Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Deutetrabenazine
TEV-50717 · 4 trials · 3 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.
Proportion of study subjects able to titrate up to 48 mg/d (or up to 36 mg/d if receiving a strong CYP2D6 inhibitor) and able to complete the study at this dosage
| 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 |
| Intervention arm - Oral Deutetrabenazine | EXPERIMENTAL | This is the only arm for this trial. All subjects will receive oral Deutetrabanazine. |
| Name | Type | Description |
|---|---|---|
| TEV-50717 | DRUG | Dosage ranging from 6 mg to 48 mg. |
| Placebo | DRUG | Dosage ranging from 6 mg to 48 mg. |
| Deutetrabenazine 6 MG | DRUG | Increasing doses of Deutetrabenazine |
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 in children and adolescents, and for dyskinetic cerebral palsy in children and adolescents. It is a deuterated form of tetrabenazine, and it is being developed by Teva Pharmaceutical Industries Limited (TEVA).
TEV-50717 works by depleting monoamines such as dopamine in the central nervous system, which helps reduce the involuntary movements and tics associated with Tourette Syndrome and dyskinetic cerebral palsy. Its mechanism involves inhibiting the vesicular monoamine transporter type 2 (VMAT2), thereby decreasing dopamine signaling in the brain.
TEV-50717 is being developed by Teva Pharmaceutical Industries Limited, a global pharmaceutical company headquartered in Israel. Teva's stock is traded on the New York Stock Exchange under the ticker symbol TEVA.
TEV-50717 has completed Phase 3 clinical trials for Tourette Syndrome and dyskinetic cerebral palsy. However, it is not yet approved by the FDA and remains an investigational drug. The completed trials include a Phase 2 study and two Phase 3 studies, all of which have finished enrollment and data collection.
TEV-50717 has completed two clinical trials for Tourette Syndrome: NCT03452943 (Phase 2, 119 participants) and NCT03571256 (Phase 3, 158 participants). It also completed NCT03813238 (Phase 3, 63 participants) for dyskinetic cerebral palsy. All trials were randomized, double-blind, and placebo-controlled, enrolling children and adolescents aged 6 years and older.
Yes, TEV-50717 is also known as deutetrabenazine. It is a deuterated form of tetrabenazine, designed to have a longer half-life and potentially improved tolerability. The clinical trials for TEV-50717 in Tourette Syndrome and cerebral palsy used the name deutetrabenazine in their titles.