Trial · NCT01825941

Diphenhydramine for Acute Migraine

NCT01825941, Phase 4, Completed, Montefiore Medical Center; results first posted 2018-06-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Diphenhydramine for Acute Migraine. Trials, record NCT01825941. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01825941

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Trial

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

Title: Diphenhydramine for Acute Migraine
NCT number: NCT01825941
Status: Completed
Phases: Phase 4
Enrollment: 208 participants, actual
Lead sponsor: Montefiore Medical Center
Conditions: Migraine
Interventions: metoclopramide, diphenhydramine, placebo
First posted: 2013-04-08
Last updated: 2018-07-31
Results first posted: 2018-06-08

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Number of Participants With Sustained Headache Relief Assessed by Self-evaluation	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

Source ClinicalTrials.gov

Outcomes1

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Sustained Headache Relief Assessed by Self-evaluation	up to 2 hours in Emergency Department, 48 hours after discharge from Emergency Department		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group2

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

Outcome	Group	Category	Value	Spread	Units
Number of Participants With Sustained Headache Relief Assessed by Self-evaluation	Metoclopramide + Diphenhydramine		40		Participants
Number of Participants With Sustained Headache Relief Assessed by Self-evaluation	Metoclopramide + Placebo		38		Participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Metoclopramide + Diphenhydramine	104
Overall Study	STARTED	Metoclopramide + Placebo	104
Overall Study	COMPLETED	Metoclopramide + Diphenhydramine	100
Overall Study	COMPLETED	Metoclopramide + Placebo	103
Overall Study	NOT COMPLETED	Metoclopramide + Diphenhydramine	4
Overall Study	NOT COMPLETED	Metoclopramide + Placebo	1

Source ClinicalTrials.gov

Adverse events4

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	Restlessness	Nervous system disorders	Metoclopramide + Diphenhydramine	8	104	8
other	Restlessness	Nervous system disorders	Metoclopramide + Placebo	7	104	7
other	Drowsy	Nervous system disorders	Metoclopramide + Diphenhydramine	17	104	17
other	Drowsy	Nervous system disorders	Metoclopramide + Placebo	14	104	14

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Metoclopramide + Diphenhydramine	0	104
Total, all-cause mortality	Metoclopramide + Placebo	0	104
Total, other adverse events	Metoclopramide + Diphenhydramine	25	104
Total, other adverse events	Metoclopramide + Placebo	21	104
Total, serious adverse events	Metoclopramide + Diphenhydramine	0	104
Total, serious adverse events	Metoclopramide + Placebo	0	103

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
26320523	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 + Diphenhydramine vs Metoclopramide + Placebo: Number of Participants With Sustained Headache Relief Assessed by Self-evaluation	Trial comparisons
Metoclopramide + Diphenhydramine vs Metoclopramide + Placebo: deaths from any cause	Trial comparisons
Metoclopramide + Diphenhydramine vs Metoclopramide + 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/NCT01825941

GET https://conductscience.org/api/trials/v1/NCT01825941/registered

API reference For AI assistants