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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03571256 | A Study to Test if TEV-50717 is Effective in Relieving Tics Associated With Tourette Syndrome (TS) | PHASE3 | COMPLETED | 158 | — | — | May 31, 2018 | Dec 9, 2019 | Nov 9, 2021 | 56 | United States, Argentina +8 |
| NCT03452943 | Alternatives for Reducing Tics in Tourette Syndrome (TS): A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents | PHASE2 | COMPLETED | 119 | — | — | Feb 5, 2018 | Nov 12, 2019 | Nov 9, 2021 | 42 | United States, Canada +4 |
YGTSS rating scale is a semi-structured clinician rating instrument that provides an evaluation of the number, frequency, intensity, complexity, and interference of motor and phonic tics. YGTSS is composed of 11 items: 5 items for motor tic severity, 5 items for vocal tic severity, and 1 item for impairment. Each item for motor tic severity and vocal is rated on a 6-point scale (0 for none to 5 to severe). MTSS is the sum of the 5 items for motor tic severity and VTSS is the sum of the 5 items for vocal tic severity. TTS is the sum of MTSS and VTSS, ranges from 0 (none/absent) to 50 (severe). Higher scores indicate greater severity/worse outcome. Least square (LS) mean and standard error (SE) was calculated using mixed-model repeated-measures (MMRM) with treatment group, week (3 levels: Weeks 2, 4, and 8), and the treatment group by week interaction as fixed effects; and baseline TTS, region, and age group at baseline (2 levels: 6 to 11 years, 12 to 16 years) as covariates.
YGTSS rating scale is a semi-structured clinician rating instrument that provides an evaluation of the number, frequency, intensity, complexity, and interference of motor and phonic tics. YGTSS is composed of 11 items: 5 items for motor tic severity, 5 items for vocal tic severity, and 1 item for impairment. Each item for motor tic severity and vocal is rated on a 6-point scale (0 for none to 5 to severe). MTSS is the sum of the 5 items for motor tic severity and VTSS is the sum of the 5 items for vocal tic severity. TTS is the sum of MTSS and VTSS, ranges from 0 (none/absent) to 50 (severe). Higher scores indicate greater severity/worse outcome. Least square (LS) mean and standard error (SE) was calculated using mixed-model repeated-measures (MMRM) with treatment group, week (5 levels: weeks 2, 4, 6, 9, and 12), and the treatment group by week interaction as fixed effects; and baseline TTS, region, and age group at baseline (2 levels: 6 to 11 years, 12 to 16 years) as covariates.
| Arm | Type | Description |
|---|---|---|
| TEV-50717 High-Dose | EXPERIMENTAL | TEV-50717 tablets twice daily (BID) up to 48 milligrams (mg)/day orally for a total of 8 weeks |
| TEV-50717 Low-Dose | EXPERIMENTAL | TEV-50717 tablets BID up to 36 mg/day orally for a total of 8 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo matched to TEV-50717 for a total of 8 weeks |
| TEV-50717 | EXPERIMENTAL | TEV-50717 tablets twice daily (BID) up to 48 milligrams (mg)/day orally for a total of 12 weeks |
| Name | Type | Description |
|---|---|---|
| TEV-50717 | DRUG | 6-, 9-, 12-, 15-, and 18 mg oral tablets |
| Placebo | DRUG | Placebo matched to TEV-50717 tablets will be taken BID. |
Inclusion Criteria: * Participant weighs at least 44 pounds (20 kg) at baseline. * Participant meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5™) diagnostic criteria for TS and, in the opinion of the investigator, participant, and parent/legal guardian, the part...