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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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 Rocío
      • Valencia, Spain, 46026
        • Hospital Universitario y Politécnico 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 29, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 3, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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