A Close Examination of Patient Experiences in Cluster Headache Clinical Research

NCT05978258 | Not Yet Recruiting

• 1 other identifier: 81829797
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Cluster Headache

Keywords

Cluster Headache

Outcome Measures

Primary Outcomes (2)

• 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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with cluster headache who are actively considering enrolling in a clinical trial for the said condition, but have not yet completed enrollment and randomization phases.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Power Life Sciences Inc.: lead

Study Sites (1)

Power Life Sciences

San Francisco, California, 94107, United States

Location

Related 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.

  PMID: 34820736 BACKGROUND

• 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.

  PMID: 30054443 BACKGROUND

• 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.

  PMID: 32155625 BACKGROUND

MeSH Terms

Conditions

Cluster Headache

Condition Hierarchy (Ancestors)

Trigeminal Autonomic Cephalalgias; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Michael B Gill

  Power Life Sciences Inc.

  STUDY DIRECTOR

Central Study Contacts

Michael B Gill

CONTACT

(415) 900-4227; bask@withpower.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 7, 2023
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 7, 2023

Record last verified: 2023-07

Locations

US (1)