Back to resultsMigraine Treatment in ED
Primary Purpose
Migraine
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Relaxation Therapy
Topiramate
Standard of Care
Abortive Medication (Naproxen and Sumatriptan)
Sponsored by
About this trial
This is an interventional treatment trial for Migraine focused on measuring migraine, topiramate
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Topiramate
Behavioral intervention
topiramate and behavioral intervention
Standard of Care
Arm Description
Outcomes
Primary Outcome Measures
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.
Headache Impact Test (HIT) scores
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02643719
Brief Title
Migraine Treatment in ED
Official Title
Evaluation of a Behavioral Program for Migraineurs in the Emergency Department.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Study team missed continuing review and study lapsed with out recruiting any subjects.
Study Start Date
December 2015 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
migraine, topiramate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Topiramate
Arm Type
Active Comparator
Arm Title
Behavioral intervention
Arm Type
Active Comparator
Arm Title
topiramate and behavioral intervention
Arm Type
Active Comparator
Arm Title
Standard of Care
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Relaxation Therapy
Intervention Description
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
Drug
Intervention Name(s)
Topiramate
Intervention Description
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
Intervention Name(s)
Standard of Care
Intervention Description
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
Intervention Name(s)
Abortive Medication (Naproxen and Sumatriptan)
Intervention Description
All participants will receive abortive medication for acute treatment of their migraine. Preferred medications are Naproxen (500mg) and Sumatriptan (100mg)
Primary Outcome Measure Information:
Title
Verbal numeric rating scale (VNRS) scores
Description
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.
Time Frame
24 hours, 72 hours
Title
Headache Impact Test (HIT) scores
Time Frame
3 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mia Minen
Organizational Affiliation
New York University Medical School
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Migraine Treatment in ED
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