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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Cerebral Vasospasm
Interventions Drug: Nicardipine hydrochloride
Drug: Preservative-free normal saline
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Nicardipine Hydrochloride Preservative-free Normal Saline
Hide Arm/Group Description

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

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

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

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

Period Title: Overall Study
Started 1 1
Completed 0 0
Not Completed 1 1
Reason Not Completed
Death             1             0
Physician Decision             0             1
Arm/Group Title Nicardipine Hydrochloride Preservative-free Normal Saline Total
Hide Arm/Group Description

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

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

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

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

Total of all reporting groups
Overall Number of Baseline Participants 1 1 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
1
 100.0%
1
  50.0%
>=65 years
1
 100.0%
0
   0.0%
1
  50.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
Female
1
 100.0%
1
 100.0%
2
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 1 participants 2 participants
1 1 2
1.Primary Outcome
Title Number of Participants With Bacterial Meningitis.
Hide Description [Not Specified]
Time Frame Day 1 of study drug until post-hemorrhage day 10.
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants were not sufficient to perform data analysis.
Arm/Group Title Nicardipine Hydrochloride Preservative-free Normal Saline
Hide Arm/Group Description:

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

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

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

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Number of Participants With Cerebral Vasospasm.
Hide Description [Not Specified]
Time Frame Day 1 of study drug until post-hemorrhage day 10.
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants were not sufficient to perform data analysis.
Arm/Group Title Nicardipine Hydrochloride Preservative-free Normal Saline
Hide Arm/Group Description:

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

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

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

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse event monitoring began at the initiation of study procedures and continued until post-hemorrhage day 17.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nicardipine Hydrochloride Preservative-free Normal Saline
Hide Arm/Group Description

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

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

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

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

All-Cause Mortality
Nicardipine Hydrochloride Preservative-free Normal Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Nicardipine Hydrochloride Preservative-free Normal Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   1/1 (100.00%)   0/1 (0.00%) 
Gastrointestinal disorders     
Gastointestinal Bleed   1/1 (100.00%)  0/1 (0.00%) 
Gastic Ulcer Perforation   1/1 (100.00%)  0/1 (0.00%) 
Nervous system disorders     
Intracranial Hemorrhage   1/1 (100.00%)  0/1 (0.00%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Nicardipine Hydrochloride Preservative-free Normal Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   1/1 (100.00%)   1/1 (100.00%) 
Blood and lymphatic system disorders     
Leukocytosis   0/1 (0.00%)  1/1 (100.00%) 
Anemia   1/1 (100.00%)  0/1 (0.00%) 
Gastrointestinal disorders     
Diarrhea   1/1 (100.00%)  1/1 (100.00%) 
General disorders     
Fever   1/1 (100.00%)  1/1 (100.00%) 
Infections and infestations     
Urinary Tract Infection   0/1 (0.00%)  1/1 (100.00%) 
Appendicitis   1/1 (100.00%)  0/1 (0.00%) 
Metabolism and nutrition disorders     
Hypernatremia   1/1 (100.00%)  0/1 (0.00%) 
Hyponatremia   0/1 (0.00%)  1/1 (100.00%) 
Nervous system disorders     
Altered Mental Status   1/1 (100.00%)  1/1 (100.00%) 
Cerebrospinal Fluid Leakage   1/1 (100.00%)  0/1 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory Failure   1/1 (100.00%)  0/1 (0.00%) 
Vascular disorders     
Hypotension   1/1 (100.00%)  0/1 (0.00%) 
Thromboembolic Event   1/1 (100.00%)  0/1 (0.00%) 
Indicates events were collected by systematic assessment
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Spiros Blackburn
Organization: University of Florida
Phone: (352) 273-9000
EMail: spiros.blackburn@neurosurgery.ufl.edu
Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01810302    
Other Study ID Numbers: 034-2013
First Submitted: March 11, 2013
First Posted: March 13, 2013
Results First Submitted: August 18, 2014
Results First Posted: August 29, 2014
Last Update Posted: August 29, 2014