Long-term Prognosis of Cluster Headache: a Retrospective Cohort Study

March 18, 2020 updated by: Chin-Sang Chung, Samsung Medical Center
Cluster headache is a syndrome characterized by disabling headache and accompanying autonomic symptoms. Despite cluster headache is called "suicide headache", its natural history has not been well investigated. The investigators aimed to investigate its disease course, overall prognosis, and treatment pattern in retrospective cohort.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with cluster headache

Description

Inclusion Criteria:

  • Patients who were diagnosed as cluster headache
  • More than 5 years after the first visit

Exclusion Criteria:

  • Subjects who refused the telephone visit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall prognosis
Time Frame: at least 5 years after the first visit
active disease: at least one bout within the past 5 years Remission: no headache for 5 years and twice of the usual remission period
at least 5 years after the first visit
Changes in the length of active/inactive periods
Time Frame: at least 5 years after the first visit
at least 5 years after the first visit
Changes in seasonal and diurnal predilections
Time Frame: at least 5 years after the first visit
at least 5 years after the first visit
Changes in autonomic symptoms
Time Frame: at least 5 years after the first visit
at least 5 years after the first visit
Changes in treatment responses
Time Frame: at least 5 years after the first visit
at least 5 years after the first visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Any depression
Time Frame: at least 5 years after the first visit
at least 5 years after the first visit
Any suicidal thoughts (active/passive), plans, and attempts
Time Frame: at least 5 years after the first vis
ictal vs interictal
at least 5 years after the first vis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

April 1, 2021

Study Completion (Anticipated)

April 1, 2021

Study Registration Dates

First Submitted

September 4, 2016

First Submitted That Met QC Criteria

September 4, 2016

First Posted (Estimate)

September 9, 2016

Study Record Updates

Last Update Posted (Actual)

March 20, 2020

Last Update Submitted That Met QC Criteria

March 18, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-04-155

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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