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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

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

Yes

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Takeda Pharmaceutical Company Limited

https://www.takeda.com/who-we-are/contact-us/

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Takeda Pharmaceutical Company Limited

https://www.takeda.com/who-we-are/contact-us/

+81-6-6204-2111

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completed

Feb. 07, 2015

Interventional

multicenter, randomized, double-blind, placebo-controlled, parallel-group

treatment purpose

3

-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

-The participant has unstable systemic disease.
-The participant has Mini-Mental State Examination (MMSE) score of <= 24.
-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 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 received neurosurgical intervention for Parkinson's disease (e.g., pallidotomy, thalamotomy, deep brain stimulation).
-The participant has received transcranial magnetic stimulation within 6 months.
-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
-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.

Both

Parkinson's Disease

investigational material(s)
Generic name etc : TVP-1012
INN of investigational material : -
Therapeutic category code : 116 Antiperkinsonism agents
Dosage and Administration for Investigational material : TVP-1012 (1 mg/day) once daily orally, before or after breakfast

control material(s)
Generic name etc : TVP-1012 Placebo
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : TVP-1012 (1 mg/day) once daily orally, before or after breakfast

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.

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

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Jan. 15, 2015