- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02486211
Amantadine to Speed Awakening After Cardiac Arrest (AWAKE)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Maine
-
Portland, Maine, United States, 04101
- Main Medical Center
-
-
Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deacconness
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15219
- UPMC Mercy Hospital
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Pittsburgh, Pennsylvania, United States, 15216
- UPMC Presbyterian Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Non traumatic cardiac arrest
- Age 18 and older
- Defibrillation and/or chest compressions by healthcare providers
- Return of spontaneous circulation
Exclusion Criteria:
- Written do not attempt resuscitation (DNAR) reported to providers before randomization
- Known prisoner or pregnancy
- Lack of motor response to pain and absent N20 response on somatosensory evoked potentials prior to randomization
- Initial CT demonstrating brain edema (defined as grey white ratio <1.2)
- Presence of malignant pattern on EEG at time of randomization
- Next of kin unwilling to provide supportive care for at least one week after enrollment
- Presently using other dopaminergic agent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Placebo medication administered at 0600 and 1200 via mouth, gastric tube or duo-tube.
|
Placebo comparator
|
Experimental: Amantadine
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
up to 28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Awakening
Time Frame: up to 28 days
|
Defined as the time from enrollment to awakening
|
up to 28 days
|
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
|
during study drug administration (7 days)
|
Nausea or Vomiting
Time Frame: during study drug administration (7 days)
|
nausea requiring antiemetic medications or clinical vomiting
|
during study drug administration (7 days)
|
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
|
28 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jon C Rittenberger, MD, University of Pittsburgh
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Heart Arrest
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Peripheral Nervous System Agents
- Antiviral Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Dopamine Agents
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Amantadine
Other Study ID Numbers
- 15GRNT25680021
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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