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.

- Marked levodopa responsiveness at screening per investigator's judgment (e.g., 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 18 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.

- ≥3 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 PD therapy with deep brain stimulation, lesion therapy, gene therapy, or
cell therapy.

- Prior surgical or radiation therapy to the brain or spinal cord.

- Receipt of another investigational therapy or device within 2 years of screening
unless approved by the medical monitor.

Eligibility last updated 8/8/22. Questions regarding updates should be directed to the study team contact.