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Acute Cerebrovascular Accident | Histamine Glutamate Antagonism in Stroke

Acute Cerebrovascular Accident research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: 1. Subjects with age ≥18 years and ≤80 years at the time of screening. 2. All Ischemic stroke patients with clinical and or radiological diagnosis. 3. Subjects who have presented to hospital within 6 hours of symptom onset. 4. The subject or his/ her legal representative is willing to undergo informed consent process prior to enrollment into this study. Exclusion Criteria: 1. Subject with age < 18 years and >80 years at the time of screening. 2. Time of symptom onset cannot be determined. 3. Subject who is pregnant or lactating. 4. Subject who has asthma exacerbations in past 3 months. 5. Subject who has hypersensitivity to dextromethorphan, diphenhydramine or famotidine, or other H2 antagonists or any component of the formulation. 6. Serotonin syndrome. 7. Concurrent administration with or within 2 weeks of discontinuing an MAO inhibitor 8. Subjects with renal or hepatic failure. 9. The subject or legal representative is unable to provide informed consent. 10. The subject is medically unstable to participate in the trial as determined by the principal investigator. 11. The subject has any end stage medical condition as determined by the principal investigator.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Acute Cerebrovascular Accident

Cerebral Edema

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:DiphenhydramineDiphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.

Drug:PantoprazolePantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care.

Drug:FamotidineFamotidine 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.

Drug:DextromethorphanDextromethorphan 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

PantoprazolePantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care.

FamotidineFamotidine 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.

DextromethorphanDextromethorphan 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.

DiphenhydramineDiphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.

Study Status

Completed

Start Date: December 2014

Completed Date: December 2014

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Modified Rankin Score

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Vishnumurthy S Hedna, MD

Lead Sponsor: University of Florida

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02142712

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