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Active, not recruiting Observational

Noninterventional Study Evaluating Parkinson's Disease Diary Use

NCT05363046 · tracked via the Priya Life Science Spain tracker
Phase
Observational
Started
2022-07-29
Last updated
2024-07-31

Condition(s) studied

Parkinson's Disease

Study 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.

Eligibility

Sex
ALL
Min age
39 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria * ≥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) Exclusion Criteria: * 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

Primary outcome measure(s)

  • 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.

Trial sites (34)

FacilityCityRegionStatus
Mayo Clinic Neurology Scottsdale Arizona
David Geffen School of Medicine University of California Los Angeles Los Angeles California
University of California, Irvine Orange California
University of Colorado Aurora Colorado
Movement Disorders Center of Boca Raton Boca Raton Florida
University of Miami Health System Miami Florida
Parkinson's Disease and Movement Disorders Center at Northwestern University Feinberg School of Medicine Chicago Illinois
University of Kansas Medical Center Kansas City Kansas
University of Louisville Louisville Kentucky
Tufts Medical Center Boston Massachusetts
Mount Sinai West New York New York
Weill Cornell Medicine - New York Presbyterian Hospital New York New York
University of Rochester Medical Center Rochester New York
Cleveland Clinic Cleveland Ohio
Vanderbilt University Medical Center Nashville Tennessee
Evergreen Health Medical Center Kirkland Washington
Toronto Western Hospital Toronto Ontario
Dkd Wiesbaden Wolfach Baden-Wurttemberg
Klinikum der Universität München - Campus Grosshadern Munich Bavaria
Technischen Universitaet Muenchen (TUM) Munich Bavaria
Universitätsklinikum Würzburg - Medizinische Klinik Würzburg Bavaria
Klinik und Poliklinik für Neurologie am Standort Marburg Marburg Hesse
Universitaetsklinikum Duesseldorf AöR Düsseldorf Germany
Universitätsmedizin Rostock Rostock Germany
University Hospital Tuebingen Tübingen Germany
AOU Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi Ancona Italy
Azienda Ospedale Università Padova Padova Italy
IRCCS San Raffaele Pisana Rome Italy
AOU OO.RR. San Giovanni di Dio Ruggi d'Aragona Salerno Italy
Hospital San Juan de Dios Santurtzi Bilbao
Hospital de la Santa Creu i Sant Pau Barcelona Spain
Complexo Hospitalario de Pontevedra (CHOP) Pontevedra Spain
Hospital Universitario Virgen del Rocio Seville Spain
Hospital Universitario Y Politécnico La Fe Valencia Spain
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05363046 on ClinicalTrials.gov ↗ ← All trials in Spain