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
Last Update Posted : April 30, 2012
Information provided by (Responsible Party):
Benjamin Friedman, 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. We intend to enroll 21 patients in each arm of this study for a total of 42 patients. Using headache surveys, we will determine 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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: An RCT of a Comprehensive Migraine Intervention at the Time of Discharge From the ED 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 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 HIH/ national library of medicine/ X-plain

Behavioral: Reenforcement of diagnosis
Patient told he/s he 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. Headache Impact Test 6 (HIT6) scale [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Satisfaction with care [ Time Frame: 1 month ]
  2. Migraine Disability Assessment Scale (MIDAS) [ Time Frame: 1 month ]
  3. Comfort with disease management [ Time Frame: 1 month ]
  4. Healthcare use [ Time Frame: 1 month ]

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

United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center

Responsible Party: Benjamin Friedman, Associate professor, Montefiore Medical Center Identifier: NCT01071317     History of Changes
Other Study ID Numbers: ED Migraine Intervention
First Posted: February 19, 2010    Key Record Dates
Last Update Posted: April 30, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
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