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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02895256
Other study ID # 2016-04-155
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 2016
Est. completion date April 2021

Study information

Verified date March 2020
Source Samsung Medical Center
Contact Mi Ji Lee, MD
Phone 82-2-3410-1895
Email mirony.lee@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date April 2021
Est. primary completion date April 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Any treatment for cluster headache


Locations

Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Changes in the length of active/inactive periods at least 5 years after the first visit
Primary Changes in seasonal and diurnal predilections at least 5 years after the first visit
Primary Changes in autonomic symptoms at least 5 years after the first visit
Primary Changes in treatment responses at least 5 years after the first visit
Secondary Any depression at least 5 years after the first visit
Secondary Any suicidal thoughts (active/passive), plans, and attempts ictal vs interictal at least 5 years after the first vis
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