Amantadine to Speed Awakening After Cardiac Arrest (AWAKE)
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|ClinicalTrials.gov Identifier: NCT02486211|
Recruitment Status : Completed
First Posted : July 1, 2015
Results First Posted : December 4, 2019
Last Update Posted : December 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Coma Heart Arrest Anoxia||Drug: Amantadine Drug: Placebo||Phase 2|
Amantadine has been used to help patients awaken following traumatic brain injury, but it has not been studied in patients with anoxic brain injury.
Amantadine is a dopamine agonist and may help with stimulating the brain to awaken. The investigators will randomize subjects who remain comatose 72 hours following resuscitation from cardiac arrest to either amantadine or placebo. They will be treated with either amantadine or placebo for 7 days.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Amantadine to Speed Awakening After Cardiac Arrest|
|Study Start Date :||September 2015|
|Actual Primary Completion Date :||June 30, 2018|
|Actual Study Completion Date :||June 30, 2018|
Placebo Comparator: Placebo
Placebo medication administered at 0600 and 1200 via mouth, gastric tube or duo-tube.
100mg Amantadine administered at 0600 and 1200 via mouth, gastric tube or duo-tube.
100mg twice per day for 7 days at 0600 and 1200
Other Name: Symmetrel
- Rate of Awakening (Number of Patients Who Are Able to Follow Commands) [ Time Frame: up to 28 days ]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.
- Time to Awakening [ Time Frame: up to 28 days ]Defined as the time from enrollment to awakening
- Seizures (Number of Patients Who Experience Seizures as Detected by EEG Monitoring With or Without Clinical Correlate) [ Time Frame: during study drug administration (7 days) ]detected by EEG monitoring with or without clinical correlate
- Nausea or Vomiting [ Time Frame: during study drug administration (7 days) ]nausea requiring antiemetic medications or clinical vomiting
- Number of Participants With Severe or Intracranial Bleeding [ Time Frame: 28 days ]Bleeding that does not stop with direct pressure, requires transfusion, or occurs in the intracranial vault
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): NCT02486211
|United States, Maine|
|Main Medical Center|
|Portland, Maine, United States, 04101|
|United States, Massachusetts|
|Beth Israel Deacconness|
|Boston, Massachusetts, United States, 02215|
|United States, Pennsylvania|
|UPMC Presbyterian Hospital|
|Pittsburgh, Pennsylvania, United States, 15216|
|UPMC Mercy Hospital|
|Pittsburgh, Pennsylvania, United States, 15219|
|Principal Investigator:||Jon C Rittenberger, MD||University of Pittsburgh|