Trial Outcomes & Findings for Metoclopramide for Post Traumatic Headache (NCT NCT03220958)

NCT ID: NCT03220958

Last Updated: 2021-11-09

Results Overview

Improvement in this 0 to 10 verbal rating scale

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 160 participants
• Primary outcome timeframe: 1 hour after medication administration
• Results posted on: 2021-11-09

Participant Flow

Participant milestones

Measure	Metoclopramide Metoclopramide 20mg + diphenhydramine 25mg + 100cc normal saline, administered as an intravenous drip Metoclopramide: Metoclopramide 20mg Diphenhydramine: Diphenhydramine 25mg Normal saline: 100ml normal saline	Placebo Normal saline, administered as an intravenous drip Normal saline: 100ml normal saline
Overall Study STARTED	81	79
Overall Study COMPLETED	81	79
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Metoclopramide n=81 Participants Metoclopramide 20mg + diphenhydramine 25mg + 100cc normal saline, administered as an intravenous drip Metoclopramide: Metoclopramide 20mg Diphenhydramine: Diphenhydramine 25mg Normal saline: 100ml normal saline	Placebo n=79 Participants Normal saline, administered as an intravenous drip Normal saline: 100ml normal saline	Total n=160 Participants Total of all reporting groups
Age, Continuous	43 years STANDARD_DEVIATION 16 • n=81 Participants	46 years STANDARD_DEVIATION 17 • n=79 Participants	45 years STANDARD_DEVIATION 16 • n=160 Participants
Sex: Female, Male Female	51 Participants n=81 Participants	56 Participants n=79 Participants	107 Participants n=160 Participants
Sex: Female, Male Male	30 Participants n=81 Participants	23 Participants n=79 Participants	53 Participants n=160 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	81 participants n=81 Participants	79 participants n=79 Participants	160 participants n=160 Participants
Baseline pain intensity, as measured on a 0-10 scale	8.3 units on a scale STANDARD_DEVIATION 1.6 • n=81 Participants	8.3 units on a scale STANDARD_DEVIATION 1.5 • n=79 Participants	8.3 units on a scale STANDARD_DEVIATION 1.6 • n=160 Participants

PRIMARY outcome

Timeframe: 1 hour after medication administration

Improvement in this 0 to 10 verbal rating scale

Outcome measures

Measure	Metoclopramide n=81 Participants Metoclopramide 20mg + diphenhydramine 25mg + 100cc normal saline, administered as an intravenous drip Metoclopramide: Metoclopramide 20mg Diphenhydramine: Diphenhydramine 25mg Normal saline: 100ml normal saline	Placebo n=79 Participants Normal saline, administered as an intravenous drip Normal saline: 100ml normal saline
0-10 Pain Scale on Which 0 = no Pain and 10= the Worst Pain Imaginable	5.2 units on a scale Standard Deviation 2.3	3.8 units on a scale Standard Deviation 2.6

SECONDARY outcome

Timeframe: 48 hours after medication administration

Achieving a headache intensity of mild or none in the ED without use of rescue medication and maintaining a level of mild or none. Participants rate their headache as none, mild, moderate, or severe

Outcome measures

Measure	Metoclopramide n=78 Participants Metoclopramide 20mg + diphenhydramine 25mg + 100cc normal saline, administered as an intravenous drip Metoclopramide: Metoclopramide 20mg Diphenhydramine: Diphenhydramine 25mg Normal saline: 100ml normal saline	Placebo n=76 Participants Normal saline, administered as an intravenous drip Normal saline: 100ml normal saline
Sustained Headache Relief	24 Participants	18 Participants

SECONDARY outcome

Timeframe: 7 days after ED visit

Number of days with any headache. Participants report the actual number of days they experienced headache. A "day" begins when they awake for the beginning of daily activities and ends when they go to sleep after completion of daily activities

Outcome measures

Measure	Metoclopramide n=76 Participants Metoclopramide 20mg + diphenhydramine 25mg + 100cc normal saline, administered as an intravenous drip Metoclopramide: Metoclopramide 20mg Diphenhydramine: Diphenhydramine 25mg Normal saline: 100ml normal saline	Placebo n=71 Participants Normal saline, administered as an intravenous drip Normal saline: 100ml normal saline
Headache Days	3.3 days Standard Deviation 1.6	3.3 days Standard Deviation 1.6

Adverse Events

Metoclopramide

Serious events: 0 serious events

Other events: 35 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Metoclopramide n=81 participants at risk Metoclopramide 20mg + diphenhydramine 25mg + 100cc normal saline, administered as an intravenous drip Metoclopramide: Metoclopramide 20mg Diphenhydramine: Diphenhydramine 25mg Normal saline: 100ml normal saline	Placebo n=79 participants at risk Normal saline, administered as an intravenous drip Normal saline: 100ml normal saline
Nervous system disorders Drowsiness	18.5% 15/81 • Number of events 15 • 48 hours	10.1% 8/79 • Number of events 8 • 48 hours
Nervous system disorders Akathisia	6.2% 5/81 • 48 hours	0.00% 0/79 • 48 hours
Nervous system disorders Dizziness	4.9% 4/81 • 48 hours	1.3% 1/79 • 48 hours
Gastrointestinal disorders Diarrhea	2.5% 2/81 • 48 hours	1.3% 1/79 • 48 hours
Nervous system disorders Post-concussive syndrome	8.6% 7/81 • 48 hours	6.3% 5/79 • 48 hours
Investigations Various other	2.5% 2/81 • 48 hours	8.9% 7/79 • 48 hours

Additional Information

Benjamin Friedman

Montefiore

Phone: 718-920-6626

Email: befriedm@montefiore.org

Results disclosure agreements

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