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 \...
TVP-1012 is an investigational small molecule being developed for the treatment of Parkinson's Disease. It is being studied in patients with early Parkinson's Disease and in levodopa-treated Parkinson's Disease participants. The drug is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
TVP-1012 is being developed by Takeda Pharmaceutical Company Limited, a global pharmaceutical company. Takeda's stock is listed on the New York Stock Exchange under the ticker symbol TAK. The company is conducting clinical trials of TVP-1012 in Japan for the treatment of Parkinson's Disease.
TVP-1012 is in Phase 3 clinical development for Parkinson's Disease. The drug has completed four clinical trials, including Phase 2 and Phase 3 studies. All trials have been completed, and the drug remains investigational, meaning it has not yet received regulatory approval for marketing.
TVP-1012 has been studied in four completed clinical trials in Japan. These include NCT02337725, a Phase 3 study in early Parkinson's Disease; NCT02337738, a Phase 2/3 study in levodopa-treated participants; NCT02337751, a Phase 3 long-term extension study; and NCT02337764, a long-term Phase 3 study in levodopa-treated participants.
TVP-1012 is the investigational name for the drug being developed by Takeda. No alternative names have been reported for this compound. It is a small molecule being studied specifically for Parkinson's Disease, and it is not known to be marketed under any other brand name.