NCT02895256

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

March 20, 2020

Status Verified

March 1, 2020

Enrollment Period

5 years

First QC Date

September 4, 2016

Last Update Submit

March 18, 2020

Conditions

Cluster HeadacheDisease Course

Outcome Measures

Primary Outcomes (5)

  • overall prognosis

    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

    at least 5 years after the first visit

  • Changes in seasonal and diurnal predilections

    at least 5 years after the first visit

  • Changes in autonomic symptoms

    at least 5 years after the first visit

  • Changes in treatment responses

    at least 5 years after the first visit

Secondary Outcomes (2)

  • Any depression

    at least 5 years after the first visit

  • Any suicidal thoughts (active/passive), plans, and attempts

    at least 5 years after the first vis

Interventions

Any treatment for cluster headacheDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with cluster headache

You may qualify if:

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

You may not qualify if:

  • Subjects who refused the telephone visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Cluster HeadacheDisease Progression

Condition Hierarchy (Ancestors)

Trigeminal Autonomic CephalalgiasHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Mi Ji Lee, MD

CONTACT

82-2-3410-1895mirony.lee@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Professor of neurology

Study Record Dates

First Submitted

September 4, 2016

First Posted

September 9, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

March 20, 2020

Record last verified: 2020-03

Locations

KR(1)