Study Assessing Efficacy and Safety of AKST4290 in Subjects With Parkinson's Disease on Stable Dopaminergic Treatment
Study Assessing Efficacy and Safety of AKST4290 in Subjects With Parkinson's Disease on Stable Dopaminergic Treatment
This study will evaluate the efficacy and safety of AKST4290 in subjects with Parkinson's
 Disease who are currently on stable dopaminergic treatment.
Key Inclusion Criteria:

 -  Diagnosis of clinically established or clinically probable PD according to MDS-PD
 criteria with at least 1 year of PD symptoms.

 -  Modified Hoehn and Yahr ≤2.5.

 -  Have notable motor worsening during off-medication state.

 -  Clear-cut improvement of motor response to levodopa medications, as assessed by the
 investigator.

 -  Must be on stable dopaminergic therapy (e.g., levodopa, dopamine agonists, monoamine
 oxidase inhibitors, catechol-O-methyl transferase inhibitors, amantadine), for at
 least 8 weeks prior to enrollment and remain on stable dose during the 12-week
 treatment period.

 -  Female subjects must not be pregnant or breastfeeding. Women of childbearing potential
 (WOCBP) must have a negative pregnancy test at Screening. WOCBP must agree to use
 highly effective contraception prior to study entry. Male subjects must be willing to
 use a barrier method of contraception.

 Key Exclusion Criteria:

 -  Secondary or atypical parkinsonian syndromes, for example, patients with parkinsonism
 from encephalitis, metabolic disorders, vascular parkinsonism, drug-induced
 parkinsonism, multiple system atrophy, corticobasal ganglia degeneration, progressive
 supranuclear palsy, Lewy body dementia.

 -  History of any brain surgery for PD (e.g., pallidotomy, deep brain stimulation, or
 fetal tissue transplant).

 -  Conditions affecting the peripheral or central nervous system, unless related to PD,
 that would affect the ability to adequately perform the MDS-UPDRS and motor
 assessments: i.e., severe sensory neuropathy affecting arm or leg function, or stroke
 affecting motor or gait function.

 -  Significant alcohol or drug abuse within past 2 years.

 -  Based on ECG reading, subjects with a risk of QT prolongation.

 NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.