NCT00313703

Brief Summary

The purpose of this study is to determine how often headaches recur and to learn how to predict continued suffering from headache after emergency department discharge.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
477

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2004

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

March 1, 2004

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 12, 2006

Completed
5.1 years until next milestone

Results Posted

Study results publicly available

May 9, 2011

Completed
Last Updated

May 15, 2018

Status Verified

April 1, 2018

Enrollment Period

1.4 years

First QC Date

April 10, 2006

Results QC Date

October 6, 2010

Last Update Submit

April 16, 2018

Conditions

Headache

Keywords

headacheemergency departmentmigrainerecurrent headache

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Report Moderate or Severe Pain Within 24 Hours of Emergency Department(ED) Discharge

    Moderate/ Severe pain after discharge from the Emergency Department (ED). Moderate and severe are study subject's description of pain

    24 hours after Emergency Department (ED) discharge

Other Outcomes (1)

  • Number of Participants Who Reported Headache Disability Scores (MIDAS) More Than Minimal

    3 months

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Convenience sample of ED patients

You may qualify if:

  • Emergency Department patients who present primarily for headache.
  • Need to consent to and be available for follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center, 111 East 210th Street

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

HeadacheEmergenciesMigraine Disorders

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic ProcessesHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Results Point of Contact

Title
Benjamin Friedman
Organization
Montefiore Medical Center
befriedm@montefiore.org
718-920-6626

Study Officials

  • Benjamin Friedman, MD, MS

    Department of Emergency Medicine, Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Emergency Medicine

Study Record Dates

First Submitted

April 10, 2006

First Posted

April 12, 2006

Study Start

March 1, 2004

Primary Completion

August 1, 2005

Study Completion

November 1, 2005

Last Updated

May 15, 2018

Results First Posted

May 9, 2011

Record last verified: 2018-04

Locations

US(1)