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Histamine Glutamate Antagonism in Stroke

NCT ID: NCT02142712

Last Updated: 2015-12-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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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:

1. Modified Rankin Scale (m-RS) scores NIH Stroke Scale scores
2. CT or MRI of the head without contrast

Conditions

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Acute Cerebrovascular Accident Cerebral Edema

Keywords

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Ischemic Stroke Brain Edema Diphenhydramine Dextromethorphan Famotidine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pantoprazole

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

Group Type ACTIVE_COMPARATOR

Pantoprazole

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Famotidine

Intervention Type 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

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.

Group Type EXPERIMENTAL

Famotidine

Intervention Type 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

Intervention Type 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.

Diphenhydramine

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

Group Type EXPERIMENTAL

Diphenhydramine

Intervention Type DRUG

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

Famotidine

Intervention Type 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.

Interventions

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Diphenhydramine

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

Intervention Type DRUG

Pantoprazole

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

Intervention Type DRUG

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.

Intervention Type DRUG

Dextromethorphan

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.

Intervention Type DRUG

Other Intervention Names

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Benadryl Protonix Pepcid Diamox

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vishnumurthy S Hedna, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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Shands Hospital at University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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201400353

Identifier Type: -

Identifier Source: org_study_id