A Study of CST-103 Co-administered With CST-107 in Subjects With Parkinson's Disease Having Freezing of Gait (CLIN-012)

Inclusion Criteria

• •Male or female subjects ≥ 30 and ≤ 80 years of age, at time of informed consent.
• •Diagnosed with Parkinson's Disease, as defined by the United Kingdom Parkinson Disease Brain Bank criteria.
• •At least 3 months incidence of typical freezing of gait (FOG) symptoms defined as the inability to move the feet despite the intention to walk including at least one of the following FOG patterns: start hesitancy, freezing at making turns or when passing through a doorway, spontaneous freezing during continued walking, or freezing of gait related to a simultaneous mental or physical activity.
• •Freeze at least once per week (minimum score of 2 on item 3 of the FOG-Q) for at least 2 seconds (minimum score of 1 on item 4 of FOG-Q).
• •Willing to attend assessment visits in the practically defined Off state having withdrawn from dopaminergic therapy: L-dopa preparations from midnight, Dopamine Agonists/Monoamine Oxidase-B Inhibitor for 36 hours prior to visit. Patients with device assisted therapies (i.e. Deep Brain Stimulation, L-dopa intestinal gel or subcutaneous apomorphine) to withdraw therapy for a minimum 30 minute period (maximum 2 hours) to achieve their clinically agreed Off state.
• •Unless confirmed to be azoospermic (vasectomized or secondary to medical cause), males must agree to use a male condom from Day 1 throughout the study when having penile-vaginal intercourse with a woman of childbearing potential who is not currently pregnant. Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a condom during each episode of penile-vaginal penetration until after the Follow-Up Visit.
• •Females of childbearing potential (i.e., not postmenopausal or surgically sterile) who have a male partner must have a negative serum pregnancy test result and must agree to one of the following from start of Screening through 30 days after the last study medication administration: use a reliable method of birth control, or monogamous relationship with a male partner of confirmed sterility, or practice complete abstinence.
• •Females of non-childbearing potential may be enrolled if it is documented that they are postmenopausal.
• •Body weight greater or equal to 50 kg and body mass index (BMI) between 18 and 35 kg/m2, inclusive at Screening.
• •Stable medical conditions for 3 months prior to Screening visit (e.g., controlled hypertension, dyslipidemia).
• •Willing to follow the protocol requirements and comply with protocol restrictions.
• •Capable of providing informed consent and complying with study procedures (completion of self-assessment rating scales and use of wearable devices). Subjects who are unable to provide consent may use a Legally Authorized Representative.