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Trial record 7 of 449 for:    diphenhydramine

Diphenhydramine for Acute Migraine

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ClinicalTrials.gov Identifier: NCT01825941
Recruitment Status : Completed
First Posted : April 8, 2013
Results First Posted : June 8, 2018
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
Benjamin W. Friedman, MD, Montefiore Medical Center

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.

Condition or disease Intervention/treatment Phase
Migraine Drug: metoclopramide Drug: diphenhydramine Drug: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Diphenhydramine as Adjuvant Therapy for Acute Migraine. A Randomized Trial.
Study Start Date : April 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014


Arm Intervention/treatment
Active Comparator: Metoclopramide + Diphenhydramine
Metoclopramide 10 milligrams + Diphenhydramine 50 milligrams, administered as an intravenous drip over 15 minutes
Drug: metoclopramide
10 milligrams, administered intravenously over 15 minutes
Other Name: Reglan

Drug: diphenhydramine
50 milligrams, administered intravenously over 15 minutes
Other Name: Benadryl

Placebo Comparator: Metoclopramide + placebo
Metoclopramide 10mg + placebo, administered intravenously over 15 minutes
Drug: metoclopramide
10 milligrams, administered intravenously over 15 minutes
Other Name: Reglan

Drug: placebo



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   21 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01825941


Locations
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United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
Investigators
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Principal Investigator: Benjamin W Friedman Montefiore Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Benjamin W. Friedman, MD, Associate professor of Emergency Medicine, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01825941     History of Changes
Other Study ID Numbers: 13-02-071
First Posted: April 8, 2013    Key Record Dates
Results First Posted: June 8, 2018
Last Update Posted: July 31, 2018
Last Verified: July 2018

Keywords provided by Benjamin W. Friedman, MD, Montefiore Medical Center:
migraine
headache
metoclopramide
diphenhydramine

Additional relevant MeSH terms:
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Diphenhydramine
Promethazine
Sleep Aids, Pharmaceutical
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Metoclopramide
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents
Antipruritics
Dermatologic Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists