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

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ClinicalTrials.gov Identifier: NCT02895256
Recruitment Status : Recruiting
First Posted : September 9, 2016
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
Chin-Sang Chung, Samsung Medical Center

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.

Condition or disease Intervention/treatment
Cluster Headache Disease Course Drug: Any treatment for cluster headache

Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Retrospective
Study Start Date : April 2016
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache




Primary Outcome Measures :
  1. 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

  2. Changes in the length of active/inactive periods [ Time Frame: at least 5 years after the first visit ]
  3. Changes in seasonal and diurnal predilections [ Time Frame: at least 5 years after the first visit ]
  4. Changes in autonomic symptoms [ Time Frame: at least 5 years after the first visit ]
  5. Changes in treatment responses [ Time Frame: at least 5 years after the first visit ]

Secondary Outcome Measures :
  1. Any depression [ Time Frame: at least 5 years after the first visit ]
  2. Any suicidal thoughts (active/passive), plans, and attempts [ Time Frame: at least 5 years after the first vis ]
    ictal vs interictal



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with cluster headache
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02895256


Contacts
Contact: Mi Ji Lee, MD 82-2-3410-1895 mirony.lee@gmail.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Mi Ji Lee, MD    82-2-3410-1895    mirony.lee@samsung.com   
Sponsors and Collaborators
Samsung Medical Center

Responsible Party: Chin-Sang Chung, MD, PhD, Professor of neurology, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02895256     History of Changes
Other Study ID Numbers: 2016-04-155
First Posted: September 9, 2016    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Headache
Cluster Headache
Disease Progression
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Disease Attributes
Pathologic Processes