Histamine Glutamate Antagonism in Stroke

Completed · Phase 2

Conditions studied: Acute Cerebrovascular Accident, Cerebral Edema

In brief

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.

Key facts

Study ID

NCT02142712

Run by

University of Florida

People needed

3

Starts

2014-12-01

Expected to finish

2014-12-01

Last updated by the study team

2015-12-15

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with age ≥18 years and ≤80 years at the time of screening.
• All Ischemic stroke patients with clinical and or radiological diagnosis.
• Subjects who have presented to hospital within 6 hours of symptom onset.
• The subject or his/ her legal representative is willing to undergo informed consent process prior to enrollment into this study.

You may not qualify if…

• Subject with age < 18 years and >80 years at the time of screening.
• Time of symptom onset cannot be determined.
• Subject who is pregnant or lactating.
• Subject who has asthma exacerbations in past 3 months.
• Subject who has hypersensitivity to dextromethorphan, diphenhydramine or famotidine, or other H2 antagonists or any component of the formulation.
• Serotonin syndrome.
• Concurrent administration with or within 2 weeks of discontinuing an MAO inhibitor
• Subjects with renal or hepatic failure.
• The subject or legal representative is unable to provide informed consent.
• The subject is medically unstable to participate in the trial as determined by the principal investigator.
• The subject has any end stage medical condition as determined by the principal investigator.

Where it is running

• Shands Hospital at University of Florida — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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