Noninterventional Study Evaluating Parkinson's Disease Diary Use

July 30, 2024 updated by: BlueRock Therapeutics

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

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.

Study Overview

Status

Active, not recruiting

Conditions

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.

Study Type

Observational

Enrollment (Actual)

194

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Toronto Western Hospital
  • Germany
      • Düsseldorf, Germany, 40225
        • Universitaetsklinikum Duesseldorf AöR
      • Rostock, Germany, 18147
        • Universitätsmedizin Rostock
      • Tübingen, Germany, 72076
        • University Hospital Tuebingen
    • Baden-Württemberg
      • Wolfach, Baden-Württemberg, Germany, 77709
        • Dkd Wiesbaden
    • Bayern
      • Munich, Bayern, Germany, 81377
        • Klinikum der Universität München - Campus Grosshadern
      • Munich, Bayern, Germany, 81675
        • Technischen Universitaet Muenchen (TUM)
      • Würzburg, Bayern, Germany, 97080
        • Universitätsklinikum Würzburg - Medizinische Klinik
    • Hessen
      • Marburg, Hessen, Germany, 35043
        • Klinik und Poliklinik für Neurologie am Standort Marburg
  • Italy
      • Ancona, Italy, 60126
        • AOU Ospedali Riuniti Umberto I - G.M. LANCISI - G. SALESI
      • Padova, Italy, 35128
        • Azienda Ospedale Universita Padova
      • Rome, Italy, 00163
        • IRCCS San Raffaele Pisana
      • Salerno, Italy, 84131
        • AOU OO.RR. San Giovanni di Dio Ruggi d'Aragona
  • Spain
      • Barcelona, Spain, 08041
        • Hospital De La Santa Creu I Sant Pau
      • Pontevedra, Spain, 36071
        • Complexo Hospitalario de Pontevedra (CHOP)
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Valencia, Spain, 46026
        • Hospital Universitario Y Politecnico La Fe
    • Bilbao
      • Santurtzi, Bilbao, Spain, 48980
        • Hospital San Juan de Dios
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic Neurology
    • California
      • Los Angeles, California, United States, 90095
        • David Geffen School of Medicine University of California Los Angeles
      • Orange, California, United States, 92868
        • University of California, Irvine
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Movement Disorders Center of Boca Raton
      • Miami, Florida, United States, 33136
        • University of Miami Health System
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Parkinson's Disease and Movement Disorders Center at Northwestern University Feinberg School of Medicine
    • Kansas
      • Kansas City, Kansas, United States, 66103
        • University of Kansas Medical Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University Of Louisville
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
    • New York
      • New York, New York, United States, 10019
        • Mount Sinai West
      • New York, New York, United States, 10021
        • Weill Cornell Medicine - New York Presbyterian Hospital
      • Rochester, New York, United States, 14618
        • University of Rochester Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Washington
      • Kirkland, Washington, United States, 98034
        • Evergreen Health Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

39 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Parkinson's disease patients whose medications do not provide adequate control of their symptoms.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Group A
Participants will complete the PD diary on 3 consecutive days in 1 week.
Group B
Participants will complete the PD diary on 2 consecutive days in each of 2 consecutive weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Good ON-time as measured by the PD Diary.
Time Frame: 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.
Baseline, 3, 6, 12, 18 and 24 months.
Individual participant variability for ON-time without troublesome dyskinesia (Good ON-time) as measured by the PD diary.
Time Frame: 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.
Baseline, 3, 6, 12, 18 and 24 months.
Proportion of valid PD Diaries.
Time Frame: Baseline, 3, 6, 12, 18 and 24 months.
Proportion of valid PD Diaries.
Baseline, 3, 6, 12, 18 and 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BlueRock Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2022

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

May 3, 2022

First Submitted That Met QC Criteria

May 3, 2022

First Posted (Actual)

May 5, 2022

Study Record Updates

Last Update Posted (Actual)

July 31, 2024

Last Update Submitted That Met QC Criteria

July 30, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRT-DA01-NIS-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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