NCT05363046

Noninterventional Study Evaluating Parkinson's Disease Diary Use

A Multi-center, Noninterventional Study Evaluating Variability, Reliability, and Compliance for the Parkinson's Disease Diary

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 194 (actual)
• Sponsor: BlueRock Therapeutics · Industry
• Sex: All
• Age: 39 Years – 70 Years
• Healthy volunteers: —

Summary

This study aims to evaluate the impact of the frequency of assessments on the variability over time, reliability, and compliance for the Parkinson's disease (PD) diary in patients with PD in whom medications do not provide adequate control of symptoms.

Detailed description

This is a global, multi-center, noninterventional study of patients with PD aged ≥39 to ≤70 years under standard-of-care treatment that will enroll a minimum of approximately 150 participants and up to 400 participants. Participants will be assigned (1:1) to complete the PD diary either on 3 consecutive days in 1 week (Group A) or 2 consecutive days in each of 2 consecutive weeks (Group B) for a given study visit. During the study, data are collected on motor function, quality of life, and use of PD medications at Baseline and at 3, 6, 12, 18, and 24 months.

Conditions

• Parkinson's Disease

Timeline

• Start date: 2022-07-29
• Primary completion: 2025-10-01
• Completion: 2026-10-01
• First posted: 2022-05-05
• Last updated: 2024-07-31

Locations

34 sites across 5 countries: United States, Canada, Germany, Italy, Spain