A Phase 3 Study of TVP-1012 (1 mg) in Early Parkinson's Disease Patients

Inclusion Criteria: Run-in period * 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 with at least two of the following signs: resting tremor, akinesia/bradykinesia, and muscle rigidity. * The participant has a Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II + Part III total score of \>=14 at the start of the run-in period. * The participant has Modified Hoehn \& Yahr stage 1 to 3 at the start of the run-in period. * The participant has the Parkinson's disease diagnosed within 5 years prior to the start of the run-in period. * The participant is an outpatient of either sex aged \>= 30 and \< 80 years. * A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent to 1 month after the last dose of the investigational drug. Treatment period \- The participant has a MDS-UPDRS Part II + Part III total score of \>= 14 at baseline. Exclusion Criteria: Run-in period * 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 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 Mini-Mental State Examination (MMSE) score of \<= 24 at the start of the run-in period. * The participant has known or a history of schizophrenia, major or severe depression, or any other clinically significant psychiatric disease. * The participant has a history of hypersensitivity or allergies to TVP-1012 (including any associated excipients) or selegiline. * The participant has a history of clinically significant hypertension or other reactions associated with ingestion of tyramine-rich food (e.g., cheese, lever, herring, yeast, horsebean, banana, beer or wine). * The participant has a history or concurrent of drug abuse or alcohol dependence. * The participant has received neurosurgical intervention for Parkinson's disease (e.g., pallidotomy, thalamotomy, deep brain stimulation). * The participant has received transcranial magnetic stimulation within 6 months prior to the start of the run-in period * The participant has received amantadine or anticholinergic medication for \>= 180 days. * The participant has received selegiline, a levodopa-containing product or dopamine agonist for \>= 90 days. * The participant has received selegiline, pethidine, tramadol, reserpine or methyldopa within 90 days prior to the start of the run-in period. * The participant has received a levodopa-containing product, dopamine agonist, amantadine or anticholinergic drug within 30 days prior to the start of the run-in period. * The participant has received any psychoneurotic agent or antiemetic medication of dopamine antagonist within 14 days prior to the start of the run-in period. However, the participant has been receiving quetiapine or domperidone with a stable dose regimen for \>= 14 days prior to the start of the run-in period may be included in the study. * The participant has previously received a catechol-O-methyltransferase (COMT) inhibitor, droxidopa, zonisamide or istradefylline. * 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 this study, or within 1 month after the last dose of the investigational drug; 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, * cardiac arrest 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 start of the run-in period, * sever 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 systolic pressure decrease of 30 mmHg or more following postural change from supine/sitting position to standing position), * a history of syncope due to hypotension within 2 years prior to the start 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 who, in the opinion of the investigator or sub-investigator, is unsuitable for any other reason. Treatment period * The participant whose diagonosis of Parkinson's disease is ruled out by dopamine transporter scintigraphy performed during the run-in period if conducted. * The participant has 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.