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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01825941
Other study ID # 13-02-071
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date April 2013
Est. completion date December 2014

Study information

Verified date July 2018
Source Montefiore Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 208
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender All
Age group 21 Years to 64 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
metoclopramide
10 milligrams, administered intravenously over 15 minutes
diphenhydramine
50 milligrams, administered intravenously over 15 minutes
placebo


Locations

Country Name City State
United States Montefiore Medical Center Bronx New York

Sponsors (1)

Lead Sponsor Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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