Migraine Treatment in ED

NCT02643719 | Withdrawn DMC

• 1 other identifier: 14-01981
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

migraine; topiramate

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

Topiramate

ACTIVE COMPARATOR

Drug: Topiramate; Drug: Abortive Medication (Naproxen and Sumatriptan)

Behavioral intervention

ACTIVE COMPARATOR

Behavioral: Relaxation Therapy; Drug: Abortive Medication (Naproxen and Sumatriptan)

topiramate and behavioral intervention

ACTIVE COMPARATOR

Behavioral: Relaxation Therapy; Drug: Topiramate; Drug: Abortive Medication (Naproxen and Sumatriptan)

Standard of Care

ACTIVE COMPARATOR

Drug: Standard of Care; Drug: Abortive Medication (Naproxen and Sumatriptan)

Interventions

Relaxation Therapy 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.

Behavioral intervention; topiramate and behavioral intervention

Topiramate 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)

Topiramate; topiramate and behavioral intervention

Standard of Care 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

Standard of Care

Abortive Medication (Naproxen and Sumatriptan) DRUG

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

Behavioral intervention; Standard of Care; Topiramate; topiramate and behavioral intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

MeSH Terms

Conditions

Migraine Disorders

Interventions

Relaxation Therapy; Topiramate; Standard of Care; Naproxen; Sumatriptan

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Sulfonamides; Amides; Sulfones; Sulfur Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Mia Minen

  New York University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2015
• First Posted: December 31, 2015
• Study Start: December 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: August 24, 2018

Record last verified: 2018-08