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Diphenhydramine for Acute Migraine

Information source: Montefiore Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Migraine

Intervention: metoclopramide (Drug); diphenhydramine (Drug); placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Montefiore Medical Center


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 ED 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.

Clinical Details

Official title: Diphenhydramine as Adjuvant Therapy for Acute Migraine. A Randomized Trial.

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Sustained headache relief


Minimum age: 21 Years. Maximum age: 64 Years. Gender(s): Both.


Inclusion Criteria:

- Acute migraine headache

- Present to our emergency room in the Bronx, NY for treatment of migraine headache

Exclusion Criteria:

- Temperature > 100. 3 F

- Pheochromocytoma

- Seizure disorder

- Parkinson's disease

- Use of MAO inhibitors

- Use of anti-rejection transplant medications

- Use of potassium supplements

- Use of pramlintide

Locations and Contacts

Montefiore Medical Center, Bronx, New York 10467, United States
Additional Information

Starting date: April 2013
Last updated: March 19, 2015

Page last updated: August 23, 2015

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