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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2/3 Study to Evaluate the Efficacy and Safety of TVP-1012 at 0.5 mg or 1 mg in Levodopa Treated Parkinson's Disease Patients with wearing off

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222707

Enrollment

404

Registered

2015-01-06

Start date

2015-01-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease with wearing off phenomenon

Interventions

investigational material(s) Generic name etc : TVP-1012 (1 mg/day) or TVP-1012 (0.5 mg/day) INN of investigational material : - Therapeutic category code : 116 Antiperkinsonism agents Dosage and Admin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -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). -The participant has wearing off phenomenon and has been continuously receiving a levodopa combination drug for >= 6 months. -The participant has been receiving a levodopa combination drug without change in the dose regimen (dosing frequency, at least 3 times a day). -The participant has been receiving entacapone with a stable dose regimen. -The participant has been receiving a dopamine agonist, anticholinergic drug, amantadine, droxidopa, istradefylline, or zonisamide with a stable dose regimen. -The participant is an outpatient of either sex aged >= 30 and = 2.5 hours.

Exclusion criteria

Exclusion criteria: -The participant has unstable systemic disease. -The participant has severe dyskinesia. -The participant has Mini-Mental State Examination (MMSE) score of == 14 days may be included in the study. -The participant is required to take any of the excluded medications or treatments. -The participant has laboratory data meeting any of the following: -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 excludeded medications or treatments.

Design outcomes

Primary

Measure	Time frame
safety efficacy Change in the mean daily off-time Timeframe: Up to 28 weeks	—

Secondary

Measure	Time frame
safety efficacy Mean daily off-time, Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II total score, MDS-UPDRS Part III total score, Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index score and scores for individual domains Timeframe: Up to 28 weeks MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The scales are now titled; (Part I) nonmotor experiences of daily living (13 items), (Part II) motor experiences of daily living (13 items), (Part III) motor examination (18 items), and (Part IV) motor complications (six items). Each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. PDQ-39 is a self-administered questionnaire. PDQ-39 comprises of 39 questions, relating to eight key areas of health and daily activities, including both Motor and Non-motor symptoms. It is scored on a scale of zero to 100, with lower scores indicating better health and high scores more severe symptoms.	—

Measure

Time frame

safety efficacy Mean daily off-time, Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II total score, MDS-UPDRS Part III total score, Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index score and scores for individual domains Timeframe: Up to 28 weeks MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The scales are now titled; (Part I) nonmotor experiences of daily living (13 items), (Part II) motor experiences of daily living (13 items), (Part III) motor examination (18 items), and (Part IV) motor complications (six items). Each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. PDQ-39 is a self-administered questionnaire. PDQ-39 comprises of 39 questions, relating to eight key areas of health and daily activities, including both Motor and Non-motor symptoms. It is scored on a scale of zero to 100, with lower scores indicating better health and high scores more severe symptoms.

—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026