Overview

This trial has been completed.

Condition parkinson's disease
Treatment tvp-1012 1mg with levodopa
Phase phase 3
Sponsor Takeda
Start date February 2015
End date September 2016
Trial size 222 participants
Trial identifier NCT02337764, JapicCTI-152762, TVP-1012/OCT-002, U1111-1165-1500

Summary

The purpose of this study is to evaluate long-term safety of TVP-1012 (1 mg/day) with levodopa in Japanese participants with Parkinson's disease.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
TVP-1012 (1 mg/day) once daily orally, either before or after breakfast.
tvp-1012 1mg with levodopa
TVP-1012 1mg Tablets with levodopa, A levodopa combination drug will be concomitantly administered in principle without change in the dose regimen throughout the study period from the start of the screening period.

Primary Outcomes

Measure
Percentage of participants who experience at least one treatment emergent adverse event (TEAE)
time frame: Up to Week 54

Secondary Outcomes

Measure
Number of Participants With Markedly Abnormal Laboratory Values
time frame: Up to 54 Weeks
Clinically Significant Change from Baseline in Vital Signs
time frame: Baseline and Up to 54 Weeks
Significant Change from Baseline in Electrocardiograms
time frame: Baseline and Up to 54 Weeks
Significant Change from Baseline in Body Weight
time frame: Baseline and Up to 54 Weeks
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II total score
time frame: Up to 54 Weeks
MDS-UPDRS Part III total score
time frame: Up to 54 Weeks
Mean daily off-time
time frame: Up to 54 Weeks

Eligibility Criteria

Male or female participants from 30 years up to 79 years old.

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: - 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 <= 24. psychiatric disease. - The participant has a history of clinically significant hypertension or other reactions associated with ingestion of tyramine-rich food. - 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 selegiline, pethidine, tramadol, reserpine or methyldopa within 90 days. - The participant has received levodopa monotherapy, 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 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 during.

Additional Information

Official title 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
Description This is a multicenter, open-label, long-term, phase 3 study to evaluate the safety and efficacy of long-term administration of TVP-1012 at 1 mg with levodopa in Japanese participants with Parkinson's disease. The study period will consist of a 2-week screening period and a subsequent 52-week treatment period. Participants fulfilling the inclusion criteria and do not meet any of the exclusion criteria at the start of the screening period (Week -2; Visit1) and also at the end of the screening period (Week 0; Visit 2) will be enrolled in the study, and will receive 1 mg of TVP-1012 once daily for 52 weeks, in an unblinded manner, from the day after Visit 2.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Takeda.