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Clinical Trial Details — Status: Not yet recruiting

Administrative data

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

Study information

Verified date July 2023
Source Power Life Sciences Inc.
Contact Michael B Gill
Phone (415) 900-4227
Email bask@withpower.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Power Life Sciences San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
Power Life Sciences Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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

Outcome

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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