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Stroke is the 4th leading cause of death in United States with an estimated 1 death every 4 minutes. On average, someone suffers from stroke in United States every 40th second. Stroke recurs in 1 out of 4 stroke patients. About 87% of the strokes are as a result of ischemic insult. The total economic burden from stroke accounts to 38.6 billion dollars per year. Stroke is also one of the leading causes of long term disability. Current stroke therapies concentrate mainly on acute revascularization, sub-acute rehabilitation and secondary prevention.
Neuroprotection is not the mainstay of treatment modality as there are no effective regimen which has satisfied stroke clinicians and researchers. Many neuroprotection agents have shown excellent pre-clinical results but have failed in clinical translation. Thus we need to find new treatments in order to decrease the mortality and morbidity caused by stroke.
The investigators hypothesize that adopting a narrower therapeutic window, with treatment initiation in the first six hours, may demonstrate a positive or significant short and long term neuroprotective effect from NMDA/Glutaminergic or histaminergic antagonism when compared with standard of care.
If the subject decides to take part in this study, the subject will be placed randomly in the treatment group or the standard of care group. This means:
The subject will be given either the treatment drugs with standard of care for stroke or only standard of care. If the subject is placed in the treatment group the subject will be again randomly administered either diphenhydramine oral or through an injection in the vein for 4 days or dextromethorphan tablet orally for 2 days. In the treatment group the subject will receive another drug named famotidine through an injection in vein as a prophylaxis to prevent any gastrointestinal bleeding or ulceration whereas in the standard of care group the subject will receive pantoprazole through an injection in the vein for the same purpose. If the subject cannot take medication orally then we will put a tube through the nose to the subject's stomach or small intestine or we might also put a gastric tube directly into the subject's stomach surgically through a small cut in the belly. The investigators will collect information for the medical charts to include: imaging data, stroke assessments and medical history. A neurological exam will done, called the National Institutes of Health Stroke Scale (NIHSS). It is used to assess the neurologic damage caused by stroke. A Modified Rankin Scale (m-RS) will also be performed and this is a scale used to measure the degree of disability or dependence in the daily activities after a stroke.
The subject will be asked to come for a follow-up at 3 months after the discharge from the hospital and the following will be done:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pantoprazole | Active Comparator | Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care. |
|
| Famotidine | Active Comparator | Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care. |
|
| Dextromethorphan | Experimental | Dextromethorphan 60 mg QID orally (maximum dose of 240 mg/day) for 2 days (total of 4 doses) along with current standard of care. If the drug can't be given orally, then feeding tube (G-tube, NG Tube or DHT) will be used for drug administration. |
|
| Diphenhydramine | Experimental | Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diphenhydramine | Drug | Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Modified Rankin Score | The modified Rankin Scale (m-RS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people after they have suffered a stroke.It is one of the most widely used clinical outcome measure for stroke clinical trials. The score is given according to following scale. 0- No symptoms at all
| 8 days and 3 months from the baseline |
| National Institutes of Health Stroke Severity (NIHSS) Scale | NIHSS is a tool used by healthcare providers to objectively quantify the degree of impairment caused by a stroke. It is composed of 11 items. Each item scores a specific ability between a score of 0-4. Usually, for each item, a score of 0 indicates normal function in that specific ability, while a higher score indicates some level of impairment. The individual scores from each item are added together to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0. | Baseline |
| Glasgow Coma Scale (GCS) | Glasgow Coma Scale (GCS) is assessed by physical neurological examination of the subject by a qualified neurologist. GSC is a common scoring system used to describe the level of consciousness in a person following a traumatic brain injury. The initial score correlates with the severity of brain injury and prognosis. It estimates Coma severity based on Eye (4), Verbal (5), and Motor (6) criteria with the following total score of between 3 (indicating deep unconsciousness) and 15 (indicating no issues). | Baseline |
| Barthel Index |
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| Measure | Description | Time Frame |
|---|---|---|
| CT or MRI of Head Without Contrast | MRI of head or CT head done as part of your follow up care at 3 months. This will give us the information about the effect of dextromethorphan effect on the final brain damage from stroke. | At 3 months from baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vishnumurthy S Hedna, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shands Hospital at University of Florida | Gainesville | Florida | 32610 | United States |
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Participants were recruited at Shands Hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Famotidine | Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care. |
| FG001 | Pantoprazole | Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care |
| FG002 | Diphenhydramine | Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care. |
| FG003 | Dextromethorphan | Dextromethorphan- 60 mg QID orally (maximum dose of 240 mg/day) for 2 days (total of 4 doses) + current standard of care |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Famotidine | Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care. |
| BG001 | Pantoprazole |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Modified Rankin Score | The modified Rankin Scale (m-RS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people after they have suffered a stroke.It is one of the most widely used clinical outcome measure for stroke clinical trials. The score is given according to following scale. 0- No symptoms at all
| The data was not collected since the participants did not come back for follow-ups. | Posted | 8 days and 3 months from the baseline |
|
Up to month 3 from the baseline visit
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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 | Famotidine | Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Vishnumurthy Shushrutha Hedna | University of New Mexico - Neurology Department | 505-272-3342 | Drshushrutha@gmail.com |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D001929 | Brain Edema |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004155 | Diphenhydramine |
| D000077402 | Pantoprazole |
| D015738 | Famotidine |
| D003915 | Dextromethorphan |
| D000086 | Acetazolamide |
| ID | Term |
|---|---|
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D001559 | Benzhydryl Compounds |
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| Pantoprazole | Drug | Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care. |
|
|
| Famotidine | Drug | Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care. |
|
|
| Dextromethorphan | Drug | Dextromethorphan 60 mg QID orally (maximum dose of 240 mg/day) for 2 days (total of 4 doses) along with current standard of care. If the drug can't be given orally, then feeding tube (G-tube, NG Tube or DHT) will be used for drug administration. |
|
|
It is an ordinal scale used to measure performance in activities of daily living (ADL). Each performance item is rated on this scale with a given number of points assigned to each level or ranking. It uses ten variables describing ADL and mobility. A higher number is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital. It yields a score of 0-20. The ten variables addressed in the Barthel scale are:
|
| At 3 months from baseline |
Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care
| BG002 | Diphenhydramine | Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Famotidine |
Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care. |
| OG001 | Pantoprazole | Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care |
| OG002 | Diphenhydramine | Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care. |
|
| Primary | National Institutes of Health Stroke Severity (NIHSS) Scale | NIHSS is a tool used by healthcare providers to objectively quantify the degree of impairment caused by a stroke. It is composed of 11 items. Each item scores a specific ability between a score of 0-4. Usually, for each item, a score of 0 indicates normal function in that specific ability, while a higher score indicates some level of impairment. The individual scores from each item are added together to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0. | NIHSS data was only collected for the baseline visit, since the participants did not come back for follow-ups. | Posted | Number | NIHSS scale | Baseline |
|
|
|
| Primary | Glasgow Coma Scale (GCS) | Glasgow Coma Scale (GCS) is assessed by physical neurological examination of the subject by a qualified neurologist. GSC is a common scoring system used to describe the level of consciousness in a person following a traumatic brain injury. The initial score correlates with the severity of brain injury and prognosis. It estimates Coma severity based on Eye (4), Verbal (5), and Motor (6) criteria with the following total score of between 3 (indicating deep unconsciousness) and 15 (indicating no issues). | Data was collected only for the baseline visit, since the participants did not come back for follow-ups. | Posted | Number | Glasgow Coma Scale | Baseline |
|
|
|
| Primary | Barthel Index | It is an ordinal scale used to measure performance in activities of daily living (ADL). Each performance item is rated on this scale with a given number of points assigned to each level or ranking. It uses ten variables describing ADL and mobility. A higher number is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital. It yields a score of 0-20. The ten variables addressed in the Barthel scale are:
| The data was not collected since the participants did not come back for follow-ups. | Posted | At 3 months from baseline |
|
|
| Other Pre-specified | CT or MRI of Head Without Contrast | MRI of head or CT head done as part of your follow up care at 3 months. This will give us the information about the effect of dextromethorphan effect on the final brain damage from stroke. | The data was not collected since the participants did not come back for follow-ups. | Posted | At 3 months from baseline |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Pantoprazole | Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care | 0 | 1 | 0 | 1 |
| EG002 | Diphenhydramine | Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care. | 0 | 1 | 0 | 1 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D013830 | Thiadiazoles |