A Long-term, Phase 3 Study of TVP-1012 (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 received a levodopa combination drug for >= 1 month at the start of the run-in period and has either of the following.
• Wearing off phenomenon
• Decreased response to levodopa combination drugs
• The participant has been receiving a levodopa combination drug a stable dose regimen since the start of the run-in period.
• The participant is an outpatient of either sex aged >= 30 and = 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 virus (HIV) carrier], or hepatitis [including viral hepatitis carrier such as hepatitis B surface (HBs) antigen or hepatitis C antibody (HCV) positive]. However, the participant who has a negative result for HCV antigen or HCV-RNA can be included in the study.
• The participant with laboratory data meeting any of the following at the start of the run-in period:
• Creatinine >= 2 x upper limit of normal (ULN)
• Total bilirubin >= 2 x ULN
• ALT or AST >= 1.5 x ULN
• ALP >= 3 x ULN
• The participant has received any of the prohibited concomitant medications or treatments during the run-in period
• The participant who, in the opinion of the investigator or sub-investigator, is unsuitable for any other reason.