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Trial of Comprehensive Migraine Intervention

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. Identifier: NCT01071317
Recruitment Status : Completed
First Posted : February 19, 2010
Results First Posted : July 26, 2018
Last Update Posted : August 31, 2018
Information provided by (Responsible Party):
Benjamin W. Friedman, MD, Montefiore Medical Center

Brief Summary:
Despite the fact that more than 10% of Americans suffer from migraine, this headache disorder is often not diagnosed and not appropriately treated. The goal of this proposal is to determine whether a migraine protocol designed for use in an emergency room can be used to deliver the headache care that many migraine patients never receive. This is a randomized trial. Consecutive inadequately treated migraine patients will be randomized to TYPICAL care or to COMPREHENSIVE care. Those patients in the comprehensive care arm will receive the following intervention: 1) reinforcement of diagnosis, 2) an adaptable online educational intervention, reading material, and headache diaries, 3) two migraine specific medications and 4) expedited referral to a headache specialist, if needed. Patients in the typical care arm will receive whatever intervention the emergency physician feels is most appropriate. Headache surveys will be used toll if the protocol improves migraine-related pain and functional disability one month after the ER visit.

Condition or disease Intervention/treatment Phase
Migraine Drug: Naproxen Drug: Sumatriptan Behavioral: Migraine education Behavioral: Reenforcement of diagnosis Other: Typical care Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Random Controlled Trial a Comprehensive Migraine Intervention at the Time of Discharge From the Emergency Department After Treatment for Acute Migraine
Study Start Date : February 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Experimental: Comprehensive care
Reinforcement of diagnosis, education, medications, and referral
Drug: Naproxen
Naproxen 500mg PO bid prn headache

Drug: Sumatriptan
100mg po q day prn headache

Behavioral: Migraine education
Educational program available through NIH/ national library of medicine/ X-plain

Behavioral: Reenforcement of diagnosis
Patient advised has migraine headache and how the headache meets migraine criteria

Active Comparator: Typical care
Usual care
Other: Typical care
Care to be determined by attending physician

Primary Outcome Measures :
  1. Migraine Functional Impairment as Measured by Score on the Headache Impact Test 6 (HIT6) Scale [ Time Frame: 1 month after study enrollment ]
    This is a standardized instrument commonly used in migraine research. Participants answer 6 Likert questions about the impact of migraine on their daily life. A score of 36, the lowest possible score, indicates minimal functional impairment. A score of 78, the highest possible score, indicates substantial functional impairment

Secondary Outcome Measures :
  1. Number of Participants Who Report Satisfaction With Treatment, as Measured by a Three Item Likert Scale [ Time Frame: 1 month after study enrollment ]
    Participants could report that they were completely satisfied, mostly satisfied or unsatisfied. Reported here are the number who were unsatisfied.

  2. Number of Participants Who Report They Are Comfortable With Disease Management, as Measured by a Three-item Likert Scale [ Time Frame: 1 month after study enrollment ]
    Participants were asked to describe themselves as very comfortable, somewhat comfortable, or uncomfortable. Reported here are those who were very comfortable

  3. Number of Participants Who Returned to the Emergency Department for Management of Headache [ Time Frame: 1 month after study enrollment ]
    We report the number of patient who returned to the emergency department for management of headache

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Migraine,
  • Baseline migraine related disability of mild or worse,
  • No current or past triptan use,
  • Not satisfied with current headache care.

Exclusion Criteria:

  • Allergy or contraindication to study medications,
  • Daily or near daily analgesic medication use.

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 identifier (NCT number): NCT01071317

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United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
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Responsible Party: Benjamin W. Friedman, MD, Associate professor, Montefiore Medical Center Identifier: NCT01071317    
Other Study ID Numbers: 09-08-248
First Posted: February 19, 2010    Key Record Dates
Results First Posted: July 26, 2018
Last Update Posted: August 31, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents