Diphenhydramine for Acute Migraine

NCT01825941 | Completed Phase 4 Results DMC

• 1 other identifier: 13-02-071
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief 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

Migraine

Keywords

migraine; headache; metoclopramide; diphenhydramine

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Sustained Headache Relief Assessed by Self-evaluation

  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

  up to 2 hours in Emergency Department, 48 hours after discharge from Emergency Department

Study Arms (2)

Metoclopramide + Diphenhydramine

ACTIVE COMPARATOR

Metoclopramide 10 milligrams + Diphenhydramine 50 milligrams, administered as an intravenous drip over 15 minutes

Drug: metoclopramide; Drug: diphenhydramine

Metoclopramide + placebo

PLACEBO COMPARATOR

Metoclopramide 10mg + placebo, administered intravenously over 15 minutes

Drug: metoclopramide; Drug: placebo

Interventions

metoclopramide DRUG

10 milligrams, administered intravenously over 15 minutes

Also known as: Reglan

Metoclopramide + Diphenhydramine; Metoclopramide + placebo

diphenhydramine DRUG

50 milligrams, administered intravenously over 15 minutes

Also known as: Benadryl

Metoclopramide + Diphenhydramine

placebo DRUG

Metoclopramide + placebo

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Temperature \> 100.3 F
• Pheochromocytoma
• Seizure disorder
• Parkinson's disease
• Use of monoamine oxidase (MAO) inhibitors
• Use of anti-rejection transplant medications
• Use of potassium supplements
• Use of pramlintide

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (1)

• Friedman BW, Cabral L, Adewunmi V, Solorzano C, Esses D, Bijur PE, Gallagher EJ. Diphenhydramine as Adjuvant Therapy for Acute Migraine: An Emergency Department-Based Randomized Clinical Trial. Ann Emerg Med. 2016 Jan;67(1):32-39.e3. doi: 10.1016/j.annemergmed.2015.07.495. Epub 2015 Aug 29.

  PMID: 26320523 DERIVED

MeSH Terms

Conditions

Migraine Disorders; Headache

Interventions

Metoclopramide; Diphenhydramine

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols; Ethylamines; Amines; Benzhydryl Compounds

Results Point of Contact

• Title: Benjamin W. Friedman, MD, MS
• Organization: Montefiore Medical Center

befriedm@montefiore.org

718-920-6266

Study Officials

• Benjamin W Friedman

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of Emergency Medicine

Study Record Dates

• First Submitted: April 2, 2013
• First Posted: April 8, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 31, 2018
• Results First Posted: June 8, 2018

Record last verified: 2018-07

Locations

US (1)