A Phase 2/3 Study of TVP-1012 at 0.5 mg or 1 mg in Levodopa Treated Parkinson's Disease Participants

Inclusion Criteria

• In the opinion of the investigator or sub-investigator, the participant is capable of understanding and complying with protocol requirements.
• The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
• The participant has a diagnosis of Parkinson's disease according to the diagnostic criteria of the UK Parkinson's Disease Society Brain Bank.
• The participant has Modified Hoehn & Yahr stage 2 to 4 (in the "Off" state) at the start of the run-in period.
• The participant has wearing off phenomenon and has been continuously receiving a levodopa combination drug for >= 6 months prior to the start of the run-in period.
• The participant has been receiving a levodopa combination drug with a stable dose regimen (dosing frequency, at least 3 times a day) since the start of the run-in period.
• For participants receiving eantacapone concomitantly, the participant has been receiving entacapone with a stable dose regimen from the start of the run-in period.
• For participants receiving a dopamine agonist, anticholinergic drug, amantadine, droxidopa, istradefylline, or zonisamide concomitantly, the participant has been receiving those drugs with a stable dose regimen since 14 days prior to the start of the run-in period.
• The participant is an outpatient of either sex aged >= 30 and = 2.5 hours at the end of the run-in period

Exclusion Criteria

• The participant has received any investigational medication within 90 days prior to the start of the run-in period.
• The participant has received TVP-1012 in the past.
• The participant is a study site employee, an immediate family member, or in a dependent relationship with a study site employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling) or may consent under duress.
• Participant has donated 400 mL or more of his or her blood volume within 90 days prior to the start of the run-in period.
• The participant has unstable systemic disease.
• The participant has severe dyskinesia.
• The participant has Mini-Mental State Examination (MMSE) score of = 14 days prior to the start of the run-in period may be included in the study.
• The participant is required to take any of the prohibited concomitant medications or treatments.
• If female, the participant is pregnant or lactating or intending to become pregnant during, or within 1 month after the last administration of study medication in this study; or intending to donate ova during such time period.
• The participant has clinically significant neurologic, cardiovascular, pulmonary, hepatic (including mild cirrhosis), renal, metabolic, gastrointestinal, urological, endocrine, or hematological disease.
• The participant has clinically significant or unstable brain or cardiovascular disease, such as:
• clinically significant arrhythmia or cardiac valvulopathy,
• heart failure of NYHA Class II or higher,
• concurrent or a history of ischemic cardiac disease within 6 months prior to the start of the run-in period,
• concurrent or a history of clinically significant cerebrovascular disease within 6 months prior to the stat of the run-in period,
• severe hypertension (systolic blood pressure of 180 mmHg or higher, or diastolic blood pressure of 110 mmHg or higher),
• clinically significant orthostatic hypotension (including those with diastolic pressure decrease of 30 mmHg or more following postural change from supine/sitting position to standing position), or
• a history of syncope due to hypotension within 2 years prior to the stat of the run-in period.
• The participant is required surgery or hospitalization for surgery during the study period.
• Participant has a history of cancer within 5 years prior to the start of the run-in period, except cervix carcinoma in situ which has completely cured.
• The participant has acquired immunodeficiency syndrome (AIDS) [including human immunodeficiency