Migraine Treatment in ED

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02643719
• Other study ID #: 14-01981
• Status: Withdrawn
• Phase: N/A
• Start date: December 2015
• Est. completion date: October 2017

Study information

• Verified date: August 2018
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

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.

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)
• 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
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Headache Impact Test (HIT) scores		3 Months