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Diphenhydramine for Acute Migraine

NCT01825941 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2018-07-31

Study results available
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Summary

Parenteral diphenhydramine is commonly used as adjuvant therapy for acute migraine despite the fact that data supporting this practice do not exist. The investigators propose a randomized double blind study to test the hypothesis that 50mg of intravenous diphenhydramine, when added to standard migraine therapy, will result in a greater rate of sustained headache relief than standard migraine therapy alone. For this study, standard migraine therapy will be 10mg of intravenous metoclopramide. 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. Patients who present to the Montefiore emergency room (Bronx, NY) with an acute migraine will be approached for participation. They will be screened for medication contra-indications and non-migraine etiologies of headache. The study will be randomized. Assignment will be concealed. Participants and researchers will be blinded. Efficacy outcomes and adverse events will be assessed every half hour for two hours in the Emergency Department and by telephone 48 hours after medication administration. A sample size calculation, based on pilot data, revealed the need for 374 participants. An interim analysis will be performed after 200 participants have been enrolled with the goal of assessing for lack of conditional power.

Conditions

Interventions

DRUG

metoclopramide

10 milligrams, administered intravenously over 15 minutes

DRUG

diphenhydramine

50 milligrams, administered intravenously over 15 minutes

DRUG

placebo

Sponsors & Collaborators

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Benjamin W Friedman · Montefiore Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01825941 on ClinicalTrials.gov