Migraine
Conditions
Keywords
migraine, topiramate
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.
Interventions
BEHAVIORALRelaxation Therapy
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.
DRUGTopiramate
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)
DRUGStandard of Care
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
DRUGAbortive Medication (Naproxen and Sumatriptan)
All participants will receive abortive medication for acute treatment of their migraine. Preferred medications are Naproxen (500mg) and Sumatriptan (100mg)
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Verbal numeric rating scale (VNRS) scores | 24 hours, 72 hours | 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. |
| Headache Impact Test (HIT) scores | 3 Months | — |
Outcome results
None listed