A Close Examination of Patient Experiences in Cluster Headache Clinical Research

NCT ID: NCT05978258

Last Updated: 2023-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-31

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cluster Headache

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Power Life Sciences Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael B Gill

Role: STUDY_DIRECTOR

Power Life Sciences Inc.

Locations

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Power Life Sciences

San Francisco, California, United States

Site Status

Countries

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United States

Central Contacts

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Michael B Gill

Role: CONTACT

(415) 900-4227

Facility Contacts

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Michael B Gill

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 34820736 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30054443 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32155625 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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81829797

Identifier Type: -

Identifier Source: org_study_id

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