The purpose of this study is to evaluate the efficacy and safety of TVP-1012 (0.5 mg or 1 mg/day) as an add-on to levodopa in Japanese participants with Parkinson's disease with wearing-off phenomenon.
This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, phase 2/3 study to evaluate the efficacy and safety of TVP-1012 as an add-on to levodopa in Japanese participants with Parkinson's disease with wearing-off phenomenon. The study period consisted of a 28-week trial period. The participants who fulfilled the inclusion criteria and did not meeting any of the exclusion criteria were enrolled, and randomized in a 1:1:1 ratio to the 0.5 mg of TVP-1012, the 1 mg of TVP-1012, or the placebo group. In each treatment group, participants received 0.5 mg of TVP-1012, 1 mg of TVP-1012, or placebo once daily in a double-blinded manner.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
404
TVP-1012 1mg Tablets
TVP-1012 0.5mg Tablets
Placebo Tablets
Change From Baseline in Mean Daily OFF-time During Treatment Period
Reported change from baseline during treatment period which was calculated as follows: Mean for a total of 21 days, consisting of three separate 7-day periods preceding the visits at Week 6, 14 and 26 of the treatment period - Mean for the 7 days preceding the visit at the end of the run-in period. Off-time refers to times when levodopa is not working well, causing worsening symptoms.
Time frame: From Baseline to Week 26
Change From Baseline to Week 26 (LOCF) in Mean Daily OFF-time
Time frame: Baseline and Week 26 (LOCF)
Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Total Score
MDS-UPDRS retains the four-scale structure with a reorganization of the various subscale; (Part I; 13 items) non-motor experiences of daily living, (Part II; 13) motor experiences of daily living, (Part III; 34) motor examination, and (Part IV; 6) motor complications. Each items had 0-4 ratings, where 0 (normal) to 4 (severe) and score for each was summed to calculate the total scores. The scale range for Part II Total Score was 0-52, with higher scores reflecting greater severity.
Time frame: Baseline and Week 26 (LOCF)
Change From Baseline in MDS-UPDRS Part III Total Score
MDS-UPDRS retains the four-scale structure with a reorganization of the various subscale; (Part I; 13 items) non-motor experiences of daily living, (Part II; 13) motor experiences of daily living, (Part III; 34) motor examination, and (Part IV; 6) motor complications. Each items had 0-4 ratings, where 0 (normal) to 4 (severe) and score for each was summed to calculate the total scores. The scale range for Part III Total Score was 0-136, with higher scores reflecting greater severity.
Time frame: Baseline and Week 26 (LOCF)
Change From Baseline in Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Score
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Nagoya, Aichi-ken, Japan
Unnamed facility
Matsuyama, Ehime, Japan
Unnamed facility
Touon, Ehime, Japan
Unnamed facility
Kitakyushu, Fukuoka, Japan
Unnamed facility
Onoshiro, Fukuoka, Japan
Unnamed facility
Aizu-Wakamatsu, Fukushima, Japan
Unnamed facility
Fujioka, Gunma, Japan
Unnamed facility
Asahikawa, Hokkaido, Japan
Unnamed facility
Iwamizawa, Hokkaido, Japan
Unnamed facility
Sapporo, Hokkaido, Japan
...and 47 more locations
PDQ-39 is a self-administered questionnaire. PDQ-39 comprises of 39 questions, relating to eight key areas (Mobility, Activities of Daily Living, Emotional Well-being, Stigma, Social Support, Cognitions, Communication, and Bodily Discomfort) of health and daily activities, including both Motor and Non-motor symptoms. It is scored on a scale of zero to 100, with lower scores indicating better health and high scores more severe symptoms.
Time frame: Baseline and Week 26 (LOCF)
Change From Baseline in Parkinson's Disease Questionnaire-39 (PDQ-39) Each Domain Score
PDQ-39 is a self-administered questionnaire. PDQ-39 comprises of 39 questions, relating to eight key areas (Mobility, Activities of Daily Living, Emotional Well-being, Stigma, Social Support, Cognitions, Communication, and Bodily Discomfort) of health and daily activities, including both Motor and Non-motor symptoms. It is scored on a scale of zero to 100, with lower scores indicating better health and high scores more severe symptoms.
Time frame: Baseline and Week 26 (LOCF)
Number of Participants Who Experience at Least One Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Up to Week 26
Number of Participants With Markedly Abnormal Vital Signs Values
Time frame: Up to Week 26
Number of Participants With TEAE Related to Body Weight (Weight Decreased)
Time frame: Up to Week 26
Number of Participants With TEAE Related to Electrocardiograms (ECG) (Sinus Bradycardia)
Time frame: Up to Week 26
Number of Participants With TEAE Related to Clinical Laboratory Tests
Time frame: Up to Week 26