NCT02486211

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2015

Typical duration for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 1, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

December 4, 2019

Completed
Last Updated

December 4, 2019

Status Verified

November 1, 2019

Enrollment Period

2.8 years

First QC Date

June 23, 2015

Results QC Date

June 28, 2019

Last Update Submit

November 18, 2019

Conditions

ComaHeart ArrestAnoxia

Keywords

heart arrestresuscitationseizureshypothermia, inducedAmantadine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Time to Awakening

    up to 28 days

  • Seizures (Number of Patients Who Experience Seizures as Detected by EEG Monitoring With or Without Clinical Correlate)

    during study drug administration (7 days)

  • Nausea or Vomiting

    during study drug administration (7 days)

  • Number of Participants With Severe or Intracranial Bleeding

    28 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo medication administered at 0600 and 1200 via mouth, gastric tube or duo-tube.

Drug: Placebo

Amantadine

EXPERIMENTAL

100mg Amantadine administered at 0600 and 1200 via mouth, gastric tube or duo-tube.

Drug: Amantadine

Interventions

AmantadineDRUG

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

Also known as: Symmetrel
Amantadine
PlaceboDRUG

Placebo comparator

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non traumatic cardiac arrest
  • Age 18 and older
  • Defibrillation and/or chest compressions by healthcare providers
  • Return of spontaneous circulation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Main Medical Center

Portland, Maine, 04101, United States

Location

Beth Israel Deacconness

Boston, Massachusetts, 02215, United States

Location

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15216, United States

Location

UPMC Mercy Hospital

Pittsburgh, Pennsylvania, 15219, United States

Location

MeSH Terms

Conditions

ComaHeart ArrestHypoxiaSeizuresHypothermia

Interventions

Amantadine

Condition Hierarchy (Ancestors)

UnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular DiseasesSigns and Symptoms, RespiratoryBody Temperature Changes

Intervention Hierarchy (Ancestors)

AdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Dr. Jon Rittenberger
Organization
University of Pittsburgh
rittjc@upmc.edu
4126479489

Study Officials

  • Jon C Rittenberger, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Emergency Medicine

Study Record Dates

First Submitted

June 23, 2015

First Posted

July 1, 2015

Study Start

September 1, 2015

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

December 4, 2019

Results First Posted

December 4, 2019

Record last verified: 2019-11

Locations

US(4)