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Completed

NCT Number: NCT02486211

Amantadine to Speed Awakening After Cardiac Arrest

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.

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Key information

Conditions

Coma Anoxia Body Temperature Changes Cardiovascular Diseases Consciousness Disorders Heart Arrest Heart Diseases Hypothermia Hypoxia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms Signs and Symptoms, Respiratory Unconsciousness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Main Medical Center, Portland, Maine, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amantadine

Drug

100mg twice per day for 7 days at 0600 and 1200

Other names: Symmetrel

Placebo

Drug

Placebo comparator

Primary outcomes

  1. 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.

Secondary outcomes

  1. Time to Awakening

    Time frame: up to 28 days

    Defined as the time from enrollment to awakening

  2. 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

  3. Nausea or Vomiting

    Time frame: during study drug administration (7 days)

    nausea requiring antiemetic medications or clinical vomiting

  4. 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

Sponsors and collaborators

Lead sponsor

Jon Rittenberger, MD

Other

Collaborators

  • American Heart Association

Registry information

Acronym: AWAKE

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jul 1, 2015
Registry last updated
Dec 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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