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. (part of Teva Pharmaceutical Industries, Ltd.) · Phase 2/3, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 139 studies in Tourette Syndrome with a site in United States — 20 open to participants now, 24 under way, 1 of them phase 3. Tourette Syndrome · United States.
Among the 139 studies in Tourette Syndrome with a site in United States, this one is the 25th largest by enrollment of the 105 interventional ones that give a count, is one of 12 that started in 2018, is one of 2 in phase 2/3, and was the 83rd registered.
240 studies on the registry are indexed under Tourette Syndrome; 40 are open to participants now.
Browse Tourette Syndrome studies →20 of the 139 studies in Tourette Syndrome with a site in United States are open now. Recruiting first, the newest first:
University of Minnesota · Sites in United States
Ages 12–17
University of Minnesota · Sites in United States
Ages 12–21
University of Utah · Sites in United States
Ages 8–17
Vanderbilt University Medical Center · Sites in United States
Ages 11–17 · Healthy volunteers
Boston Children's Hospital · Sites in United States
Ages 0–18
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 33 Tourette Syndrome studies recruiting now, 9 (27%) set no upper age limit and 22 (67%) stop at 75 or younger; 20 take children under 18; 9 take healthy volunteers.
This study: 6 Years to 16 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
139 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 11 · Phase 2 30 · Phase 3 12 · Phase 4 8
First in 1988; this study’s year is marked. 12 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 119 is above the median of 36 across 183 interventional studies indexed under Tourette Syndrome.
Median enrollment 33 across the 105 interventional studies, 90 across the 33 observational. Of the 106 that completed or were terminated, 45 (42%) have results posted.
This tab as a report to print or save as PDF → With an account.
34 of 139 have an industry lead sponsor. The 10 most frequent:
This study is registered under Teva Branded Pharmaceutical Products R&D, Inc., one of the names counted as Teva Pharmaceutical Industries, Ltd.. Under that name alone:
Teva Branded Pharmaceutical Products R&D, Inc. is the lead sponsor of 206 studies on the registry; none are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 47 (96%) have results posted.
Teva Pharmaceutical Industries, Ltd. has 4 studies filed under Tourette Syndrome — fewer than ten, so there is no comparison to draw.
6 of the studies in Tourette Syndrome with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05558566Yale UniversityNeurofeedback From the Supplementary Motor Area for Tourette Syndrome | 2026-12-20 |
| NCT01075672Massachusetts General HospitalOutcomes of Cognitive Behavioral Therapy (CBT) Interventions Provided by Unlicensed Professionals | 2027-01 |
| NCT03914664Vanderbilt University Medical CenterNeural Correlates of Sensory Phenomena in Tourette Syndrome | 2027-02-28 |
| NCT04851678Vanderbilt University Medical CenterLongitudinal Impact of Stressors in Adults With Tourette Syndrome | 2027-03-01 |
| NCT05126888Neurothera Labs Inc.SCI-110 in the Treatment of Tourette Syndrome | 2027-10 |
Add all 6 to your calendar (.ics) → With an account.
Among the 139 studies in Tourette Syndrome with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Women/girls of whose male partners are of childbearing potential must use for the duration of the study.
Exclusion Criteria:
Participant is pregnant or breastfeeding.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Feb 2018 to primary completion in Nov 2019, 21 months.
Results were first posted in Jun 2020, 6 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Deutetrabenazine
Teva Branded Pharmaceutical Products R&D, Inc. →