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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02486211
Other study ID # 15GRNT25680021
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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