- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01825941
Diphenhydramine for Acute Migraine
July 2, 2018 updated by: Benjamin W. Friedman, MD, Montefiore Medical Center
Diphenhydramine as Adjuvant Therapy for Acute Migraine. A Randomized Trial.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
208
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Bronx, New York, United States, 10467
- Montefiore Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 monoamine oxidase (MAO) inhibitors
- Use of anti-rejection transplant medications
- Use of potassium supplements
- Use of pramlintide
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Metoclopramide + Diphenhydramine
Metoclopramide 10 milligrams + Diphenhydramine 50 milligrams, administered as an intravenous drip over 15 minutes
|
10 milligrams, administered intravenously over 15 minutes
Other Names:
50 milligrams, administered intravenously over 15 minutes
Other Names:
|
Placebo Comparator: Metoclopramide + placebo
Metoclopramide 10mg + placebo, administered intravenously over 15 minutes
|
10 milligrams, administered intravenously over 15 minutes
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Sustained Headache Relief Assessed by Self-evaluation
Time Frame: 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
|
up to 2 hours in Emergency Department, 48 hours after discharge from Emergency Department
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Benjamin W Friedman, Montefiore Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
April 2, 2013
First Submitted That Met QC Criteria
April 5, 2013
First Posted (Estimate)
April 8, 2013
Study Record Updates
Last Update Posted (Actual)
July 31, 2018
Last Update Submitted That Met QC Criteria
July 2, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Headache Disorders, Primary
- Headache Disorders
- Migraine Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Antiemetics
- Gastrointestinal Agents
- Dermatologic Agents
- Dopamine Agents
- Dopamine D2 Receptor Antagonists
- Dopamine Antagonists
- Hypnotics and Sedatives
- Anesthetics, Local
- Anti-Allergic Agents
- Sleep Aids, Pharmaceutical
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Antipruritics
- Diphenhydramine
- Promethazine
- Metoclopramide
Other Study ID Numbers
- 13-02-071
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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