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| Sponsor: | Montefiore Medical Center |
|---|---|
| Information provided by (Responsible Party): | Benjamin Friedman, Montefiore Medical Center |
| ClinicalTrials.gov Identifier: | NCT01071317 |
Purpose
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. We intend to enroll 21 patients in each arm of this study for a total of 42 patients. Using headache surveys, we will determine if the protocol improves migraine-related pain and functional disability one month after the ER visit.
| Condition | Intervention | Phase |
|---|---|---|
|
Migraine |
Drug: Naproxen Drug: Sumatriptan Behavioral: Migraine education Behavioral: Reenforcement of diagnosis Other: Typical care |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | An RCT of a Comprehensive Migraine Intervention at the Time of Discharge From the ED After Treatment for Acute Migraine |
| Enrollment: | 50 |
| Study Start Date: | February 2010 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Comprehensive care
Reinforcement of diagnosis, education, medications, and referral
|
Drug: Naproxen
Naproxen 500mg PO bid prn headache
Drug: Sumatriptan
100mg po q day prn headache
Behavioral: Migraine education
Educational program available through HIH/ national library of medicine/ X-plain
Behavioral: Reenforcement of diagnosis
Patient told he/s he has migraine headache and how the headache meets migraine criteria
|
|
Active Comparator: Typical care
Usual care
|
Other: Typical care
Care to be determined by attending physician
|
Eligibility| Ages Eligible for Study: | 21 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Benjamin Friedman, Associate professor, Montefiore Medical Center |
| ClinicalTrials.gov Identifier: | NCT01071317 History of Changes |
| Other Study ID Numbers: | ED Migraine Intervention |
| Study First Received: | February 17, 2010 |
| Last Updated: | April 26, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
Migraine Disorders Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Naproxen Sumatriptan Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gout Suppressants Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents Vasoconstrictor Agents Cardiovascular Agents Serotonin 5-HT1 Receptor Agonists Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents |
