Trial · NCT02486211
Amantadine to Speed Awakening After Cardiac Arrest
NCT02486211, Phase 2, Completed, Jon Rittenberger, MD; results first posted 2019-12-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Amantadine to Speed Awakening After Cardiac Arrest. Trials, record NCT02486211. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02486211
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Amantadine to Speed Awakening After Cardiac Arrest
- NCT number
- NCT02486211
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 14 participants, actual
- Lead sponsor
- Jon Rittenberger, MD
- Conditions
- Coma, Heart Arrest, Anoxia
- Interventions
- Amantadine, Placebo
- First posted
- 2015-07-01
- Last updated
- 2019-12-04
- Results first posted
- 2019-12-04
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Awakening (Number of Patients Who Are Able to Follow Commands) | 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 | Time to Awakening | up to 28 days | Defined as the time from enrollment to awakening |
| Secondary | Seizures (Number of Patients Who Experience Seizures as Detected by EEG Monitoring With or Without Clinical Correlate) | during study drug administration (7 days) | detected by EEG monitoring with or without clinical correlate |
| Secondary | Nausea or Vomiting | during study drug administration (7 days) | nausea requiring antiemetic medications or clinical vomiting |
| Secondary | Number of Participants With Severe or Intracranial Bleeding | 28 days | Bleeding that does not stop with direct pressure, requires transfusion, or occurs in the intracranial vault |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Rate of Awakening (Number of Patients Who Are Able to Follow Commands) | up to 28 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to Awakening | up to 28 days | days | MEDIAN | |
| SECONDARY | Seizures (Number of Patients Who Experience Seizures as Detected by EEG Monitoring With or Without Clinical Correlate) | during study drug administration (7 days) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Nausea or Vomiting | during study drug administration (7 days) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Severe or Intracranial Bleeding | 28 days | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Rate of Awakening (Number of Patients Who Are Able to Follow Commands) | Amantadine | 2 | Participants | ||
| Rate of Awakening (Number of Patients Who Are Able to Follow Commands) | Placebo | 2 | Participants | ||
| Time to Awakening | Amantadine | 4 | Inter-Quartile Range 4 to 4 | days | |
| Time to Awakening | Placebo | 8 | Inter-Quartile Range 2 to 14 | days | |
| Seizures (Number of Patients Who Experience Seizures as Detected by EEG Monitoring With or Without Clinical Correlate) | Amantadine | 0 | Participants | ||
| Seizures (Number of Patients Who Experience Seizures as Detected by EEG Monitoring With or Without Clinical Correlate) | Placebo | 2 | Participants | ||
| Nausea or Vomiting | Amantadine | 0 | Participants | ||
| Nausea or Vomiting | Placebo | 0 | Participants | ||
| Number of Participants With Severe or Intracranial Bleeding | Amantadine | 0 | Participants | ||
| Number of Participants With Severe or Intracranial Bleeding | Placebo | 0 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Amantadine | 7 | |
| Overall Study | STARTED | Placebo | 7 | |
| Overall Study | COMPLETED | Amantadine | 6 | |
| Overall Study | COMPLETED | Placebo | 7 | |
| Overall Study | NOT COMPLETED | Amantadine | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Tongue swelling | Gastrointestinal disorders | Amantadine | 1 | 7 | 1 |
| other | Tongue swelling | Gastrointestinal disorders | Placebo | 0 | 7 | 0 |
| other | seizure | Nervous system disorders | Amantadine | 0 | 7 | 0 |
| other | seizure | Nervous system disorders | Placebo | 2 | 7 | 2 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Amantadine | 4 | 7 |
| Total, all-cause mortality | Placebo | 3 | 7 |
| Total, other adverse events | Amantadine | 1 | 7 |
| Total, other adverse events | Placebo | 2 | 7 |
| Total, serious adverse events | Amantadine | 0 | 7 |
| Total, serious adverse events | Placebo | 0 | 7 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Amantadine vs Placebo: Nausea or Vomiting | Trial comparisons |
| Amantadine vs Placebo: Rate of Awakening (Number of Patients Who Are Able to Follow Commands) | Trial comparisons |
| Amantadine vs Placebo: Number of Participants With Severe or Intracranial Bleeding | Trial comparisons |
| Amantadine vs Placebo: Seizures (Number of Patients Who Experience Seizures as Detected by EEG Monitoring With or Without Clinical Correlate) | Trial comparisons |
| Amantadine vs Placebo: deaths from any cause | Trial comparisons |
| Amantadine vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02486211
GET https://conductscience.org/api/trials/v1/NCT02486211/registered