Trial Outcomes & Findings for Safety Study of Nicardipine to Treat Cerebral Vasospasm (NCT NCT01810302)
NCT ID: NCT01810302
Last Updated: 2014-08-29
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
2 participants
Primary outcome timeframe
Day 1 of study drug until post-hemorrhage day 10.
Results posted on
2014-08-29
Participant Flow
Participant milestones
| Measure |
Nicardipine Hydrochloride
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
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 Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Nicardipine Hydrochloride
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
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 Study
Death
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Safety Study of Nicardipine to Treat Cerebral Vasospasm
Baseline characteristics by cohort
| Measure |
Nicardipine Hydrochloride
n=1 Participants
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
n=1 Participants
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
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 of study drug until post-hemorrhage day 10.Population: Number of participants were not sufficient to perform data analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 of study drug until post-hemorrhage day 10.Population: Number of participants were not sufficient to perform data analysis.
Outcome measures
Outcome data not reported
Adverse Events
Nicardipine Hydrochloride
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Preservative-free Normal Saline
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nicardipine Hydrochloride
n=1 participants at risk
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
n=1 participants at risk
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.
|
|---|---|---|
|
Nervous system disorders
Intracranial Hemorrhage
|
100.0%
1/1 • Adverse event monitoring began at the initiation of study procedures and continued until post-hemorrhage day 17.
|
0.00%
0/1 • Adverse event monitoring began at the initiation of study procedures and continued until post-hemorrhage day 17.
|
|
Gastrointestinal disorders
Gastointestinal Bleed
|
100.0%
1/1 • Adverse event monitoring began at the initiation of study procedures and continued until post-hemorrhage day 17.
|
0.00%
0/1 • Adverse event monitoring began at the initiation of study procedures and continued until post-hemorrhage day 17.
|
|
Gastrointestinal disorders
Gastic Ulcer Perforation
|
100.0%
1/1 • Adverse event monitoring began at the initiation of study procedures and continued until post-hemorrhage day 17.
|
0.00%
0/1 • Adverse event monitoring began at the initiation of study procedures and continued until post-hemorrhage day 17.
|
Other adverse events
| Measure |
Nicardipine Hydrochloride
n=1 participants at risk
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
n=1 participants at risk
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.
|
|---|---|---|
|
Nervous system disorders
Altered Mental Status
|
100.0%
1/1 • Adverse event monitoring began at the initiation of study procedures and continued until post-hemorrhage day 17.
|
100.0%
1/1 • Adverse event monitoring began at the initiation of study procedures and continued until post-hemorrhage day 17.
|
|
General disorders
Fever
|
100.0%
1/1 • Adverse event monitoring began at the initiation of study procedures and continued until post-hemorrhage day 17.
|
100.0%
1/1 • Adverse event monitoring began at the initiation of study procedures and continued until post-hemorrhage day 17.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
100.0%
1/1 • Adverse event monitoring began at the initiation of study procedures and continued until post-hemorrhage day 17.
|
0.00%
0/1 • Adverse event monitoring began at the initiation of study procedures and continued until post-hemorrhage day 17.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/1 • Adverse event monitoring began at the initiation of study procedures and continued until post-hemorrhage day 17.
|
100.0%
1/1 • Adverse event monitoring began at the initiation of study procedures and continued until post-hemorrhage day 17.
|
|
Vascular disorders
Hypotension
|
100.0%
1/1 • Adverse event monitoring began at the initiation of study procedures and continued until post-hemorrhage day 17.
|
0.00%
0/1 • Adverse event monitoring began at the initiation of study procedures and continued until post-hemorrhage day 17.
|
|
Nervous system disorders
Cerebrospinal Fluid Leakage
|
100.0%
1/1 • Adverse event monitoring began at the initiation of study procedures and continued until post-hemorrhage day 17.
|
0.00%
0/1 • Adverse event monitoring began at the initiation of study procedures and continued until post-hemorrhage day 17.
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
1/1 • Adverse event monitoring began at the initiation of study procedures and continued until post-hemorrhage day 17.
|
100.0%
1/1 • Adverse event monitoring began at the initiation of study procedures and continued until post-hemorrhage day 17.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/1 • Adverse event monitoring began at the initiation of study procedures and continued until post-hemorrhage day 17.
|
100.0%
1/1 • Adverse event monitoring began at the initiation of study procedures and continued until post-hemorrhage day 17.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/1 • Adverse event monitoring began at the initiation of study procedures and continued until post-hemorrhage day 17.
|
100.0%
1/1 • Adverse event monitoring began at the initiation of study procedures and continued until post-hemorrhage day 17.
|
|
Infections and infestations
Appendicitis
|
100.0%
1/1 • Adverse event monitoring began at the initiation of study procedures and continued until post-hemorrhage day 17.
|
0.00%
0/1 • Adverse event monitoring began at the initiation of study procedures and continued until post-hemorrhage day 17.
|
|
Vascular disorders
Thromboembolic Event
|
100.0%
1/1 • Adverse event monitoring began at the initiation of study procedures and continued until post-hemorrhage day 17.
|
0.00%
0/1 • Adverse event monitoring began at the initiation of study procedures and continued until post-hemorrhage day 17.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
100.0%
1/1 • Adverse event monitoring began at the initiation of study procedures and continued until post-hemorrhage day 17.
|
0.00%
0/1 • Adverse event monitoring began at the initiation of study procedures and continued until post-hemorrhage day 17.
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
1/1 • Adverse event monitoring began at the initiation of study procedures and continued until post-hemorrhage day 17.
|
0.00%
0/1 • Adverse event monitoring began at the initiation of study procedures and continued until post-hemorrhage day 17.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place