Trial Outcomes & Findings for Diphenhydramine for Acute Migraine (NCT NCT01825941)

NCT ID: NCT01825941

Last Updated: 2018-07-31

Results Overview

Sustained headache relief is defined as achieving a headache level of "mild" or "none" within two hours and maintaining a level of "mild" or "none" for 48 hours. Patient self-evaluated pain level is solicited every half hour for two hours in the Emergency Department and then by telephone 48 hours after discharge from emergency department

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 208 participants
• Primary outcome timeframe: up to 2 hours in Emergency Department, 48 hours after discharge from Emergency Department
• Results posted on: 2018-07-31

Participant Flow

Protocol anticipated enrollment of around 400 participants, however Data Safety Monitoring Board recommended enrollment cut to approximately half

Participant milestones

Measure	Metoclopramide + Diphenhydramine Metoclopramide 10 milligrams + Diphenhydramine 50 milligrams, administered as an intravenous drip over 15 minutes metoclopramide: 10 milligrams, administered intravenously over 15 minutes diphenhydramine: 50 milligrams, administered intravenously over 15 minutes	Metoclopramide + Placebo Metoclopramide 10mg + placebo, administered intravenously over 15 minutes metoclopramide: 10 milligrams, administered intravenously over 15 minutes placebo
Overall Study STARTED	104	104
Overall Study COMPLETED	100	103
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Measure	Metoclopramide + Diphenhydramine Metoclopramide 10 milligrams + Diphenhydramine 50 milligrams, administered as an intravenous drip over 15 minutes metoclopramide: 10 milligrams, administered intravenously over 15 minutes diphenhydramine: 50 milligrams, administered intravenously over 15 minutes	Metoclopramide + Placebo Metoclopramide 10mg + placebo, administered intravenously over 15 minutes metoclopramide: 10 milligrams, administered intravenously over 15 minutes placebo
Overall Study Lost to Follow-up	4	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Metoclopramide + Diphenhydramine n=104 Participants Metoclopramide 10 milligrams + Diphenhydramine 50 milligrams, administered as an intravenous drip over 15 minutes metoclopramide: 10 milligrams, administered intravenously over 15 minutes diphenhydramine: 50 milligrams, administered intravenously over 15 minutes	Metoclopramide + Placebo n=104 Participants Metoclopramide 10mg + placebo, administered intravenously over 15 minutes metoclopramide: 10 milligrams, administered intravenously over 15 minutes placebo	Total n=208 Participants Total of all reporting groups
Age, Continuous	34 years STANDARD_DEVIATION 11 • n=104 Participants	36 years STANDARD_DEVIATION 10 • n=104 Participants	35 years STANDARD_DEVIATION 10 • n=208 Participants
Sex: Female, Male Female	88 Participants n=104 Participants	92 Participants n=104 Participants	180 Participants n=208 Participants
Sex: Female, Male Male	16 Participants n=104 Participants	12 Participants n=104 Participants	28 Participants n=208 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	104 Participants n=104 Participants	104 Participants n=104 Participants	208 Participants n=208 Participants
Duration of headache Prior to Study	72 Hours n=104 Participants	48 Hours n=104 Participants	48 Hours n=208 Participants

PRIMARY outcome

Timeframe: up to 2 hours in Emergency Department, 48 hours after discharge from Emergency Department

Sustained headache relief is defined as achieving a headache level of "mild" or "none" within two hours and maintaining a level of "mild" or "none" for 48 hours. Patient self-evaluated pain level is solicited every half hour for two hours in the Emergency Department and then by telephone 48 hours after discharge from emergency department

Outcome measures

Measure	Metoclopramide + Diphenhydramine n=100 Participants Metoclopramide 10 milligrams + Diphenhydramine 50 milligrams, administered as an intravenous drip over 15 minutes metoclopramide: 10 milligrams, administered intravenously over 15 minutes diphenhydramine: 50 milligrams, administered intravenously over 15 minutes	Metoclopramide + Placebo n=103 Participants Metoclopramide 10mg + placebo, administered intravenously over 15 minutes metoclopramide: 10 milligrams, administered intravenously over 15 minutes placebo
Number of Participants With Sustained Headache Relief Assessed by Self-evaluation	40 Participants	38 Participants

Adverse Events

Metoclopramide + Diphenhydramine

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Metoclopramide + Placebo

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Metoclopramide + Diphenhydramine n=104 participants at risk Metoclopramide 10 milligrams + Diphenhydramine 50 milligrams, administered as an intravenous drip over 15 minutes metoclopramide: 10 milligrams, administered intravenously over 15 minutes diphenhydramine: 50 milligrams, administered intravenously over 15 minutes	Metoclopramide + Placebo n=104 participants at risk；n=103 participants at risk Metoclopramide 10mg + placebo, administered intravenously over 15 minutes metoclopramide: 10 milligrams, administered intravenously over 15 minutes placebo
Nervous system disorders Restlessness	7.7% 8/104 • Number of events 8	6.7% 7/104 • Number of events 7
Nervous system disorders Drowsy	16.3% 17/104 • Number of events 17	13.5% 14/104 • Number of events 14

Additional Information

Benjamin W. Friedman, MD, MS

Montefiore Medical Center

Phone: 718-920-6266

Email: befriedm@montefiore.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place