Determining Patterns In Trial Experiences of Parkinson's... | NCT05685329

Studies
Determining Patterns In Trial Experiences of Parkinson's Disease Patients

NCT05685329

Sponsor

Power Life Sciences Inc.

Status

Unknown status

Last Update Posted

Jun 18, 2023Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Parkinson Disease

Interventions

Not provided

Countries

Not provided

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

Jun 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2024Estimated

Primary Completion Date

Feb 2025Estimated

Completion Date

Feb 2026Estimated

First Submitted Date

Jan 5, 2023

First Submission Date that Met QC Criteria

Jan 5, 2023

First Posted Date

Jan 17, 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

Jun 15, 2023

Last Update Posted Date

Jun 18, 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 study will invite several participants to gather a wide range of information on clinical trial experiences for Parkinson's Disease 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 Parkinson's Disease.

The data collected from this study will help improve future outcomes for all Parkinson's Disease 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
Number of patients who decide to enroll in an Parkinson's Disease clinical trial		3 months
Rate of patients who remain in Parkinson's Disease clinical trial to trial completion		12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient plans to participate in an interventional clinical trial for the condition of Parkinson's Disease
Patient has been diagnosed with a type of Parkinson's Disease
Patient is at least 50 to 80 years of age
Patient has access to a home internet connection in order to provide regular updates through the course of the study

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

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with Parkinson's Disease who are actively considering enrolling in an interventional clinical trial for said condition, but have not yet completed enrollment and randomization phases in said clinical trial.

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

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30704685	Background	Reich SG, Savitt JM. Parkinson's Disease. Med Clin North Am. 2019 Mar;103(2):337-350. doi: 10.1016/j.mcna.2018.10.014. Epub 2018 Dec 3.
32044947	Background	Armstrong MJ, Okun MS. Diagnosis and Treatment of Parkinson Disease: A Review. JAMA. 2020 Feb 11;323(6):548-560. doi: 10.1001/jama.2019.22360.

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases