Status:
ACTIVE_NOT_RECRUITING
Noninterventional Study Evaluating Parkinson's Disease Diary Use
Lead Sponsor:
BlueRock Therapeutics
Conditions:
Parkinson's Disease
Eligibility:
All Genders
39-70 years
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 medi...
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 t...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 29 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2026
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT05363046
Start Date
July 29 2022
End Date
October 1 2026
Last Update
July 31 2024
Active Locations (34)
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1
Mayo Clinic Neurology
Scottsdale, Arizona, United States, 85259
2
David Geffen School of Medicine University of California Los Angeles
Los Angeles, California, United States, 90095
3
University of California, Irvine
Orange, California, United States, 92868
4
University of Colorado
Aurora, Colorado, United States, 80045