Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02337751 | A Phase 3, Long-term, Extension Study of TVP-1012 (1 mg) in Early Parkinson's Disease Participants | PHASE3 | COMPLETED | 198 | — | — | Jul 10, 2015 | Mar 14, 2017 | Mar 2, 2022 | 56 | Japan |
| NCT02337725 | A Phase 3 Study of TVP-1012 (1 mg) in Early Parkinson's Disease Patients | PHASE3 | COMPLETED | 244 | — | — | Feb 7, 2015 | Sep 15, 2016 | Mar 2, 2022 | 55 | Japan |
| NCT02337764 | A Long-term, Phase 3 Study of TVP-1012 (1 mg) in Levodopa Treated Parkinson's Disease Participants | PHASE3 | COMPLETED | 222 | — | — | Feb 3, 2015 | Sep 29, 2016 | Mar 2, 2022 | 24 | Japan |
| NCT02337738 | A Phase 2/3 Study of TVP-1012 at 0.5 mg or 1 mg in Levodopa Treated Parkinson's Disease Participants | PHASE2 | COMPLETED | 404 | — | — | Jan 27, 2015 | Sep 17, 2016 | Mar 2, 2022 | 57 | Japan |
Reported data was the number collected from the first dose of TVP-1012 to the end of study (up to 52 weeks). Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).
Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (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+III Total Score was 0-188, with higher scores reflecting greater severity.
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.
| Arm | Type | Description |
|---|---|---|
| TVP-1012 1mg Group | EXPERIMENTAL | TVP-1012 (1 mg/day) once daily, either before or after breakfast. |
| TVP-1012 1 mg | EXPERIMENTAL | For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of TVP-1012 1 mg orally, once daily before or after breakfast. |
| Placebo | PLACEBO_COMPARATOR | For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of placebo orally, once daily before or after breakfast. |
| TVP-1012 1mg | EXPERIMENTAL | TVP-1012 1 mg once daily orally, either before or after breakfast, concomitantly with levodopa tablet for 52 weeks as treatment period after 2 weeks of run-in period. |
| TVP-1012 0.5mg | EXPERIMENTAL | TVP-1012 0.5 mg once daily orally, before or after breakfast, concomitantly with levodopa tablet for 26 weeks as treatment period after 2 weeks of run-in period. |
| Name | Type | Description |
|---|---|---|
| TVP-1012 1mg | DRUG | TVP-1012 1mg Tablets |
| TVP-1012 | DRUG | TVP-1012 1mg Tablets |
| Placebo | DRUG | Placebo tablets |
| TVP-1012 0.5mg | DRUG | TVP-1012 0.5mg Tablets |
Inclusion Criteria: * The participant has completed the preceding study. * The participant has shown no safety issues during the study treatment in the preceding study, in the opinion of the investigator or subinvestigator. Exclusion Criteria: * The participant has undergone blood collection of \...