Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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

Condition or disease Intervention/treatment Phase
Cerebral Vasospasm Drug: Nicardipine hydrochloride Drug: Preservative-free normal saline Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Intraventricular Nicardipine for the Treatment of Cerebral Vasospasm: Prospective Pilot Study
Study Start Date : August 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


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:
  • Normal saline
  • Placebo
  • NS




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

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01810302


Locations
Layout table for location information
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
Layout table for investigator information
Principal Investigator: Spiros L. Blackburn, MD University of Florida

Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01810302     History of Changes
Other Study ID Numbers: 034-2013
First Posted: March 13, 2013    Key Record Dates
Results First Posted: August 29, 2014
Last Update Posted: August 29, 2014
Last Verified: August 2014
Keywords provided by University of Florida:
Vasospasm
Subarachnoid hemorrhage
Aneurysmal subarachnoid hemorrhage
Nicardipine
Intrathecal
SAH
aSAH
Additional relevant MeSH terms:
Layout table for MeSH terms
Vasospasm, Intracranial
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Nicardipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents