Trial · NCT03220958

Metoclopramide for Post Traumatic Headache

NCT03220958, Phase 3, Completed, Montefiore Medical Center; results first posted 2021-11-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Metoclopramide for Post Traumatic Headache. Trials, record NCT03220958. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03220958

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Metoclopramide for Post Traumatic Headache
NCT number: NCT03220958
Status: Completed
Phases: Phase 3
Enrollment: 160 participants, actual
Lead sponsor: Montefiore Medical Center
Conditions: Post-Traumatic Headache
Interventions: Metoclopramide, Diphenhydramine, Normal saline
First posted: 2017-07-18
Last updated: 2021-11-09
Results first posted: 2021-11-09

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	0-10 Pain Scale on Which 0 = no Pain and 10= the Worst Pain Imaginable	1 hour after medication administration	Improvement in this 0 to 10 verbal rating scale
Secondary	Sustained Headache Relief	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
Secondary	Headache Days	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

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	0-10 Pain Scale on Which 0 = no Pain and 10= the Worst Pain Imaginable	1 hour after medication administration	units on a scale	MEAN
SECONDARY	Sustained Headache Relief	48 hours after medication administration	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Headache Days	7 days after ED visit	days	MEAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
0-10 Pain Scale on Which 0 = no Pain and 10= the Worst Pain Imaginable	Metoclopramide	5.2	Standard Deviation 2.3	units on a scale
0-10 Pain Scale on Which 0 = no Pain and 10= the Worst Pain Imaginable	Placebo	3.8	Standard Deviation 2.6	units on a scale
Sustained Headache Relief	Metoclopramide	24		Participants
Sustained Headache Relief	Placebo	18		Participants
Headache Days	Metoclopramide	3.3	Standard Deviation 1.6	days
Headache Days	Placebo	3.3	Standard Deviation 1.6	days

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Metoclopramide	81
Overall Study	STARTED	Placebo	79
Overall Study	COMPLETED	Metoclopramide	81
Overall Study	COMPLETED	Placebo	79
Overall Study	NOT COMPLETED	Metoclopramide	0
Overall Study	NOT COMPLETED	Placebo	0

Source ClinicalTrials.gov

Adverse events12

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Drowsiness	Nervous system disorders	Metoclopramide	15	81	15
other	Drowsiness	Nervous system disorders	Placebo	8	79	8
other	Akathisia	Nervous system disorders	Metoclopramide	5	81
other	Akathisia	Nervous system disorders	Placebo	0	79
other	Dizziness	Nervous system disorders	Metoclopramide	4	81
other	Dizziness	Nervous system disorders	Placebo	1	79
other	Diarrhea	Gastrointestinal disorders	Metoclopramide	2	81
other	Diarrhea	Gastrointestinal disorders	Placebo	1	79
other	Post-concussive syndrome	Nervous system disorders	Metoclopramide	7	81
other	Post-concussive syndrome	Nervous system disorders	Placebo	5	79

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Metoclopramide	0	81
Total, all-cause mortality	Placebo	0	79
Total, other adverse events	Metoclopramide	35	81
Total, other adverse events	Placebo	22	79
Total, serious adverse events	Metoclopramide	0	81
Total, serious adverse events	Placebo	0	79

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33762421	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Metoclopramide vs Placebo: Sustained Headache Relief	Trial comparisons
Metoclopramide vs Placebo: deaths from any cause	Trial comparisons
Metoclopramide vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03220958

GET https://conductscience.org/api/trials/v1/NCT03220958/registered

API reference For AI assistants