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

A Multicenter, Open-label, Long-term, Extension, Phase 3 Study to Evaluate the Safety and Efficacy of TVP-1012 at 1 mg in Early Parkinson's Disease Patients Not Treated with Levodopa

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222709

Enrollment

198

Registered

2015-01-06

Start date

2015-07-10

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 INN of investigational material : - Therapeutic category code : 116 Antiperkinsonism agents Dosage and Administration for Investigational materi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -The participant has completed the preceding study. -The participant has shown no safety issues during the study treatment in the preceding study, in the opinion of the investigator or subinvestigator.

Exclusion criteria

Exclusion criteria: -The participant has undergone blood collection of >= 400 mL within 90 days prior to the start of treatment in this study. -The participant is required to take any of the excluded medications or treatments. -The participant is required surgery or hospitalization for surgery during the study period.

Design outcomes

Primary

Measure	Time frame
safety Adverse events (AEs) Timeframe: Up to 26 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 26 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, Mean daily off-time, Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II + Part III total score Timeframe: Up to 26 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, Mean daily off-time, Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II + Part III total score Timeframe: Up to 26 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