A Phase 2/3 interventional study of TEV-50717 and Placebo in Tourette Syndrome, sponsored by Teva Branded Pharmaceutical Products R&D, Inc.. Completed at 42 sites in 6 countries. Open to participants aged 6 Years to 16 Years. Per ClinicalTrials.gov, last updated 2021-11-09.
Sponsored by Teva Branded Pharmaceutical Products R&D, Inc. · Phase 2/3, Interventional, and Treatment
This is a study to evaluate the efficacy and safety of deutetrabenazine (TEV-50717) tablets for the reduction of motor and phonic tics associated with TS in children and adolescents 6 through 16 years of age.
Women/girls of childbearing potential whose male partners are of childbearing potential must use contraception for the duration of the study.
Exclusion Criteria:
Participant is pregnant or breastfeeding.
TEV-50717 tablets twice daily (BID) up to 48 milligrams (mg)/day orally for a total of 12 weeks
Drug: TEV-50717 · Drug: Placebo
Placebo matched to TEV-50717 BID for a total of 12 weeks
Drug: Placebo
6, 9, 12, 15, and 18 mg oral tablets
Also known as: Deutetrabenazine
Placebo matched to TEV-50717 tablets will be taken BID for 12 weeks.
Change From Baseline in the TTS of the YGTSS at Week 12
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.
Time frame: Baseline, Week 12
Change From Baseline in the Tourette Syndrome-Clinical Global Impression (TS-CGI) Score at Week 12
The TS-CGI scale is a 7-point Likert scale that allows the clinician to use all available information to assess the impact of tics on the participant's quality of life. The TS-CGI is rated as follows: 1 (normal or no tics at all), 2 (borderline), 3 (mild), 4 (moderate), 5 (marked), 6 (severe), and 7 (extreme, incapacitating tics). Lower scores indicate better quality of life. LS mean and SE was calculated using 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.
Time frame: Baseline, Week 12
Change From Baseline in the Tourette Syndrome-Patient Global Impression of Impact (TS-PGII) Score at Week 12
The TS-PGII is a single-item questionnaire that asks the participant to assess the degree of impact due to current tics (How much do your current tics disrupt things in your life?). The TS-PGII uses a 5-point scale, ranging from not at all (1) to very much (5), to assess overall response to therapy.
Time frame: Baseline, Week 12
Change From Baseline in the Child and Adolescent Gilles de la Tourette Syndrome - Quality of Life (C&A-GTS-QOL) Activities of Daily Living (ADL) Subscale Score at Week 12
C\&A-GTS-QOL is a 27-item questionnaire that asks participant to assess the extent to which their quality of life is impacted by their symptoms. C\&A-GTS-QOL contains 6 subscales (cognitive, coprophenomena, psychological, physical, obsessive-compulsive, and ADL) and uses a 5-point Likert scale ranging from no problem to extreme problem. Following 3 questions from 27-item questionnaire were assessed in ADL C\&A-GTS-QOL subscale: Question 2 (Had difficulty with school or sport activities?), 24 (Felt you needed more help or support from other people?), and 26 (Had difficulty going out with other people?). Total score of ADL subscale ranged from 0 (no problem) to 12 (extreme problem). Lower score indicated better quality of life. LS mean and SE was calculated using MMRM with treatment group, week (5 levels: weeks 2, 4, 6, 9, and 12), and treatment group by week interaction as fixed effects; and baseline TTS, region, and age group at baseline (2 levels: 6-11 years, 12-16 years) as covariates.
Time frame: Baseline, Week 12
Percentage of Participants With Adverse Events
An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Relationship of AE to treatment was determined by the Investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent the previously listed serious outcomes. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time frame: Baseline (Day 1) to follow-up (Week 14)
| Milestone | TEV-50717 | Placebo |
|---|---|---|
| Started | 59 | 60 |
| Safety analysis set | 58 | 59 |
| Modified itt (mitt) analysis set | 58 | 59 |
| Completed | 54 | 56 |
| Not completed | 5 | 4 |
| Withdrew: Adverse event | 1 | 1 |
| Withdrew: Protocol violation | 0 | 1 |
| Withdrew: Withdrawal by subject | 3 | 2 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Milestone | TEV-50717 | Placebo |
|---|---|---|
| Started | 54 | 56 |
| Completed | 51 | 56 |
| Not completed | 3 | 0 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Withdrawal by subject | 2 | 0 |
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.
| units on a scale | TEV-50717 | Placebo |
|---|---|---|
| Change From Baseline in the TTS of the YGTSS at Week 12 | -9.1 ± 1.28 | -8.4 ± 1.25 |
The TS-CGI scale is a 7-point Likert scale that allows the clinician to use all available information to assess the impact of tics on the participant's quality of life. The TS-CGI is rated as follows: 1 (normal or no tics at all), 2 (borderline), 3 (mild), 4 (moderate), 5 (marked), 6 (severe), and 7 (extreme, incapacitating tics). Lower scores indicate better quality of life. LS mean and SE was calculated using 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.
| units on a scale | TEV-50717 | Placebo |
|---|---|---|
| Change From Baseline in the Tourette Syndrome-Clinical Global Impression (TS-CGI) Score at Week 12 | -0.7 ± 0.13 | -0.7 ± 0.12 |
The TS-PGII is a single-item questionnaire that asks the participant to assess the degree of impact due to current tics (How much do your current tics disrupt things in your life?). The TS-PGII uses a 5-point scale, ranging from not at all (1) to very much (5), to assess overall response to therapy.
| units on a scale | TEV-50717 | Placebo |
|---|---|---|
| Change From Baseline in the Tourette Syndrome-Patient Global Impression of Impact (TS-PGII) Score at Week 12 | -0.7 ± 0.18 | -0.4 ± 0.14 |
C\&A-GTS-QOL is a 27-item questionnaire that asks participant to assess the extent to which their quality of life is impacted by their symptoms. C\&A-GTS-QOL contains 6 subscales (cognitive, coprophenomena, psychological, physical, obsessive-compulsive, and ADL) and uses a 5-point Likert scale ranging from no problem to extreme problem. Following 3 questions from 27-item questionnaire were assessed in ADL C\&A-GTS-QOL subscale: Question 2 (Had difficulty with school or sport activities?), 24 (Felt you needed more help or support from other people?), and 26 (Had difficulty going out with other people?). Total score of ADL subscale ranged from 0 (no problem) to 12 (extreme problem). Lower score indicated better quality of life. LS mean and SE was calculated using MMRM with treatment group, week (5 levels: weeks 2, 4, 6, 9, and 12), and treatment group by week interaction as fixed effects; and baseline TTS, region, and age group at baseline (2 levels: 6-11 years, 12-16 years) as covariates.
| units on a scale | TEV-50717 | Placebo |
|---|---|---|
| Change From Baseline in the Child and Adolescent Gilles de la Tourette Syndrome - Quality of Life (C&A-GTS-QOL) Activities of Daily Living (ADL) Subscale Score at Week 12 | -9.9 ± 2.37 | -8.8 ± 2.27 |
An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Relationship of AE to treatment was determined by the Investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent the previously listed serious outcomes. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
| percentage of participants | TEV-50717 | Placebo |
|---|---|---|
| Any AEs | 65.5 | 55.9 |
| Treatment-related AEs | 50.0 | 20.3 |
| Serious AEs | 0 | 0 |
| AEs leading to discontinuation | 1.7 | 1.7 |
Collected over Baseline (Day 1) to follow-up (Week 14). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TEV-50717 | 0/58 (0%) | 0/58 (0%) | 22/58 (37.9%) |
| Placebo | 0/59 (0%) | 0/59 (0%) | 23/59 (39%) |
| Event | TEV-50717 | Placebo |
|---|---|---|
| FatigueGeneral disorders | 7/58 | 3/59 |
| Weight increasedInvestigations | 7/58 | 1/59 |
| Upper respiratory tract infectionInfections and infestations | 0/58 | 7/59 |
| HeadacheNervous system disorders | 6/58 | 6/59 |
| SomnolenceNervous system disorders | 5/58 | 1/59 |
| NauseaGastrointestinal disorders | 4/58 | 5/59 |
| DiarrhoeaGastrointestinal disorders | 4/58 | 1/59 |
| EnuresisPsychiatric disorders | 4/58 | 0/59 |
| VomitingGastrointestinal disorders | 3/58 | 3/59 |
| PyrexiaGeneral disorders | 3/58 | 2/59 |
ITT analysis set included all randomized participants.
| Age, Continuous(years) | TEV-50717 | Placebo | Total |
|---|---|---|---|
| Mean | 11.5 ± 2.52 | 11.5 ± 2.59 | 11.5 ± 2.54 |
| Sex: Female, Male(Participants) | TEV-50717 | Placebo | Total |
|---|---|---|---|
| Female | 6 | 9 | 15 |
| Male | 53 | 51 | 104 |
| Ethnicity (NIH/OMB)(Participants) | TEV-50717 | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 8 | 13 |
| Not Hispanic or Latino | 51 | 50 | 101 |
| Unknown or Not Reported | 3 | 2 | 5 |
| Race/Ethnicity, Customized(Participants) | TEV-50717 | Placebo | Total |
|---|---|---|---|
| White | 49 | 53 | 102 |
| Black | 3 | 3 | 6 |
| Asian | 1 | 1 | 2 |
| Native American | 1 | 0 | 1 |
| Multiple | 3 | 1 | 4 |
| Other | 2 | 2 | 4 |
| Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS)(units on a scale) | TEV-50717 | Placebo | Total |
|---|---|---|---|
| Mean | 31.7 ± 5.81 | 33.0 ± 5.96 | 32.3 ± 5.89 |
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Teva Branded Pharmaceutical Products R&D, Inc.