Trial Outcomes & Findings for Metoclopramide for Post-Traumatic Headache. A Pilot Study (NCT NCT03056352)

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 medication administration.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

21 participants

Primary outcome timeframe

2 hours thru 48 hours after treatment

Results posted on

2018-07-31

Participant Flow

Participant milestones

Participant milestones
Measure	Metoclopramide Metoclopramide 20mg + diphenhydramine 25mg administered intravenously over 15 minutes Metoclopramide: Intravenous medication drip Diphenhydramine: Intravenous medication drip
Overall Study STARTED	21
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Metoclopramide Metoclopramide 20mg + diphenhydramine 25mg administered intravenously over 15 minutes Metoclopramide: Intravenous medication drip Diphenhydramine: Intravenous medication drip
Overall Study Lost to Follow-up	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Metoclopramide n=21 Participants Metoclopramide 20mg + diphenhydramine 25mg administered intravenously over 15 minutes Metoclopramide: Intravenous medication drip Diphenhydramine: Intravenous medication drip
Age, Continuous	45 years STANDARD_DEVIATION 18 • n=21 Participants
Sex: Female, Male Female	16 Participants n=21 Participants
Sex: Female, Male Male	5 Participants n=21 Participants
Region of Enrollment United States	21 participants n=21 Participants

PRIMARY outcome

Timeframe: 2 hours thru 48 hours after treatment

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 medication administration.

Outcome measures

Outcome measures
Measure	Metoclopramide n=20 Participants Metoclopramide 20mg + diphenhydramine 25mg administered intravenously over 15 minutes Metoclopramide: Intravenous medication drip Diphenhydramine: Intravenous medication drip
Number of Participants With Sustained Headache Relief	12 Participants

SECONDARY outcome

Timeframe: 7 days

Population: 2 patients were lost to followup

The post-concussive symptom scale is a questionnaire administered verbally. The post-concussive symptom ranges from 0 to 132. 0= no post-concussive symptoms. 132= severe post-concussive symptoms.

Outcome measures

Outcome measures
Measure	Metoclopramide n=19 Participants Metoclopramide 20mg + diphenhydramine 25mg administered intravenously over 15 minutes Metoclopramide: Intravenous medication drip Diphenhydramine: Intravenous medication drip
Post Concussion Symptoms Assessed by Post-concussive Symptom Scale	11.4 units on a scale Standard Deviation 21.4

SECONDARY outcome

Timeframe: 48 hours after treatment

Population: 2 patients did not provide an answer to this question

Satisfaction is measured by a positive response to the question "Would you want to receive the same medication during a subsequent visit for post-traumatic headache?"

Outcome measures

Outcome measures
Measure	Metoclopramide n=19 Participants Metoclopramide 20mg + diphenhydramine 25mg administered intravenously over 15 minutes Metoclopramide: Intravenous medication drip Diphenhydramine: Intravenous medication drip
Number of Participants Satisfied With Medication; Assessed by Self-evaluation	16 Participants

Adverse Events

Metoclopramide

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Metoclopramide n=21 participants at risk Metoclopramide 20mg + diphenhydramine 25mg administered intravenously over 15 minutes Metoclopramide: Intravenous medication drip Diphenhydramine: Intravenous medication drip
Nervous system disorders Drowsiness	9.5% 2/21 • Number of events 2 • Data on adverse events was collected every two hours while in the Emergency Department and then by telephone 48 hours after discharge

Additional Information

Benjamin W. Friedman, MD

Montefiore Health

Phone: 718-920-6626

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place