Migraine Treatment in ED

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Migraine
• Intervention / Treatment: Drug: Topiramate; Drug: Abortive Medication (Naproxen and Sumatriptan); Behavioral: Relaxation Therapy; Drug: Standard of Care

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care	Drug: Abortive Medication (Naproxen and Sumatriptan); All participants will receive abortive medication for acute treatment of their migraine. Preferred medications are Naproxen (500mg) and Sumatriptan (100mg); Drug: Standard 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
Active Comparator: Topiramate	Drug: Topiramate; 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); Drug: Abortive Medication (Naproxen and Sumatriptan); All participants will receive abortive medication for acute treatment of their migraine. Preferred medications are Naproxen (500mg) and Sumatriptan (100mg)
Active Comparator: Behavioral intervention	Drug: Abortive Medication (Naproxen and Sumatriptan); All participants will receive abortive medication for acute treatment of their migraine. Preferred medications are Naproxen (500mg) and Sumatriptan (100mg); Behavioral: Relaxation 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.
Active Comparator: topiramate and behavioral intervention	Drug: Topiramate; 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); Drug: Abortive Medication (Naproxen and Sumatriptan); All participants will receive abortive medication for acute treatment of their migraine. Preferred medications are Naproxen (500mg) and Sumatriptan (100mg); Behavioral: Relaxation 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.

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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Mia Minen, New York University Medical School

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: December 29, 2015
• First Submitted That Met QC Criteria: December 30, 2015
• First Posted (Estimate): December 31, 2015

Study Record Updates

• Last Update Posted (Actual): August 24, 2018
• Last Update Submitted That Met QC Criteria: August 22, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: migraine; topiramate
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Hypoglycemic Agents; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Serotonin Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Anticonvulsants; Gout Suppressants; Vasoconstrictor Agents; Naproxen; Topiramate; Sumatriptan
• Other Study ID Numbers: 14-01981