Trial Outcomes & Findings for Amantadine to Speed Awakening After Cardiac Arrest (NCT NCT02486211)
NCT ID: NCT02486211
Last Updated: 2019-12-04
Results Overview
Defined as the ability to follow commands (i.e. "wiggle your toes" "open your eyes" "squeeze my fingers". This corresponds to a Full Outline of Unresponsiveness motor score of 4. FOUR (full outline of unresponsiveness) measures the following: Eye Response, Motor Response, Brainstem Reflexes, and Respirations.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
up to 28 days
Results posted on
2019-12-04
Participant Flow
Participant milestones
| Measure |
Amantadine
100mg Amantadine administered at 0600 and 1200 via mouth, gastric tube or duo-tube.
Amantadine: 100mg twice per day for 7 days at 0600 and 1200
|
Placebo
Placebo medication administered at 0600 and 1200 via mouth, gastric tube or duo-tube.
Placebo: Placebo comparator
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
|
Overall Study
COMPLETED
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Amantadine to Speed Awakening After Cardiac Arrest
Baseline characteristics by cohort
| Measure |
Placebo
n=7 Participants
Placebo medication administered at 0600 and 1200 via mouth, gastric tube or duo-tube.
Placebo: Placebo comparator
|
Amantadine
n=7 Participants
100mg Amantadine administered at 0600 and 1200 via mouth, gastric tube or duo-tube.
Amantadine: 100mg BID for 7 days at 0600 and 1200
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 9 • n=5 Participants
|
54 years
STANDARD_DEVIATION 16 • n=7 Participants
|
55 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 28 daysDefined as the ability to follow commands (i.e. "wiggle your toes" "open your eyes" "squeeze my fingers". This corresponds to a Full Outline of Unresponsiveness motor score of 4. FOUR (full outline of unresponsiveness) measures the following: Eye Response, Motor Response, Brainstem Reflexes, and Respirations.
Outcome measures
| Measure |
Amantadine
n=7 Participants
100mg Amantadine administered at 0600 and 1200 via mouth, gastric tube or duo-tube.
Amantadine: 100mg twice per day for 7 days at 0600 and 1200
|
Placebo
n=7 Participants
Placebo medication administered at 0600 and 1200 via mouth, gastric tube or duo-tube.
Placebo: Placebo comparator
|
|---|---|---|
|
Rate of Awakening (Number of Patients Who Are Able to Follow Commands)
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: up to 28 daysDefined as the time from enrollment to awakening
Outcome measures
| Measure |
Amantadine
n=2 Participants
100mg Amantadine administered at 0600 and 1200 via mouth, gastric tube or duo-tube.
Amantadine: 100mg twice per day for 7 days at 0600 and 1200
|
Placebo
n=2 Participants
Placebo medication administered at 0600 and 1200 via mouth, gastric tube or duo-tube.
Placebo: Placebo comparator
|
|---|---|---|
|
Time to Awakening
|
4 days
Interval 4.0 to 4.0
|
8 days
Interval 2.0 to 14.0
|
SECONDARY outcome
Timeframe: during study drug administration (7 days)detected by EEG monitoring with or without clinical correlate
Outcome measures
| Measure |
Amantadine
n=7 Participants
100mg Amantadine administered at 0600 and 1200 via mouth, gastric tube or duo-tube.
Amantadine: 100mg twice per day for 7 days at 0600 and 1200
|
Placebo
n=7 Participants
Placebo medication administered at 0600 and 1200 via mouth, gastric tube or duo-tube.
Placebo: Placebo comparator
|
|---|---|---|
|
Seizures (Number of Patients Who Experience Seizures as Detected by EEG Monitoring With or Without Clinical Correlate)
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: during study drug administration (7 days)nausea requiring antiemetic medications or clinical vomiting
Outcome measures
| Measure |
Amantadine
n=7 Participants
100mg Amantadine administered at 0600 and 1200 via mouth, gastric tube or duo-tube.
Amantadine: 100mg twice per day for 7 days at 0600 and 1200
|
Placebo
n=7 Participants
Placebo medication administered at 0600 and 1200 via mouth, gastric tube or duo-tube.
Placebo: Placebo comparator
|
|---|---|---|
|
Nausea or Vomiting
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 28 daysBleeding that does not stop with direct pressure, requires transfusion, or occurs in the intracranial vault
Outcome measures
| Measure |
Amantadine
n=7 Participants
100mg Amantadine administered at 0600 and 1200 via mouth, gastric tube or duo-tube.
Amantadine: 100mg twice per day for 7 days at 0600 and 1200
|
Placebo
n=7 Participants
Placebo medication administered at 0600 and 1200 via mouth, gastric tube or duo-tube.
Placebo: Placebo comparator
|
|---|---|---|
|
Number of Participants With Severe or Intracranial Bleeding
|
0 Participants
|
0 Participants
|
Adverse Events
Amantadine
Serious events: 0 serious events
Other events: 1 other events
Deaths: 4 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 3 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Amantadine
n=7 participants at risk
100mg Amantadine administered at 0600 and 1200 via mouth, gastric tube or duo-tube.
Amantadine: 100mg BID for 7 days at 0600 and 1200
|
Placebo
n=7 participants at risk
Placebo medication administered at 0600 and 1200 via mouth, gastric tube or duo-tube.
Placebo: Placebo comparator
|
|---|---|---|
|
Gastrointestinal disorders
Tongue swelling
|
14.3%
1/7 • Number of events 1 • 7 days
|
0.00%
0/7 • 7 days
|
|
Nervous system disorders
seizure
|
0.00%
0/7 • 7 days
|
28.6%
2/7 • Number of events 2 • 7 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place