacterial meningitis. [ Time Frame: Date of first dose of study drug until post-hemorrhage day 10. ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2014)
Number of Participants With Cerebral Vasospasm. [ Time Frame: Day 1 of study drug until post-hemorrhage day 10. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2013)
Number of participants with cerebral vasospasm. [ Time Frame: Date of first dose of study drug until post-hemorrhage day 10. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of Nicardipine to Treat Cerebral Vasospasm
Official Title  ICMJE Intraventricular Nicardipine for the Treatment of Cerebral Vasospasm: Prospective Pilot Study
Brief Summary The purpose of this study is to determine if intrathecal nicardipine is safe for the treatment of cerebral vasospasm.
Detailed Description

Subarachnoid hemorrhage accounts for approximately 5% of all strokes and affects 30,000 Americans per year. Poor outcome from aneurysmal subarachnoid hemorrhage (SAH) occurs in 50 to 75% of patients, and this is attributed to secondary ischemia in approximately 30% of patients. This delayed cerebral ischemia has been attributed to the anatomic narrowing of arteries in the cerebral vasculature which occurs following SAH.

Because of this relationship between cerebral vasospasm, cerebral ischemia, and poor outcome, there has been significant effort to establish treatments that decrease the incidence of vasospasm after SAH. Currently, medications and hemodynamic maneuvers are used as standard of care for the treatment of vasospasm and to improve outcome after SAH.

The calcium channel blocker, nimodipine, is one of the few treatments for vasospasm that has been shown to be of proven benefit. Nicardipine is another calcium channel blocker that has been evaluated in several studies via an intravenous administration route. These studies did show significant improvements in symptomatic and angiographic vasospasm, although a benefit in outcome was not seen. However, the intravenous administration of nicardipine was associated with significant systemic side effects that may have affected outcome including hypotension, pulmonary edema, and azotemia.

The administration of nicardipine via an intrathecal route avoids the systemic complications associated with intravenous dosing since the direct cerebrospinal fluid dosing is much lower. The result is that the systemic concentration will remain low avoiding systemic side effects, and central nervous system concentration will remain high. We propose that this difference may improve outcomes while minimizing complication related effects on patient outcomes.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Cerebral Vasospasm
Intervention  ICMJE
  • Drug: Nicardipine hydrochloride
    Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10.
    Other Names:
    • Nicardipine
    • Cardene
  • Drug: Preservative-free normal saline
    Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10.
    Other Names:
    • Normal saline
    • Placebo
    • NS
Study Arms  ICMJE
  • Experimental: Nicardipine hydrochloride
    Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10.
    Intervention: Drug: Nicardipine hydrochloride
  • Placebo Comparator: Preservative-free normal saline
    Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10.
    Intervention: Drug: Preservative-free normal saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 4, 2014)
2
Original Estimated Enrollment  ICMJE
 (submitted: March 11, 2013)
65
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female 18 years of age and older
  • Subarachnoid hemorrhage documented on head CT
  • Fisher Grade 3 or 4
  • Hunt Hess Grade 1-5
  • Cerebral aneurysm as definitive source of subarachnoid hemorrhage
  • Cerebral aneurysm must be treated via open or endovascular techniques
  • Presence of external ventricular drain
  • Written informed consent obtained from subject or subject's legally authorized representative

Exclusion Criteria:

  • Absence or inability to have an external ventricular drain (coagulopathy)
  • Non-aneurysmal subarachnoid hemorrhage (perimesencephalic)
  • Untreated cerebral aneurysm
  • Inability to be randomized prior to post-hemorrhage day 4
  • Elevated intra-cranial pressures that would preclude external ventricular drain clamping for 30-60 minutes
  • Inability to administer study medication (severe intra-ventricular hemorrhage, occluded external ventricular drain)
  • Inability to obtain angiography (coagulopathy, renal failure)
  • Pregnant
  • Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01810302
Other Study ID Numbers  ICMJE 034-2013
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University of Florida
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Florida
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Spiros L. Blackburn, MD University of Florida
PRS Account University of Florida
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP