Noninterventional Study Evaluating Parkinson's Disease Diary Use

Running, not enrolling

Conditions studied: Parkinson's Disease

In brief

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.

Key facts

Study ID

NCT05363046

Run by

BlueRock Therapeutics

People needed

194

Starts

2022-07-29

Expected to finish

2026-10-01

Last updated by the study team

2024-07-31

Who can join

Age: 39 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥39 to ≤70 years of age at signing of informed consent
• Diagnosis of clinically established PD as defined by the Movement Disorder Society (MDS) Clinical Diagnostic Criteria for PD
• Marked levodopa responsiveness at screening per investigator's judgment (eg, an estimated ≥30% improvement of MDS-UPDRS Part III score in the off-medication versus on-medication state)
• A minimum of 3 years and a maximum of 10 years from time of PD diagnosis to the date of screening
• Receiving optimized and stable PD medical therapy for ≥1 month prior to screening or demonstrated intolerance to PD medications per investigator's judgment in agreement with the medical monitor
• ≥2 hours of average daily OFF-time assessed within 3 months of screening by PD diary or per investigator's judgment
• Hoehn and Yahr Stage of 1 to 3 while on PD medication assessed within 3 months of screening or at screening
• Normal cognition as determined by the investigator after review of relevant testing (eg, Montreal Cognitive Assessment score of ≥26, or ≥22 if no significant cognitive impairment as determined by neuropsychological testing)

You may not qualify if…

• 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

Where it is running

• 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
• Mount Sinai West — New York, New York, United States
• Weill Cornell Medicine - New York Presbyterian Hospital — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Evergreen Health Medical Center — Kirkland, Washington, United States
• Toronto Western Hospital — Toronto, Ontario, Canada
• Dkd Wiesbaden — Wolfach, Baden-Wurttemberg, Germany
• Klinikum der Universität München - Campus Grosshadern — Munich, Bavaria, Germany
• Technischen Universitaet Muenchen (TUM) — Munich, Bavaria, Germany
• Universitätsklinikum Würzburg - Medizinische Klinik — Würzburg, Bavaria, Germany
• Klinik und Poliklinik für Neurologie am Standort Marburg — Marburg, Hesse, Germany
• Universitaetsklinikum Duesseldorf AöR — Düsseldorf, Germany
• Universitätsmedizin Rostock — Rostock, Germany
• University Hospital Tuebingen — Tübingen, Germany

Full record on ClinicalTrials.gov

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