Migraine Treatment in ED

Study Overview
=================
Brief Summary
-----------------
Randomized pilot feasibility study evaluating the impact of introducing behavioral treatment for migraine in the Emergency Department (ED) and prescribing migraine preventive medications in the ED. The study will examine the effect of these treatments, both individually and in combination, on pain severity and headache-related disability. This study is designed to examine the feasibility of comparing four interventions for ED patients presenting with migraine. Group 1: Starting topiramate; Group 2: Doing a brief behavioral intervention; Group 3: Treating with combination therapy of topiramate and behavioral intervention; and Group 4: Standard of Care.

Official Title
-----------------
Evaluation of a Behavioral Program for Migraineurs in the Emergency Department.

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Behavioral: Relaxation Therapy
* Drug: Topiramate
* Drug: Standard of Care
* Drug: Abortive Medication (Naproxen and Sumatriptan)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 years to 65 years of age primary diagnosis of migraine based on the International Classification of headache disorders 3 beta criteria having a migraine 3 or more days/month. Exclusion Criteria: Cognitive Behavioral Therapy (CBT), biofeedback or other relaxation therapy in the past year being on medication used for migraine prevention (topiramate, propranolol, valproic acid, amitriptyline/nortriptyline/imipramine/desipramine, botulinum toxin, a SNRI, angiotensin-converting enzyme inhibitors (ACE-I) or ARB) cognitive deficit or other physical problem with the potential to interfere with behavioral therapy substance or alcohol abuse as determined by self-report or prior documentation in the medical record.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Topiramate<br> | Drug: Topiramate<br>* Preventive medication prescriptions given to the patient along with written instructions and information about side effects: Topiramate 25mg tabs (with a plan to increase to 100mg)<br>Drug: Abortive Medication (Naproxen and Sumatriptan)<br>* All participants will receive abortive medication for acute treatment of their migraine. Preferred medications are Naproxen (500mg) and Sumatriptan (100mg)<br>|
| Active Comparator: Behavioral intervention<br> | Behavioral: Relaxation Therapy<br>* Between 30-60 minutes after the standard of care medication administration (metoclopramide, magnesium, prochlorperazine, ketorolac, or steroids at discretion of treating physician), patient receives training in relaxation therapy.<br>Drug: Abortive Medication (Naproxen and Sumatriptan)<br>* All participants will receive abortive medication for acute treatment of their migraine. Preferred medications are Naproxen (500mg) and Sumatriptan (100mg)<br>|
| Active Comparator: topiramate and behavioral intervention<br> | Behavioral: Relaxation Therapy<br>* Between 30-60 minutes after the standard of care medication administration (metoclopramide, magnesium, prochlorperazine, ketorolac, or steroids at discretion of treating physician), patient receives training in relaxation therapy.<br>Drug: Topiramate<br>* Preventive medication prescriptions given to the patient along with written instructions and information about side effects: Topiramate 25mg tabs (with a plan to increase to 100mg)<br>Drug: Abortive Medication (Naproxen and Sumatriptan)<br>* All participants will receive abortive medication for acute treatment of their migraine. Preferred medications are Naproxen (500mg) and Sumatriptan (100mg)<br>|
| Active Comparator: Standard of Care<br> | Drug: Standard of Care<br>* Standard discharge instruction sheet plus standard of care medication as prescribed by treating physician. The clinical team will be instructed to address post-discharge care as appropriate<br>Drug: Abortive Medication (Naproxen and Sumatriptan)<br>* All participants will receive abortive medication for acute treatment of their migraine. Preferred medications are Naproxen (500mg) and Sumatriptan (100mg)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verbal numeric rating scale (VNRS) scores | To examine whether there is a significant pain reduction for patients in the ED after behavioral therapy, investigators will analyze pain scores in the ED, and at 24 hours and 72 hours. | 24 hours, 72 hours | 
| Headache Impact Test (HIT) scores |  | 3 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
migraine, topiramate