NCT01071317

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 19, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
6.6 years until next milestone

Results Posted

Study results publicly available

July 26, 2018

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

1.9 years

First QC Date

February 17, 2010

Results QC Date

April 15, 2018

Last Update Submit

August 1, 2018

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

  • Migraine Functional Impairment as Measured by Score on the Headache Impact Test 6 (HIT6) Scale

    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

    1 month after study enrollment

Secondary Outcomes (3)

  • Number of Participants Who Report Satisfaction With Treatment, as Measured by a Three Item Likert Scale

    1 month after study enrollment

  • Number of Participants Who Report They Are Comfortable With Disease Management, as Measured by a Three-item Likert Scale

    1 month after study enrollment

  • Number of Participants Who Returned to the Emergency Department for Management of Headache

    1 month after study enrollment

Study Arms (2)

Comprehensive care

EXPERIMENTAL

Reinforcement of diagnosis, education, medications, and referral

Drug: NaproxenDrug: SumatriptanBehavioral: Migraine educationBehavioral: Reenforcement of diagnosis

Typical care

ACTIVE COMPARATOR

Usual care

Other: Typical care

Interventions

NaproxenDRUG

Naproxen 500mg PO bid prn headache

Comprehensive care
SumatriptanDRUG

100mg po q day prn headache

Comprehensive care
Migraine educationBEHAVIORAL

Educational program available through NIH/ national library of medicine/ X-plain

Comprehensive care
Reenforcement of diagnosisBEHAVIORAL

Patient advised has migraine headache and how the headache meets migraine criteria

Comprehensive care
Typical careOTHER

Care to be determined by attending physician

Typical care

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

NaproxenSumatriptan

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Naphthaleneacetic AcidsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsSulfonamidesAmidesSulfonesSulfur CompoundsTryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Benjamin W. Friedman, MD
Organization
Montefiore Health
befriedm@montefiore.org
718-920-6626

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

February 17, 2010

First Posted

February 19, 2010

Study Start

February 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

August 31, 2018

Results First Posted

July 26, 2018

Record last verified: 2018-08

Locations

US(1)