Migraine Treatment in ED

NCT ID: NCT02643719

Last Updated: 2018-08-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2017-10-31

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.

Conditions

Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Topiramate

Group Type: ACTIVE_COMPARATOR

Topiramate

Intervention Type: DRUG

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)

Abortive Medication (Naproxen and Sumatriptan)

Intervention Type: DRUG

All participants will receive abortive medication for acute treatment of their migraine. Preferred medications are Naproxen (500mg) and Sumatriptan (100mg)

Behavioral intervention

Group Type: ACTIVE_COMPARATOR

Relaxation Therapy

Intervention Type: BEHAVIORAL

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.

Abortive Medication (Naproxen and Sumatriptan)

Intervention Type: DRUG

All participants will receive abortive medication for acute treatment of their migraine. Preferred medications are Naproxen (500mg) and Sumatriptan (100mg)

topiramate and behavioral intervention

Group Type: ACTIVE_COMPARATOR

Relaxation Therapy

Intervention Type: BEHAVIORAL

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.

Topiramate

Intervention Type: DRUG

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)

Abortive Medication (Naproxen and Sumatriptan)

Intervention Type: DRUG

All participants will receive abortive medication for acute treatment of their migraine. Preferred medications are Naproxen (500mg) and Sumatriptan (100mg)

Standard of Care

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: DRUG

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)

Intervention Type: DRUG

All participants will receive abortive medication for acute treatment of their migraine. Preferred medications are Naproxen (500mg) and Sumatriptan (100mg)

Interventions

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.

Intervention Type: BEHAVIORAL

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)

Intervention Type: 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

Intervention Type: 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)

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mia Minen

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Other Identifiers

14-01981

Identifier Type: -

Identifier Source: org_study_id