NCT00880425

Brief Summary

The objective of this study is to determine if patients with chronic daily headache have continuous headache or moments of headache relief. The secondary objective of this study is to determine the period of time patients who have chronic daily headache that is not continuous are headache free.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2009

Shorter than P25 for all trials

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

April 1, 2009

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 13, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

October 29, 2010

Completed
Last Updated

February 28, 2025

Status Verified

February 1, 2025

Enrollment Period

2 months

First QC Date

April 10, 2009

Results QC Date

October 22, 2010

Last Update Submit

February 9, 2025

Conditions

Chronic Daily Headache

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects With Daily Headache Who Have Continuous Headache

    Records were reviewed from April 2009 through June 2009

Secondary Outcomes (1)

  • Number of Patient With Daily Headache Who Have Non-continuous Headache

    Records were reviewed from April 2009 through June 2009

Study Arms (2)

Participants with continuous headache

Participants with non-continuous headache

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Headache clinic patients with diagnosis of Chronic Migraine, New Daily Persistent Headache, Chronic Tension type headache, or chronic post traumatic headache, over age 18.

You may qualify if:

  • Patients with Chronic Migraine, New Daily Persistent Headache, Chronic Tension type headache, or chronic post traumatic headache seen at the Jefferson Headache Center.

You may not qualify if:

  • Subjects under age 18.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jessica Ailani

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Headache Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Results Point of Contact

Title
Jessica Ailani, MD/ Headache Fellow
Organization
Thomas Jefferson University
Jessica.Ailani@gmail.com
631-807-8194

Study Officials

  • Stephen D Silberstein, MD

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurology

Study Record Dates

First Submitted

April 10, 2009

First Posted

April 13, 2009

Study Start

April 1, 2009

Primary Completion

June 1, 2009

Study Completion

July 1, 2009

Last Updated

February 28, 2025

Results First Posted

October 29, 2010

Record last verified: 2025-02

Locations

US(1)