NCT01810302

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 13, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
8 months until next milestone

Results Posted

Study results publicly available

August 29, 2014

Completed
Last Updated

August 29, 2014

Status Verified

August 1, 2014

Enrollment Period

5 months

First QC Date

March 11, 2013

Results QC Date

August 18, 2014

Last Update Submit

August 18, 2014

Conditions

Cerebral Vasospasm

Keywords

VasospasmSubarachnoid hemorrhageAneurysmal subarachnoid hemorrhageNicardipineIntrathecalSAHaSAH

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Bacterial Meningitis.

    Day 1 of study drug until post-hemorrhage day 10.

Secondary Outcomes (1)

  • Number of Participants With Cerebral Vasospasm.

    Day 1 of study drug until post-hemorrhage day 10.

Study Arms (2)

Nicardipine hydrochloride

EXPERIMENTAL

Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10.

Drug: Nicardipine hydrochloride

Preservative-free normal saline

PLACEBO COMPARATOR

Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10.

Drug: Preservative-free normal saline

Interventions

Nicardipine hydrochlorideDRUG

Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10.

Also known as: Nicardipine, Cardene
Nicardipine hydrochloride
Preservative-free normal salineDRUG

Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10.

Also known as: Normal saline, Placebo, NS
Preservative-free normal saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Vasospasm, IntracranialSubarachnoid Hemorrhage

Interventions

NicardipineSaline Solution

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesIntracranial HemorrhagesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Limitations and Caveats

This single center study was terminated early due to inability to maintain an adequate drug supply; therefore, statistical analysis of the 2 participants was not done.

Results Point of Contact

Title
Dr. Spiros Blackburn
Organization
University of Florida
spiros.blackburn@neurosurgery.ufl.edu
(352) 273-9000

Study Officials

  • Spiros L. Blackburn, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2013

First Posted

March 13, 2013

Study Start

August 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

August 29, 2014

Results First Posted

August 29, 2014

Record last verified: 2014-08

Locations

US(1)