Migraine Treatment in ED

NYU Langone Health

Status: Withdrawn

Conditions: Migraine

Treatments: Drug: Topiramate; Drug: Abortive Medication (Naproxen and Sumatriptan); Behavioral: Relaxation Therapy; Drug: Standard of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT02643719

14-01981

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 4 patient groups

Topiramate

Active Comparator group

Treatment:

Drug: Topiramate

Drug: Abortive Medication (Naproxen and Sumatriptan)

Behavioral intervention

Active Comparator group

Treatment:

Drug: Abortive Medication (Naproxen and Sumatriptan)

Behavioral: Relaxation Therapy

topiramate and behavioral intervention

Active Comparator group

Treatment:

Drug: Topiramate

Drug: Abortive Medication (Naproxen and Sumatriptan)

Behavioral: Relaxation Therapy

Standard of Care

Active Comparator group

Treatment:

Drug: Standard of Care

Drug: Abortive Medication (Naproxen and Sumatriptan)