Clinical Trials

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.
• Ongoing marked levodopa responsiveness per investigator’s judgment.
• 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 ≥1 month prior to screening, or demonstrated intolerance of 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.
• Modified 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
• Able to give informed consent for study. participation and sign informed consent form.

Exclusion Criteria:

• PD with risk of recurrent falls or only tremor-based symptoms per investigator’s judgment.
• 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 (e.g., 6-[18F]fluoro-L-3,4-dihydroxyphenylalanine [18F-DOPA] positron emission tomography [PET] or dopamine transporter single-photon emission computed tomography [DAT-SPECT] imaging if performed).
• Any current or relevant previous history of serious, severe, or unstable physical, neurological, or psychiatric illness that may interfere with the patient’s participation in the study, patient’s safety, or assessment of endpoints per investigator’s judgment (including significant depression, psychosis, anxiety, cognitive impairment, impulse control disorder, dopamine dysregulation syndrome, substance abuse, significant and serious concomitant medical condition that is poorly controlled, or significant concomitant medical condition limiting life expectancy).
• Moderate to extreme dyskinesia per investigator’s judgment

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 12/20/23. Questions regarding updates should be directed to the study team contact.