Migraine Treatment in ED

Not Applicable

Withdrawn

• Conditions: Migraine
• Interventions: Drug: Topiramate; Behavioral: Relaxation Therapy; Drug: Standard of Care; Drug: Abortive Medication (Naproxen and Sumatriptan)

• Registration Number: NCT02643719
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-29
• Study First Submitted QC: 2015-12-30
• Study First Posted: 2015-12-31
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-22
• Last Update Posted: 2018-08-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topiramate	Topiramate	-
Topiramate	Abortive Medication (Naproxen and Sumatriptan)	-
Behavioral intervention	Relaxation Therapy	-
Behavioral intervention	Abortive Medication (Naproxen and Sumatriptan)	-
topiramate and behavioral intervention	Relaxation Therapy	-
topiramate and behavioral intervention	Topiramate	-
topiramate and behavioral intervention	Abortive Medication (Naproxen and Sumatriptan)	-
Standard of Care	Standard of Care	-
Standard of Care	Abortive Medication (Naproxen and Sumatriptan)	-

Primary Outcome Measures

Name	Time	Method
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