Cluster HeadacheNCT02895256
Long-term Prognosis of Cluster Headache: a Retrospective Cohort Study
An observational study of Cluster Headache and Disease Course, run by Samsung Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cluster Headache, Disease Course
- What is being tested?
- Any treatment for cluster headache
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2016to Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with cluster headache
Who may be able to join
- Patients who were diagnosed as cluster headache
- More than 5 years after the first visit
Who cannot join
- Subjects who refused the telephone visit
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul
Mi Ji Lee, MD, 82-2-3410-1895, mirony.lee@samsung.com
About this study
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.
- Conditions
- Cluster Headache, Disease Course
- Being tested
- Any treatment for cluster headache
- Medical subject headings
- Cluster Headache, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Any treatment for cluster headacheDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at least 5 years after the first visit
Changes in the length of active/inactive periods
Measured: at least 5 years after the first visit
Changes in seasonal and diurnal predilections
Measured: at least 5 years after the first visit
Changes in autonomic symptoms
Measured: at least 5 years after the first visit
Changes in treatment responses
Measured: at least 5 years after the first visit
Secondary outcomes (2)
Any depression
Measured: at least 5 years after the first visit
Any suicidal thoughts (active/passive), plans, and attempts
ictal vs interictal
Measured: at least 5 years after the first vis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cluster HeadacheStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chin-Sang Chung, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02895256
- Sponsor's protocol ID
- 2016-04-155
- Status last verified
- Mar 2020
- First submitted
- 4 Sep 2016
- Last updated
- 20 Mar 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Prognosis of Cluster Headache: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT02895256
- Acronym / sponsor ID
- 2016-04-155
- Conditions
- Cluster Headache, Disease Course
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 9 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with cluster headache
Key inclusion criteria (2 listed)
- Patients who were diagnosed as cluster headache
- More than 5 years after the first visit
Key exclusion criteria (1 listed)
- Subjects who refused the telephone visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Any treatment for cluster headache | Drug | – |
Primary outcome
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
2 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cluster Headache and Disease Course, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mi Ji Lee, MD (82-2-3410-1895, mirony.lee@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall prognosis (time frame: at least 5 years after the first visit). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2020.