ComaPhase 2AWAKENCT02486211
Amantadine to Speed Awakening After Cardiac Arrest
A Phase 2 study testing Amantadine in people with Coma and Heart Arrest, run by Jon Rittenberger, MD at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coma, Heart Arrest, Anoxia
- What is being tested?
- Amantadine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2015to 30 Jun 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non traumatic cardiac arrest
- Age 18 and older
- Defibrillation and/or chest compressions by healthcare providers
- Return of spontaneous circulation
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Beth Israel Deacconness
Boston, Massachusetts, 02215
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15216
UPMC Mercy Hospital
Pittsburgh, Pennsylvania, 15219
Main Medical Center
Portland, Maine, 04101
About this study
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.
Read the 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.
- Conditions
- Coma, Heart Arrest, Anoxia
- Being tested
- Amantadine, Placebo
- Keywords
- heart arrest, resuscitation, seizures, hypothermia, induced, Amantadine
- Medical subject headings
- Coma, Heart Arrest, Hypoxia, Seizures, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmantadineDrug
Also called Symmetrel
100mg twice per day for 7 days at 0600 and 1200
PlaceboDrug
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo medication administered at 0600 and 1200 via mouth, gastric tube or duo-tube. Receives: Drug: Placebo |
| Amantadine | Experimental | 100mg Amantadine administered at 0600 and 1200 via mouth, gastric tube or duo-tube. Receives: Drug: Amantadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 28 days
Secondary outcomes (4)
Time to Awakening
Defined as the time from enrollment to awakening
Measured: up to 28 days
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
Measured: during study drug administration (7 days)
Nausea or Vomiting
nausea requiring antiemetic medications or clinical vomiting
Measured: during study drug administration (7 days)
Number of Participants With Severe or Intracranial Bleeding
Bleeding that does not stop with direct pressure, requires transfusion, or occurs in the intracranial vault
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startSep 2015
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ComaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jon Rittenberger, MD
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor-investigator, Jon Rittenberger, MD, University of Pittsburgh
- Investigators
- Jon C Rittenberger, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02486211
- Sponsor's protocol ID
- 15GRNT25680021
- Acronym
- AWAKE
- Status last verified
- Nov 2019
- First submitted
- 23 Jun 2015
- Last updated
- 4 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amantadine to Speed Awakening After Cardiac Arrest
- ClinicalTrials.gov ID
- NCT02486211
- Acronym / sponsor ID
- AWAKE / 15GRNT25680021
- Conditions
- Coma, Heart Arrest, Anoxia
- Keywords
- heart arrest, resuscitation, seizures, hypothermia, induced, Amantadine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Jon Rittenberger, MDUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Sep 2015
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 1 Jul 2015 (estimated)
- Results
- Posted 4 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo medication administered at 0600 and 1200 via mouth, gastric tube or duo-tube. |
| Amantadine | Experimental | Drug: Amantadine100mg Amantadine administered at 0600 and 1200 via mouth, gastric tube or duo-tube. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Non traumatic cardiac arrest
- Age 18 and older
- Defibrillation and/or chest compressions by healthcare providers
- Return of spontaneous circulation
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmantadineAlso: Symmetrel100mg twice per day for 7 days at 0600 and 1200 | Drug | Amantadine |
| PlaceboPlacebo comparator | Drug | Placebo |
Primary outcome
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.
4 secondary outcomes
Time to Awakening
Time frame: 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)
Nausea or Vomiting
Time frame: during study drug administration (7 days)
Number of Participants With Severe or Intracranial Bleeding
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Coma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jon C Rittenberger, MD principal investigator
University of Pittsburgh
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amantadine in people with Coma and Heart Arrest, run by Jon Rittenberger, MD at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Awakening (Number of Patients Who Are Able to Follow Commands) (time frame: up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2019.