Noninterventional Study Evaluating Parkinson's Disease Diary Use

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05363046
• Other study ID #: BRT-DA01-NIS-001
• Status: Recruiting
• Start date: July 29, 2022
• Est. completion date: October 2026

Study information

• Verified date: September 2023
• Source: BlueRock Therapeutics
• Contact: Marta E Farino-Silva
• Phone: 1-617-930-9292
• Email: clinicaltrials[@]bluerocktx.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: October 2026
• Est. primary completion date: October 2025
• Gender: All
• Age group: 39 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario
Germany	Universitaetsklinikum Duesseldorf AöR	Düsseldorf
Germany	Klinik und Poliklinik für Neurologie am Standort Marburg	Marburg	Hessen
Germany	Klinikum der Universität München - Campus Grosshadern	Munich	Bayern
Germany	Technischen Universitaet Muenchen (TUM)	Munich	Bayern
Germany	Universitätsmedizin Rostock	Rostock
Germany	University Hospital Tuebingen	Tübingen
Germany	Dkd Wiesbaden	Wolfach	Baden-Württemberg
Germany	Universitätsklinikum Würzburg - Medizinische Klinik	Würzburg	Bayern
Italy	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
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Complexo Hospitalario de Pontevedra (CHOP)	Pontevedra
Spain	Hospital San Juan de Dios	Santurtzi	Bilbao
Spain	Hospital Universitario Virgen del Rocio	Sevilla
Spain	Hospital Universitario Y Politécnico La Fe	Valencia
United States	University of Colorado	Aurora	Colorado
United States	Movement Disorders Center of Boca Raton	Boca Raton	Florida
United States	Tufts Medical Center	Boston	Massachusetts
United States	Parkinson's Disease and Movement Disorders Center at Northwestern University Feinberg School of Medicine	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Evergreen Health Medical Center	Kirkland	Washington
United States	David Geffen School of Medicine University of California Los Angeles	Los Angeles	California
United States	University of Louisville	Louisville	Kentucky
United States	University of Miami Health System	Miami	Florida
United States	Vanderbilt University Medical Center	Nashville	Tennessee
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 California, Irvine	Orange	California
United States	University of Rochester Medical Center	Rochester	New York
United States	Mayo Clinic Neurology	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
BlueRock Therapeutics

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Italy,  Spain, 

Outcome

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