Safety Study of Nicardipine to Treat Cerebral Vasospasm

August 18, 2014 updated by: University of Florida

Intraventricular Nicardipine for the Treatment of Cerebral Vasospasm: Prospective Pilot Study

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

2

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nicardipine hydrochloride
Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10.
Drug: Nicardipine hydrochloride
Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10.
Other Names:
  • Nicardipine
  • Cardene
Placebo Comparator: Preservative-free normal saline
Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10.
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:
  • Placebo
  • NS
  • Normal saline

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Cerebral Vasospasm.
Time Frame: Day 1 of study drug until post-hemorrhage day 10.
Day 1 of study drug until post-hemorrhage day 10.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Spiros L. Blackburn, MD, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

March 11, 2013

First Submitted That Met QC Criteria

March 11, 2013

First Posted (Estimate)

March 13, 2013

Study Record Updates

Last Update Posted (Estimate)

August 29, 2014

Last Update Submitted That Met QC Criteria

August 18, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 034-2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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