Phase 2
N=3
Histamine Glutamate Antagonism in Stroke
Acute Cerebrovascular Accident · Cerebral Edema
Bottom Line
View on ClinicalTrials.gov: NCT02142712 ↗Enrolled (actual)
3
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcome: Primary: Modified Rankin Score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Diphenhydramine (Drug); Pantoprazole (Drug); Famotidine (Drug); Dextromethorphan (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Modified Rankin Score |
— | — |
| PRIMARY National Institutes of Health Stroke Severity (NIHSS) Scale |
3; 3; 0 | — |
| PRIMARY Glasgow Coma Scale (GCS) |
15; 15; 15 | — |
| PRIMARY Barthel Index |
— | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- Subject with age 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.
Data sourced from ClinicalTrials.gov (NCT02142712). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.