A Close Examination of Patient Experiences in Cluster Headache Clinical Research
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- Rate of patients who decide to enroll in a cluster headache clinical study. [3 months]
- Number of cluster headache patients who remain in clinical research until completion. [12 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient has been diagnosed with cluster headache
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Patient has access to a home internet connection in order to provide regular updates through the course of the study
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Participant must be 18 years of age or older
Exclusion Criteria:
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Patient has an ECOG score of 4 or higher
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Patient is not able to provide consistent digital updates as per study requirements
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Patient does not complete or agree to terms outlined in the Informed Consent Form
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Power Life Sciences | San Francisco | California | United States | 94107 |
Sponsors and Collaborators
- Power Life Sciences Inc.
Investigators
- Study Director: Michael B Gill, Power Life Sciences Inc.
Study Documents (Full-Text)
More Information
Publications
- Merli E, Asioli GM, Favoni V, Zenesini C, Mascarella D, Sartori A, Cortelli P, Cevoli S, Pierangeli G. Great occipital nerve long-acting steroid injections in cluster headache therapy: an observational prospective study. J Neurol. 2022 Apr;269(4):2193-2199. doi: 10.1007/s00415-021-10884-0. Epub 2021 Nov 25.
- 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.
- 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.
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