Amantadine to Speed Awakening After Cardiac Arrest

Heart Arrest Clinical Trial

— AWAKE  

Official title:

Amantadine to Speed Awakening After Cardiac Arrest

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02486211
• Other study ID #: 15GRNT25680021
• Status: Completed
• Phase: Phase 2
• Start date: September 2015
• Est. completion date: June 30, 2018

Study information

• Verified date: November 2019
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anoxia
• Coma
• Heart Arrest

Intervention

Drug:
• Amantadine
100mg twice per day for 7 days at 0600 and 1200
• Placebo
Placebo comparator

Locations

Country	Name	City	State
United States	Beth Israel Deacconness	Boston	Massachusetts
United States	UPMC Mercy Hospital	Pittsburgh	Pennsylvania
United States	UPMC Presbyterian Hospital	Pittsburgh	Pennsylvania
United States	Main Medical Center	Portland	Maine

Sponsors (2)

Lead Sponsor	Collaborator
Jon Rittenberger, MD	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Awakening (Number of Patients Who Are Able to Follow Commands)	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	Time to Awakening	Defined as the time from enrollment to awakening	up to 28 days
Secondary	Seizures (Number of Patients Who Experience Seizures as Detected by EEG Monitoring With or Without Clinical Correlate)	detected by EEG monitoring with or without clinical correlate	during study drug administration (7 days)
Secondary	Nausea or Vomiting	nausea requiring antiemetic medications or clinical vomiting	during study drug administration (7 days)
Secondary	Number of Participants With Severe or Intracranial Bleeding	Bleeding that does not stop with direct pressure, requires transfusion, or occurs in the intracranial vault	28 days