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Noninterventional Study Evaluating Parkinson's Disease Diary Use

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ClinicalTrials.gov Identifier: NCT05363046
Recruitment Status : Recruiting
First Posted : May 5, 2022
Last Update Posted : September 13, 2023
Sponsor:
Information provided by (Responsible Party):
BlueRock Therapeutics

Study Description
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Brief 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.

Condition or disease
Parkinson's Disease

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 Design
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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-center, Noninterventional Study Evaluating Variability, Reliability, and Compliance for the Parkinson's Disease Diary
Actual Study Start Date : July 29, 2022
Estimated Primary Completion Date : October 2025
Estimated Study Completion Date : October 2026

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Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Proportion of valid PD Diaries. [ Time Frame: Baseline, 3, 6, 12, 18 and 24 months. ]
    Proportion of valid PD Diaries.


Eligibility Criteria
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Ages Eligible for Study:   39 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Parkinson's disease patients whose medications do not provide adequate control of their symptoms.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05363046


Contacts
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Contact: Marta E Farino-Silva 1-617-930-9292 clinicaltrials@bluerocktx.com

Locations
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Sponsors and Collaborators
BlueRock Therapeutics
More Information
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Responsible Party: BlueRock Therapeutics
ClinicalTrials.gov Identifier: NCT05363046    
Other Study ID Numbers: BRT-DA01-NIS-001
First Posted: May 5, 2022    Key Record Dates
Last Update Posted: September 13, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases