drugset / Trial / NCT02945839

Improving Health Outcomes of Migraine Patients Who Present to the Emergency Department

NCT02945839

Phase 4 Withdrawn NYU Langone Health
RandomizedParallel-groupDouble-blindTreatment

Summary

Collectively, evidence shows that a combination of medication and behavioral therapy is most effective for migraine care. The ED is a critical point of contact with the health care system for many migraine patients; in current practice, it is a missed opportunity to initiate and establish a comprehensive migraine management paradigm. Behavioral headache treatments (e.g., progressive muscle relaxation (PMR), biofeedback, cognitive-behavioral therapy (CBT)) are effective migraine treatment options that are essentially free of side effects. PMR has also been successful as a technique that patients can do independently. Studies have shown that combination pharmacological-behavioral therapy is most effective for migraine treatment. Several aspects of this study are innovative, including: 1. Initiation of preventive medication in a timely manner for migraineurs who present to the ED. 2. Introduction of PM+PMR in the ED at a time that can serve as a teachable moment. 3. Introduction of a smartphone application-based product (a minimal contact based behavioral therapy) in the ED setting to reduce headache disability, frequency, and intensity.

Timeline

Start
2016-12-28
Primary completion
2019-12
Completion
2019-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Topiramate Small molecule 100 mg

Indications