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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety 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-jRCT2080222708

Enrollment

244

Registered

2015-01-06

Start date

2015-02-07

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 a diagnosis of Parkinson's disease with at least two of the following signs: resting tremor, akinesia/hypokinesia, 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. -The participant has Modified Hoehn & Yahr stage 1 to 3. -The participant has the Parkinson's disease diagnosed within 5 years. -The participant is an outpatient of either sex aged >= 30 and < 80 years

Exclusion criteria

Exclusion criteria: -The participant has unstable systemic disease. -The participant has Mini-Mental State Examination (MMSE) score of = 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 -The participant has received a levodopa-containing product, dopamine agonist, amantadine or anticholinergic drug within 30 days. -The participant has received any psychoneurotic agent or antiemetic medication of dopamine agonist within 14 days. However, the participant has been receiving quetiapine or domperidone with a stable dose regimen for >= 14 days 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 excluded medications or treatments. -The participant whose diagonosis of Parkinson's disease is ruled out by elective dopamine transporter scintigraphy. -The participant has laboratory data meeting any of the following at the start: -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 Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II + Part III total score Timeframe: Up to Weeks 28 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 Change in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II + Part III total score Timeframe: Up to Weeks 28 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.

—

Secondary

Measure	Time frame
safety efficacy MDS-UPDRS Part II + Part III total score, MDS-UPDRS Part I total score, MDS-UPDRS Part II total score, MDS-UPDRS Part III total score Timeframe: Up to Weeks 28	—

Countries

Japan

Outcome results

None listed

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