Determining Patterns In Trial Experiences of Parkinson's Disease Patients

NCT05685329 | Not Yet Recruiting

• 1 other identifier: 87526739
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson Disease

Keywords

Parkinson's Disease; Parkinson's

Outcome Measures

Primary Outcomes (2)

• 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

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

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

Related Publications (3)

• 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.

  PMID: 30704685 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.

  PMID: 32044947 BACKGROUND

• McFarthing K, Rafaloff G, Baptista M, Mursaleen L, Fuest R, Wyse RK, Stott SRW. Parkinson's Disease Drug Therapies in the Clinical Trial Pipeline: 2022 Update. J Parkinsons Dis. 2022;12(4):1073-1082. doi: 10.3233/JPD-229002.

  PMID: 35527571 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative 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: January 5, 2023
• First Posted: January 17, 2023
• Study Start: February 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2026
• Last Updated: June 18, 2023

Record last verified: 2023-06