Noninterventional Study Evaluating Parkinson's Disease Diary Use
- Conditions
- Parkinson's Disease
- Registration Number
- NCT05363046
- Lead Sponsor
- BlueRock Therapeutics
- Brief 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 194
Not provided
- PD with risk of recurrent falls or only tremor-based symptoms
- Diagnosis of primary mitochondrial disorder, epilepsy, stroke, multiple sclerosis, or clinical features suggestive of a neurodegenerative disease other than PD such as Alzheimer's disease
- Any available evidence inconsistent with dopamine deficiency (eg, 18F-DOPA positron emission tomography [PET] or dopamine transporter single-photon emission computed tomography [DAT-SPECT] imaging if performed)
- Moderately severe dyskinesia per investigator's judgment
- Receiving dopamine receptor-blocking agents, including typical neuroleptics, prochlorperazine, and metoclopramide at the time of screening or within 3 months prior to screening
- Treatment with intrajejunal or subcutaneous infusion therapies for PD within 2 months of screening
- History of gene therapy or cell therapy
- Prior surgical or radiation therapy to the brain, including deep brain stimulation and lesion therapy, or prior history of intradural spinal cord surgery
- Receipt of another investigational therapy or device within 2 years of screening unless approved by the medical monitor
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Good ON-time as measured by the PD Diary. Baseline, 3, 6, 12, 18 and 24 months. Standard deviation of change in ON-time without troublesome dyskinesia (Good ON-time) as measured by the PD diary.
Individual participant variability for ON-time without troublesome dyskinesia (Good ON-time) as measured by the PD diary. Baseline, 3, 6, 12, 18 and 24 months. Within-subject coefficient of variation for ON-time without troublesome dyskinesia (Good ON-time) as measured by the PD diary.
Proportion of valid PD Diaries. Baseline, 3, 6, 12, 18 and 24 months. Proportion of valid PD Diaries.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (34)
Mayo Clinic Neurology
🇺🇸Scottsdale, Arizona, United States
David Geffen School of Medicine University of California Los Angeles
🇺🇸Los Angeles, California, United States
University of California, Irvine
🇺🇸Orange, California, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Movement Disorders Center of Boca Raton
🇺🇸Boca Raton, Florida, United States
University of Miami Health System
🇺🇸Miami, Florida, United States
Parkinson's Disease and Movement Disorders Center at Northwestern University Feinberg School of Medicine
🇺🇸Chicago, Illinois, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
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