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.
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 consisted of a 2-week run-in period and a subsequent 52-week treatment period. Participants fulfilling the inclusion criteria and did not meet any of the exclusion criteria at the start of the run-in period (Week -2) and also at the end of the run-in period (Week 0) were enrolled in the study, and received 1 mg of TVP-1012 once daily for 52 weeks, in an unblinded manner, from the day after Week 0.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
222
TVP-1012 1mg Tablets
Unnamed facility
Nagoya, Aichi-ken, Japan
Unnamed facility
Matsuyama, Ehime, Japan
Unnamed facility
Fukuoka, Fukouka, Japan
Number of Participants Who Experience at Least One Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Up to Week 52
Number of Participants With TEAE Related to Clinical Laboratory Tests
Time frame: Up to Week 52
Number of Participants With Markedly Abnormal Vital Signs Values
Time frame: Up to Week 52
Number of Participants With TEAE Related to Electrocardiograms (ECG)
Time frame: Up to Week 52
Number of Participants With TEAE Related to Body Weight (Weight Decreased)
Time frame: Up to Week 52
Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Total Score
Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) retained the four-scale structure with a reorganization of the various subscales; (Part I) non-motor experiences of daily living (13 items), (Part II) motor experiences of daily living (13 items), (Part III) motor examination (33 scores based on 18 items), and (Part IV) motor complications (6 items). Each items had 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The scale range for Part II Total Score was 0-52, with higher scores reflecting greater severity.
Time frame: Baseline and Week 52 (LOCF)
Change From Baseline in MDS-UPDRS Part III Total Score
Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) retained the four-scale structure with a reorganization of the various subscales; (Part I) non-motor experiences of daily living (13 items), (Part II) motor experiences of daily living (13 items), (Part III) motor examination (33 scores based on 18 items), and (Part IV) motor complications (6 items). Each items had 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The scale range for Part III Total Score was 0-132, with higher scores reflecting greater severity.
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Unnamed facility
Kōriyama, Fukushima, Japan
Unnamed facility
Sapporo, Hokkaido, Japan
Unnamed facility
Himeji, Hyōgo, Japan
Unnamed facility
Kobe, Hyōgo, Japan
Unnamed facility
Sanda, Hyōgo, Japan
Unnamed facility
Tsuchiura, Ibaragi, Japan
Unnamed facility
Ichinoseki, Iwate, Japan
...and 14 more locations
Time frame: Baseline and Week 52 (LOCF)
Change From Baseline to Week 52 (LOCF) in Mean Daily OFF-time
Off-time refers to times when levodopa is not working well, causing worsening symptoms.
Time frame: Baseline and Week 52 (LOCF)