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

This study is currently recruiting participants.
Verified September 2016 by Chin-Sang Chung, Samsung Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02895256
First Posted: September 9, 2016
Last Update Posted: September 9, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Chin-Sang Chung, Samsung Medical Center
  Purpose
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. We aimed to investigate its disease course, overall prognosis, and treatment pattern in our retrospective cohort.

Condition Intervention
Cluster Headache Prognosis Disease Course Suicide Headache Drug: Any treatment for cluster headache

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by Chin-Sang Chung, Samsung Medical Center:

Primary Outcome Measures:
  • 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

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

Secondary Outcome Measures:
  • Any depression [ Time Frame: 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


Estimated Enrollment: 70
Study Start Date: April 2016
Estimated Primary Completion Date: April 2021 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
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
  Contacts and Locations
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
  More Information

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 Submitted: September 4, 2016
First Posted: September 9, 2016
Last Update Posted: September 9, 2016
Last Verified: September 2016

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