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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo medication administered at 0600 and 1200 via mouth, gastric tube or duo-tube. |
|
| Amantadine | Experimental | 100mg Amantadine administered at 0600 and 1200 via mouth, gastric tube or duo-tube. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amantadine | Drug | 100mg twice per day for 7 days at 0600 and 1200 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Awakening | Defined as the time from enrollment to awakening | up to 28 days |
| Seizures (Number of Patients Who Experience Seizures as Detected by EEG Monitoring With or Without Clinical Correlate) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon C Rittenberger, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Main Medical Center | Portland | Maine | 04101 | United States | ||
| Beth Israel Deacconness |
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| ID | Title | Description |
|---|---|---|
| FG000 | Amantadine | 100mg Amantadine administered at 0600 and 1200 via mouth, gastric tube or duo-tube. Amantadine: 100mg twice per day for 7 days at 0600 and 1200 |
| FG001 | Placebo | Placebo medication administered at 0600 and 1200 via mouth, gastric tube or duo-tube. Placebo: Placebo comparator |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo medication administered at 0600 and 1200 via mouth, gastric tube or duo-tube. Placebo: Placebo comparator |
| BG001 | Amantadine | 100mg Amantadine administered at 0600 and 1200 via mouth, gastric tube or duo-tube. Amantadine: 100mg BID for 7 days at 0600 and 1200 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | up to 28 days |
|
7 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Amantadine | 100mg Amantadine administered at 0600 and 1200 via mouth, gastric tube or duo-tube. Amantadine: 100mg BID for 7 days at 0600 and 1200 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tongue swelling | Gastrointestinal disorders | Non-systematic Assessment | Tongue swelling secondary to tongue bite. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jon Rittenberger | University of Pittsburgh | 4126479489 | rittjc@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 28, 2019 | Jul 25, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003128 | Coma |
| D006323 | Heart Arrest |
| D000860 | Hypoxia |
| D012640 | Seizures |
| D007035 | Hypothermia |
| ID | Term |
|---|---|
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D000547 | Amantadine |
| ID | Term |
|---|---|
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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| Placebo | Drug | Placebo comparator |
|
detected by EEG monitoring with or without clinical correlate
| during study drug administration (7 days) |
| Nausea or Vomiting | nausea requiring antiemetic medications or clinical vomiting | 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 | 28 days |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| UPMC Presbyterian Hospital | Pittsburgh | Pennsylvania | 15216 | United States |
| UPMC Mercy Hospital | Pittsburgh | Pennsylvania | 15219 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Time to Awakening | Defined as the time from enrollment to awakening | Posted | Median | Inter-Quartile Range | days | 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 | Posted | Count of Participants | Participants | during study drug administration (7 days) |
|
|
|
| Secondary | Nausea or Vomiting | nausea requiring antiemetic medications or clinical vomiting | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 28 days |
|
|
|
| 4 |
| 7 |
| 0 |
| 7 |
| 1 |
| 7 |
| EG001 | Placebo | Placebo medication administered at 0600 and 1200 via mouth, gastric tube or duo-tube. Placebo: Placebo comparator | 3 | 7 | 0 | 7 | 2 | 7 |
|
| seizure | Nervous system disorders | Non-systematic Assessment | seizure |
|
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| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D001832 | Body Temperature Changes |
| D009930 |
| Organic Chemicals |