A Close Examination of Patient Experiences in Cluster Hea... | NCT05978258

Studies
A Close Examination of Patient Experiences in Cluster Headache Clinical Research

NCT05978258

Sponsor

Power Life Sciences Inc.

Status

Not yet recruiting

Last Update Posted

Aug 7, 2023Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Cluster Headache

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2024Estimated

Primary Completion Date

Aug 2025Estimated

Completion Date

Aug 2026Estimated

First Submitted Date

Jul 28, 2023

First Submission Date that Met QC Criteria

Jul 28, 2023

First Posted Date

Aug 7, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 28, 2023

Last Update Posted Date

Aug 7, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michael B Gill	Contact	(415) 900-4227		bask@withpower.com

Overall Officials

Name	Affiliation	Role
Michael B Gill	Power Life Sciences Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Power Life Sciences		San Francisco	California	94107	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34820736	Background	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.
30054443	Background

ID	Term
D051303	Trigeminal Autonomic Cephalalgias
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases