Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TVP-1012 · 4 trials · 1 indication
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 \...
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| Merck & Co., Inc. | MRK | 1 | EARLY_PHASE1 | MK-0947 |
TVP-1012 is an investigational small molecule being developed for the treatment of Parkinson's disease. It has been studied in both early Parkinson's disease and in patients already receiving levodopa. The clinical program includes four completed trials in Japan, with a total enrollment of 1,068 participants.
TVP-1012 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the clinical program evaluating the drug in Parkinson's disease.
TVP-1012 has completed Phase 3 clinical development. Four trials have been completed, including three Phase 3 studies and one Phase 2/3 study. All four trials are listed as completed, and there are currently no active trials for TVP-1012.
TVP-1012 has been evaluated in four completed clinical trials: NCT02337764, a Phase 3 long-term study in levodopa-treated Parkinson's disease; NCT02337751, a Phase 3 long-term extension study in early Parkinson's disease; NCT02337738, a Phase 2/3 study at 0.5 mg or 1 mg in levodopa-treated patients; and NCT02337725, a Phase 3 study in early Parkinson's disease.