Trial Outcomes & Findings for Histamine Glutamate Antagonism in Stroke (NCT NCT02142712)

Results Overview

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 1. No significant disability despite symptoms; able to carry out all usual duties and activities 2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. Moderate disability; requiring some help, but able to walk without assistance 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. Dead

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

8 days and 3 months from the baseline

Results posted on

2015-12-15

Participant Flow

Participants were recruited at Shands Hospital.

Participant milestones

Participant milestones
Measure	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.	Pantoprazole Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care	Diphenhydramine Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.
Overall Study STARTED	1	1	1
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	1	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	Pantoprazole Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care	Diphenhydramine Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days 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) + current standard of care
Overall Study Lost to Follow-up	1	1	1	0

Baseline Characteristics

Histamine Glutamate Antagonism in Stroke

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Famotidine n=1 Participants 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.	Pantoprazole n=1 Participants Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care	Diphenhydramine n=1 Participants Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment United States	1 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	3 participants n=4 Participants

PRIMARY outcome

Timeframe: 8 days and 3 months from the baseline

Population: The data was not collected since the participants did not come back for follow-ups.

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 1. No significant disability despite symptoms; able to carry out all usual duties and activities 2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. Moderate disability; requiring some help, but able to walk without assistance 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. Dead

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline

Population: NIHSS data was only collected for the baseline visit, since the participants did not come back for follow-ups.

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.

Outcome measures

Outcome measures
Measure	Famotidine n=1 Participants 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.	Pantoprazole n=1 Participants Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care	Diphenhydramine n=1 Participants Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.
National Institutes of Health Stroke Severity (NIHSS) Scale	3 NIHSS scale	3 NIHSS scale	0 NIHSS scale

PRIMARY outcome

Timeframe: Baseline

Population: Data was collected only for the baseline visit, since the participants did not come back for follow-ups.

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).

Outcome measures

Outcome measures
Measure	Famotidine n=1 Participants 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.	Pantoprazole n=1 Participants Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care	Diphenhydramine n=1 Participants Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.
Glasgow Coma Scale (GCS)	15 Glasgow Coma Scale	15 Glasgow Coma Scale	15 Glasgow Coma Scale

PRIMARY outcome

Timeframe: At 3 months from baseline

Population: The data was not collected since the participants did not come back for follow-ups.

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: 1. presence or absence of fecal incontinence 2. presence or absence of urinary incontinence 3. help needed with grooming 4. help needed with toilet use 5. help needed with feeding 6. help needed with transfers (e.g. from chair to bed) 7. help needed with walking 8. help needed with dressing 9. help needed with climbing stairs 10. help needed with bathing

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At 3 months from baseline

Population: The data was not collected since the participants did not come back for follow-ups.

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.

Outcome measures

Outcome data not reported

Adverse Events

Famotidine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pantoprazole

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Diphenhydramine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Vishnumurthy Shushrutha Hedna

University of New Mexico - Neurology Department

Phone: 505-272-3342

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place