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TEV-50717 · 3 trials · 2 indications
MD-CRS part II evaluates the severity of movement disorder in a scale of 0 to 4 in 7 body regions, all areas in which dyskinesia can be seen. All items were scored by the rater in the clinic and were centrally read based on video recording. In rating the movement disorder of body part, 0 refers to absence of a movement disorder and 4 refers to a situation where movement disorder is present during all of the tasks for the region examined and/or involves 3 or more of the other regions, making completion impossible. The 7 body regions are (i) eye and periorbital region, (ii) face, (iii) tongue and perioral region, (iv) neck, (v) trunk, (vi) upper limb, and (vii) lower limb. Total score was obtained by summing the individual items scores and ranges from 0 (absent of a movement disorder) to 28 (marked/prolonged movement disorder), with higher scores indicating more movement disorder. Least square (LS) mean and standard error (SE) was calculated using a mixed-model repeated-measures (MMRM).
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 | EXPERIMENTAL | administered as oral tablets at a starting dose of 6 mg once daily |
| Placebo | PLACEBO_COMPARATOR | Matching placebo |
| 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 |
| Name | Type | Description |
|---|---|---|
| TEV-50717 | DRUG | Dosage ranging from 6 mg to 48 mg. |
| Placebo | DRUG | Dosage ranging from 6 mg to 48 mg. |
Inclusion Criteria: * Participant is 6 through 18 years of age (inclusive) at baseline. * Participant weighs at least 26 pounds (12 kg) at baseline. * Participant has had CP symptoms since infancy (≤2 years) * Choreiform is the prevalent movement disorder as assessed by the EAB at screening. * Part...
TEV-50717 is an investigational small molecule being studied for the treatment of Tourette Syndrome and dyskinetic cerebral palsy. It is being developed by Teva Pharmaceutical Industries Limited (TEVA) and is currently in Phase 3 clinical development for these neurological conditions.
TEV-50717 is a small molecule, but its specific molecular target has not been disclosed in the available information. It is being studied for its effects on tics associated with Tourette Syndrome and dyskinesia in cerebral palsy, though the precise mechanism of action is not detailed.
TEV-50717 is being developed by Teva Pharmaceutical Industries Limited, a company traded on the stock exchange under the ticker TEVA. The drug is currently in Phase 3 clinical trials for Tourette Syndrome and dyskinetic cerebral palsy.
TEV-50717 is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials have been completed for both Tourette Syndrome and dyskinetic cerebral palsy, with the most advanced study being a Phase 3 trial.
TEV-50717 has completed two clinical trials for Tourette Syndrome: NCT03452943, a Phase 2 study in children and adolescents, and NCT03571256, a Phase 3 study. It also completed NCT03813238, a Phase 3 study for dyskinesia in cerebral palsy. All trials were randomized, double-blind, and placebo-controlled.
TEV-50717 is also known as deutetrabenazine. Clinical trial titles refer to it as TEV-50717 (Deutetrabenazine). It is being studied for the treatment of Tourette Syndrome and dyskinetic cerebral palsy in children and adolescents.