ClinicalTrials.gov
ClinicalTrials.gov Menu

Migraine Treatment in ED

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02643719
Recruitment Status : Withdrawn (Study team missed continuing review and study lapsed with out recruiting any subjects.)
First Posted : December 31, 2015
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Migraine Behavioral: Relaxation Therapy Drug: Topiramate Drug: Standard of Care Drug: Abortive Medication (Naproxen and Sumatriptan) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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.
Actual Study Start Date : December 2015
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
Drug Information available for: Topiramate

Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. 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.

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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.

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


Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Mia Minen New York University Medical School

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02643719     History of Changes
Other Study ID Numbers: 14-01981
First Posted: December 31, 2015    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018

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