A long-term, Phase 3 Study of TVP-1012 (1 mg) in Levodopa Treated Parkinson's Disease Patients

A Multicenter, Open-label, Long-term, Phase 3 Study to Evaluate the Safety and Efficacy of TVP-1012 at 1 mg in Levodopa Treated Parkinson's Disease Patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222710

Enrollment

222

Registered

2015-01-06

Start date

2015-02-03

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

Interventions

investigational material(s) Generic name etc : TVP-1012 (1 mg/day) with levodopa INN of investigational material : - Therapeutic category code : 116 Antiperkinsonism agents Dosage and Administration f

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 received a levodopa combination drug for >= 1 month and has either of the following. -Wearing off phenomenon -Decreased response to levodopa combination drugs -The participant has received a levodopa combination drug without change in the dose regimen. -The participant is an outpatient of either sex aged >= 30 and < 80 years.

Exclusion criteria

Exclusion criteria: -The participant has Modified Hoehn & Yahr stage 5 (or stage 5 at eather on-time or off-time for the participant with wearing off phenomenon). -The participant has severe dyskinesia. -The participant has unstable systemic disease. -The participant has a Mini-Mental State Examinations (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 with 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 excluded medications or treatments.

Design outcomes

Primary

Measure	Time frame
safety Adverse events (AEs) Timeframe: Up to 54 Weeks An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.	—

Measure

Time frame

safety Adverse events (AEs) Timeframe: Up to 54 Weeks An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.

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Secondary

Measure	Time frame
safety efficacy Clinical laboratory test values, vital signs, electrocardiogram (ECG), weight, Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II total score, MDS-UPDRS Part III total score, Mean daily off-time Timeframe: Up to 54 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.	—

Measure

Time frame

safety efficacy Clinical laboratory test values, vital signs, electrocardiogram (ECG), weight, Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II total score, MDS-UPDRS Part III total score, Mean daily off-time Timeframe: Up to 54 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.

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Countries

Japan

Outcome results

None listed

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