Noninterventional Study Evaluating Parkinson's Disease Diary Use
Recruitment Status: Recruiting
Start Date: July 29, 2022
End Date: October 01, 2026
- ≥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
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Conditions:
- Parkinson Disease