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NCT01825941 · ClinicalTrials.gov registry record · Phase 4
Diphenhydramine for Acute Migraine
A Phase 4 study, sponsored by Montefiore Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 208
- Enrollment target
NCT01825941 is a Phase 4 study that has completed, run by Montefiore Medical Center. The registered enrollment target is 208 participants.
The verdict
NCT01825941, a Phase 4 study, has completed, sponsored by Montefiore Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 208 participants
- Enrollment target
Study 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.
Interventions
- DRUG placebo
- DRUG diphenhydramine
- DRUG metoclopramide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 208 participants |
| Start Date | 2013-04 |
| Est. Completion | 2014-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01825941
The ClinicalTrials.gov registry entry for NCT01825941 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 208 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Montefiore Medical Center, which has 345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT01825941 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01825941 about?
NCT01825941 is a clinical study titled "Diphenhydramine for Acute Migraine". 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 migra...
What is the current status of trial NCT01825941?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 208 participants. The study started on 2013-04. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01825941?
The interventions under investigation include: placebo (DRUG), diphenhydramine (DRUG), metoclopramide (DRUG).
Who is sponsoring clinical trial NCT01825941?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
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