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Migraine Treatment in ED

This study is currently recruiting participants.
Verified December 2017 by New York University School of Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT02643719
First Posted: December 31, 2015
Last Update Posted: December 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
New York University School of Medicine
  Purpose
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.

Condition Intervention
Migraine Behavioral: Relaxation Therapy Drug: Topiramate Drug: Standard of Care Drug: Abortive Medication (Naproxen and Sumatriptan)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of a Behavioral Program for Migraineurs in the Emergency Department.

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Verbal numeric rating scale (VNRS) scores [ Time Frame: 24 hours, 72 hours ]
    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.

  • Headache Impact Test (HIT) scores [ Time Frame: 3 Months ]

Estimated Enrollment: 100
Study Start Date: December 2015
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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: 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: topiramate and behavioral 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)

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: Standard of Care 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
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)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02643719


Contacts
Contact: Ada Rubin rubina07@nyumc.org
Contact: Liliana Serrano Liliana.Serrano2@nyumc.org

Locations
United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Mia T Minen, MD, MPH       Mia.Minen@nyumc.org   
Principal Investigator: Mia Ninen, M.D.         
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Mia Minen New York University Medical School
  More Information

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02643719     History of Changes
Other Study ID Numbers: 14-01981
First Submitted: December 29, 2015
First Posted: December 31, 2015
Last Update Posted: December 6, 2017
Last Verified: December 2017

Keywords provided by New York University School of Medicine:
migraine
topiramate

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Naproxen
Topiramate
Sumatriptan
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
Neuroprotective Agents
Protective Agents
Anti-Obesity Agents
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents