Amantadine to Speed Awakening After Cardiac Arrest (AWAKE)

November 18, 2019 updated by: Jon Rittenberger, MD
This study evaluates if amantadine will increase the rate of awakening in patients resuscitated from cardiac arrest but comatose (not following commands) after their resuscitation. Half of the participants will receive amantadine and the other will receive placebo.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

14

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maine
      • Portland, Maine, United States, 04101
        • Main Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deacconness
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15219
        • UPMC Mercy Hospital
      • Pittsburgh, Pennsylvania, United States, 15216
        • UPMC Presbyterian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Drug: Placebo
Placebo comparator
Experimental: Amantadine
100mg Amantadine administered at 0600 and 1200 via mouth, gastric tube or duo-tube.
Drug: Amantadine
100mg twice per day for 7 days at 0600 and 1200
Other Names:
  • Symmetrel

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

This is where you will find people and organizations involved with this study.

Sponsor

Jon Rittenberger, MD

Collaborators

American Heart Association

Investigators

  • Principal Investigator: Jon C Rittenberger, MD, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

June 30, 2018

Study Registration Dates

First Submitted

June 23, 2015

First Submitted That Met QC Criteria

June 30, 2015

First Posted (Estimate)

July 1, 2015

Study Record Updates

Last Update Posted (Actual)

December 4, 2019

Last Update Submitted That Met QC Criteria

November 18, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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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