Cluster Headache Clinical Trial
Official title:
An Observational Study Assessing the Experience of Patients Undergoing Active Cluster Headache Clinical Trials
NCT number | NCT05978258 |
Other study ID # | 81829797 |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | August 2024 |
Est. completion date | August 2026 |
Historically, participation in clinical studies is highly skewed towards particular demographic groups of people. This research will invite several participants to gather a wide range of information on clinical trial experiences for cluster headache patients. The aim of the study is to identify the factors that limit the ability of a person to enroll in, as well as complete a clinical trial for treatment of cluster headache. The data collected from this study will help improve future outcomes for all cluster headache patients as well as those in under-represented demographic groups.
Status | Not yet recruiting |
Enrollment | 500 |
Est. completion date | August 2026 |
Est. primary completion date | August 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patient has been diagnosed with cluster headache - Patient has access to a home internet connection in order to provide regular updates through the course of the study - Participant must be 18 years of age or older Exclusion Criteria: - Patient has an ECOG score of 4 or higher - Patient is not able to provide consistent digital updates as per study requirements - Patient does not complete or agree to terms outlined in the Informed Consent Form |
Country | Name | City | State |
---|---|---|---|
United States | Power Life Sciences | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Power Life Sciences Inc. |
United States,
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Snoer A, Lund N, Beske R, Hagedorn A, Jensen RH, Barloese M. Cluster headache beyond the pain phase: A prospective study of 500 attacks. Neurology. 2018 Aug 28;91(9):e822-e831. doi: 10.1212/01.wnl.0000542491.92981.03. Epub 2018 Jul 27. — View Citation
Vigano A, Savastano E, Petolicchio B, Toscano M, De Sanctis R, Maestrini I, Di Piero V. A Study of Clinical Features and Risk Factors of Self-Referring Emergency Department Headache Patients: A Comparison with Headache Center Outpatients. Eur Neurol. 2020;83(1):34-40. doi: 10.1159/000505915. Epub 2020 Mar 10. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of patients who decide to enroll in a cluster headache clinical study. | 3 months | ||
Primary | Number of cluster headache patients who remain in clinical research until completion. | 12 months |
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