CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 50 enrolled
Drug / intervention
Naproxen +4 moredrug
Likely dose
Naproxen 500mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01071317
NCT01071317Phase 4Completed

A Random Controlled Trial a Comprehensive Migraine Intervention at the Time of Discharge From the Emergency Department After Treatment for Acute Migraine

Montefiore Medical Center·interventional·Posted Feb 19, 2010·Updated Aug 31, 2018

In Brief

A Phase 4 clinical trial evaluating Naproxen, Sumatriptan, and 3 other interventions for Migraine. Completed, enrolled 50 participants across 1 site.

Detailed Summary

Despite the fact that more than 10% of Americans suffer from migraine, this headache disorder is often not diagnosed and not appropriately treated. The goal of this proposal is to determine whether a migraine protocol designed for use in an emergency room can be used to deliver the headache care that many migraine patients never receive. This is a randomized trial. Consecutive inadequately treated migraine patients will be randomized to TYPICAL care or to COMPREHENSIVE care. Those patients in the comprehensive care arm will receive the following intervention: 1) reinforcement of diagnosis, 2) an adaptable online educational intervention, reading material, and headache diaries, 3) two migraine specific medications and 4) expedited referral to a headache specialist, if needed. Patients in the typical care arm will receive whatever intervention the emergency physician feels is most appropriate. Headache surveys will be used toll if the protocol improves migraine-related pain and functional disability one month after the ER visit.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 19, 2010
Enrollment StartFeb 1, 2010
Primary CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 16.4 years ago

Interventions

Naproxendrug

Naproxen 500mg PO bid prn headache

Sumatriptandrug

100mg po q day prn headache

Migraine educationbehavioral

Educational program available through NIH/ national library of medicine/ X-plain

Reenforcement of diagnosisbehavioral

Patient advised has migraine headache and how the headache meets migraine criteria

Typical careother

Care to be determined by attending physician