Tourette SyndromePhase 3ARTISTSNCT03567291
Evaluation of Safety and Tolerability of Long-term TEV-50717 (Deutetrabenazine) for Treatment of Tourette Syndrome in Children and Adolescents
A Phase 3 study testing TEV-50717 in people with Tourette Syndrome, run by Teva Branded Pharmaceutical Products R&D, Inc. at 76 sites in 15 countries.
Trial summary
This is an otherwise open-label, single-arm study that includes a 2-week, double-blind, placebo controlled, randomized drug withdrawal period followed by a 3 week blinded maintenance or re-titration, and then a maintenance period. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Tourette Syndrome
- What is being tested?
- TEV-50717
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- 76 sitesin 15 countries
- Study dates
- 25 May 2018to 15 May 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient is younger than 18 years of age on day 1
- Patient weighs at least 44 pounds (20 kg)
- The patient's active tics are causing distress or impairment
- Patient is able to swallow study medication whole
- Patient is in good general health
- Women/girls of childbearing potential whose male partners are of childbearing potential must use contraception for the duration of the study -- Additional criteria apply, please contact the investigator for more information
Who cannot join
- Patient is 18 years of age or older.
- Patient has a neurologic disorder other than TS that could obscure the evaluation of tics.
- The patient's predominant movement disorder is stereotypy (coordinated movements that repeat continually and identically) associated with autism spectrum disorder.
- Patient has a confirmed diagnosis of bipolar disorder, schizophrenia, or another psychotic disorder.
- Patient has clinically significant depression at screening or day 1. Note: Patients receiving antidepressant therapy may be enrolled if on a stable dose for at least 6 weeks before screening.
- Patient has a history of suicidal intent or related behaviors within 2 years of screening
Show all 17Show fewer
- Patient has a history of a previous actual, interrupted, or aborted suicide attempt.
- Patient has a first-degree relative who has completed suicide.
- Patient has clinically significant obsessive-compulsive disorder (OCD) on day 1 that, in the opinion of the investigator, is the primary cause of impairment.
- Patient has received comprehensive behavioral intervention for tics for TS or cognitive behavioral therapy for OCD within 4 weeks of screening.
- Patient has received treatment with deep brain stimulation, transmagnetic stimulation, or transcranial direct current stimulation for reduction of tics within 4 weeks of the screening visit.
- Patient has an unstable or serious medical illness at screening or day 1
- Patients with a history of torsade de pointes, congenital long QT syndrome, bradyarrhythmias, or uncompensated heart failure.
- Patient has received a monoamine oxidase inhibitor within 14 days of the day 1 visit.
- Patient has participated in an investigational drug or device study (with the exception of Study SD-809-C-17, Study TV50717-CNS-30046, or Study TV50717-CNS-30060) and received IMP/intervention within 30 days or 5 drug half-lives of day 1, whichever is longer.
- The patient is a pregnant or lactating female, or plans to become pregnant during the study.
- Patient has a history of, or acknowledges, alcohol-related disorder in the previous 12 months -- Additional criteria apply, please contact the investigator for more information
Trial locations and contacts
76 sites in 15 countries.
76 sites in 15 countries
United States33 sites
Teva Investigational Site 046-0126
Anaheim, California, 92805
Teva Investigational Site 046-0116
Atlanta, Georgia, 30331
Teva Investigational Site 046-0128
Boston, Massachusetts, 02114
Teva Investigational Site 060-0170
Bridgeton, Missouri, 63044
Teva Investigational Site 060-0169
Charleston, South Carolina, 29414-5834
Teva Investigational Site 060-0155
Chicago, Illinois, 60612
Teva Investigational Site 060-0164
Chicago, Illinois, 60634
Teva Investigational Site 046-0113
Dallas, Texas, 75243
Teva Investigational Site 046-0104
Dothan, Alabama, 36303
Teva Investigational Site 060-0162
Everett, Washington, 98201-4077
Teva Investigational Site 060-0163
Fort Worth, Texas, 76104
Teva Investigational Site 060-0160
Gainesville, Florida, 32608
Teva Investigational Site 060-0166
Gulf Breeze, Florida, 32561-4458
Teva Investigational Site 046-0108
Houston, Texas, 77030
Teva Investigational Site 046-0134
Lincoln, Nebraska, 68526-9467
Teva Investigational Site 060-0161
Miami, Florida, 33136-2107
Teva Investigational Site 046-0133
Naperville, Illinois, 60563
Teva Investigational Site 060-0156
Nashville, Tennessee, 37232-2551
Teva Investigational Site 046-0124
New York, New York, 10029
Teva Investigational Site 060-0154
New York, New York, 10036
Teva Investigational Site 046-0106
Oklahoma City, Oklahoma, 73116
Teva Investigational Site 046-0105
Orem, Utah, 84058
Teva Investigational Site 046-0115
Orlando, Florida, 32803
Teva Investigational Site 060-0153
Orlando, Florida, 32819
Teva Investigational Site 046-0118
Petersburg, Virginia, 23805
Teva Investigational Site 046-0102
Rochester, New York, 14618
Teva Investigational Site 046-0107
Rogers, Arkansas, 72758
Teva Investigational Site 046-0101
Sacramento, California, 95815
Teva Investigational Site 046-0110
Saint Charles, Missouri, 63304
Teva Investigational Site 046-0120
San Antonio, Texas, 78249
Teva Investigational Site 046-0111
San Diego, California, 92108
Teva Investigational Site 046-0114
St. Petersburg, Florida, 33701
Teva Investigational Site 046-0109
Voorhees Township, New Jersey, 08043
Ukraine6 sites
Teva Investigational Site 060-2003
Dnipropetrovsk, 49101
Teva Investigational Site 060-2001
Kharkiv, 61068
Teva Investigational Site 060-2002
Kharkiv, 61153
Teva Investigational Site 060-2007
Kiev, 4080
Teva Investigational Site 060-2005
Kyiv, 4209
Teva Investigational Site 060-2006
Vinnytsia, 21005
Poland5 sites
Teva Investigational Site 060-1104
Gdansk, 80-542
Teva Investigational Site 060-1101
Katowice, 40-123
Teva Investigational Site 060-1105
Krakow, 31503
Teva Investigational Site 060-1102
Poznan, 60-693
Teva Investigational Site 060-1103
Warsaw, 02-793
Argentina4 sites
Teva Investigational Site 060-1407
Buenos Aires, C1023AAB
Teva Investigational Site 060-1402
Buenos Aires, C1425AHQ
Teva Investigational Site 060-1403
La Plata, 1900
Teva Investigational Site 060-1404
Mendoza, 5500
Mexico4 sites
Teva Investigational Site 060-1601
Culiacán, 80020
Teva Investigational Site 060-1603
León, 37000
Teva Investigational Site 060-1602
Monterrey, 64460
Teva Investigational Site 060-1604
Monterrey, 64610
Spain4 sites
Teva Investigational Site 046-0605
Madrid, 28009
Teva Investigational Site 046-0602
Madrid, 28922
Teva Investigational Site 046-0603
Málaga, 29620
Teva Investigational Site 046-0601
Seville, 41013
Italy3 sites
Teva Investigational Site 060-1005
Cagliari, 09121
Teva Investigational Site 060-1001
Catania, 95123
Teva Investigational Site 060-1003
Naples, 80131
Serbia3 sites
Teva Investigational Site 046-1702
Belgrade, 11000
Teva Investigational Site 046-1703
Belgrade, 11000
Teva Investigational Site 046-1701
Novi Sad, 21000
South Korea3 sites
Teva Investigational Site 060-1901
Seoul, 110-744
Teva Investigational Site 060-1903
Seoul, 138-736
Teva Investigational Site 060-1902
Seoul, 6351
Canada2 sites
Teva Investigational Site 046-0201
Ajax, Ontario, L1Z0M1
Teva Investigational Site 046-0202
Ottawa, Ontario, K2G 1W2
Colombia2 sites
Teva Investigational Site 060-1503
Bello, 051050
Teva Investigational Site 060-1504
Pereira, 660003
Denmark2 sites
Teva Investigational Site 046-0302
Herlev, 2730
Teva Investigational Site 046-0301
Odense, 5000
Hungary2 sites
Teva Investigational Site 060-0901
Budapest, 1021
Teva Investigational Site 060-0902
Szeged, 6725
Russia2 sites
Teva Investigational Site 046-0704
Tomsk, 634050
Teva Investigational Site 046-0703
Voronezh, 394024
About this study
Official title: An Open-Label, Long-Term Safety Study Including a Double-Blind, Placebo-Controlled, Randomized Withdrawal Period of TEV-50717 (Deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents
This is an otherwise open-label, single-arm study that includes a 2-week, double-blind, placebo controlled, randomized drug withdrawal period followed by a 3 week blinded maintenance or re-titration, and then a maintenance period. This study aims to evaluate the safety and efficacy of TEV-50717 tablets in patients with tics associated with TS who have previously completed participation in any of the parent studies.
Read the detailed description
This is an otherwise open-label, single-arm study (Part A) that includes a 2-week, double-blind, placebo controlled, randomized drug withdrawal period (Part B) followed by a 3 week blinded maintenance or re-titration (Part A resumed), and then a maintenance period. This study aims to evaluate the safety and efficacy of TEV-50717 tablets in patients with tics associated with TS who have previously completed participation in any of the parent studies (SD-809-C-17 [Phase 1b], TV50717-CNS 30046 [Phase 2/3], or TV50717-CNS 30060 [Phase 3]).
- Conditions
- Tourette Syndrome
- Being tested
- TEV-50717, Placebo
- Keywords
- adolescents, children
- Medical subject headings
- Tourette Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEV-50717Drug
Also called deutetrabenazine, SD-809
6, 9, and 12 mg oral tablets
PlaceboDrug
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| TEV-50717- Part A | Experimental | All patients will undergo TEV-50717 dose titration in this study. Patients will receive 6 mg of TEV-50717 with food on the evening of day 1. The titration scheme and maximum dose will be determined by body weight and cytochrome P450 2D6 (CYP2D6) impairment status from the parent study. Receives: Drug: TEV-50717 |
| TEV-50717- Part B RW | Experimental | TEV-50717 is administered during Part B Randomized Drug Withdrawal (RW) 2-week period. Receives: Drug: TEV-50717 |
| Placebo- Part B RW | Placebo comparator | Placebo is administered during Part B Randomized Drug Withdrawal (RW) 2-week period only. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting Treatment Emergent Adverse Events (AEs) for Parts A & B Combined
Adverse events were analyzed for all participants in Parts A \& B combined as one group for this outcome measure. 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. Incudes clinically significant changes such as changes in vital signs or lab values. 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.
Measured: Day 1 to Week 55
Number of Participants Reporting Treatment Emergent Adverse Events (AEs) in Part B (Period II)
Adverse events were analyzed for Part B for this outcome measure. 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. Incudes clinically significant changes such as changes in vital signs or lab values. 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.
Measured: Weeks 28 to 30
Change From Baseline in the Children's Depression Inventory Second Edition (CDI-2; Parent Version) Total Score
Parents were asked to rate their child's behaviors in past 2 weeks on a 4-point Likert scale from "not at all" to "much or most of the time." It contains 2 subscales (emotional problems and functional problem). Total score: sum of 2 subscales, ranging from 0 to 51, with higher score indicating more depression-related behaviors.
Measured: Baseline, Weeks 2, 4, 8, 15, 28, 34, 41, 54, 55
Change From Baseline in the Children's Depression Inventory Second Edition (CDI-2; Self-reported Version) Total Score
CDI-2 self-report: 28-item questionnaire assessing depressive symptoms in children 7 to 17 years of age with basic reading and comprehension skills. Children were asked to choose 1 of 3 statements that most closely aligns with their feelings in past 2 weeks. It contains 6 subscales (emotional problem, negative mood/physical symptoms, negative self-esteem, functional problems, ineffectiveness, interpersonal problems). Total score: sum of all subscales scores, ranging from 0 to 56, with higher score indicating greater depression severity.CDI-2 parent: 17-item questionnaire administered to parents to assess depression-related behaviors observed in their children.
Measured: Baseline, Weeks 2, 4, 8, 15, 28, 34, 41, 54, 55
Change From Randomized Withdrawal Baseline (Week 28) in the Children's Depression Inventory Second Edition (CDI-2; Parent Version) Total Score at Week 30
Parents were asked to rate their child's behaviors in past 2 weeks on a 4-point Likert scale from "not at all" to "much or most of the time." It contains 2 subscales (emotional problems and functional problem). Total score: sum of 2 subscales, ranging from 0 to 51, with higher score indicating more depression-related behaviors.
Measured: Week 28, Week 30
Change From Randomized Withdrawal Baseline (Week 28) in the Children's Depression Inventory Second Edition (CDI-2; Self-reported Version) Total Score at Week 30
CDI-2 self-report: 28-item questionnaire assessing depressive symptoms in children 7 to 17 years of age with basic reading and comprehension skills. Children were asked to choose 1 of 3 statements that most closely aligns with their feelings in past 2 weeks. It contains 6 subscales (emotional problem, negative mood/physical symptoms, negative self-esteem, functional problems, ineffectiveness, interpersonal problems). Total score: sum of all subscales scores, ranging from 0 to 56, with higher score indicating greater depression severity.CDI-2 parent: 17-item questionnaire administered to parents to assess depression-related behaviors observed in their children.
Measured: Week 28, Week 30
Number of Participants Reporting Any Suicidal Ideation or Suicidal Behavior According to the Columbia Suicide Severity Rating Scale (C-SSRS)
C-SSRS included responses for Suicidal Ideation or Suicidal Behavior in following 10 categories: 1 = Wish to be dead; 2 = Non-specific active suicidal thoughts; 3 = Active suicidal ideation with any methods (not plan) without intent to act; 4 = Active suicidal ideation with some intent to act, without specific plan; 5 = Active suicidal ideation with specific plan and intent; 6 = Preparatory acts or behavior; 7 = Aborted attempt; 8 = Interrupted attempt; 9 = Non-fatal suicide attempt; and 10 = Completed suicide. Number of participants with any suicidal ideation or suicidal behavior are reported. Any Suicidal ideation or Suicidal Behavior events reported as TEAEs along with all other reported TEAEs are included in the AE module.
Measured: Baseline, Weeks 2, 4, 8, 15, 28, 34, 41, 54, 55
Number of Participants Reporting Any Suicidal Ideation or Suicidal Behavior According to the Columbia Suicide Severity Rating Scale (C-SSRS) at Randomized Withdrawal Baseline Visit (Week 28) and Week 30
C-SSRS included responses for Suicidal Ideation or Suicidal Behavior in following 10 categories: 1 = Wish to be dead; 2 = Non-specific active suicidal thoughts; 3 = Active suicidal ideation with any methods (not plan) without intent to act; 4 = Active suicidal ideation with some intent to act, without specific plan; 5 = Active suicidal ideation with specific plan and intent; 6 = Preparatory acts or behavior; 7 = Aborted attempt; 8 = Interrupted attempt; 9 = Non-fatal suicide attempt; and 10 = Completed suicide. Number of participants with any suicidal ideation or suicidal behavior are reported. Any Suicidal ideation or Suicidal Behavior events reported as TEAEs along with all other reported TEAEs are included in the AE module.
Measured: Week 28, Week 30
Secondary outcomes (5)
Change From Baseline in the Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS)
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. Baseline is defined as the last measurement on or prior to the first dose of the open-label study medication.
Measured: Baseline, Weeks 8, 15, 28, 41, 54, and 55
Change From Baseline in the Tourette Syndrome-Clinical Global Impression (TS-CGI) Score
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. Baseline is defined as the last measurement on or prior to the first dose of the open-label study medication.
Measured: Baseline, Weeks 8, 15, 28, 41, 54, and 55
Change From Baseline in the Tourette Syndrome-Patient Global Impression of Impact (TS-PGII) Score
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. Baseline is defined as the last measurement on or prior to the first dose of the open-label study medication.
Measured: Baseline, Weeks 8, 15, 28, 41, 54, and 55
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
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. Baseline is defined as the last measurement on or prior to the first dose of the open-label study medication.
Measured: Baseline, Weeks 6, 28, 34, 54
Change From Randomized Withdrawal Baseline (Week 28) in the Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS) to Week 30
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. The model is an ANCOVA model that includes fixed effects for treatment group. The randomized withdrawal baseline TTS and age group at baseline (2 levels: 6-11 years, 12-18 years) are included as covariates.
Measured: Week 28, Week 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2018
- Study start25 May 2018
- Primary completion15 May 2020
- Study completion15 May 2020
Why it stopped: The parent trials did not meet the primary endpoints of reduction in motor and phonic tics.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nuvelution TS Pharma, Inc.
- Responsible party
- Sponsor
- Investigators
- Teva Medical Expert, MD, Study director, Teva Branded Pharmaceutical Products R&D, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03567291
- Sponsor's protocol ID
- TV50717-CNS-30047
- Other IDs
- 2016-000630-22, 2016
- Acronym
- ARTISTS
- Status last verified
- Nov 2021
- First submitted
- 12 Jun 2018
- Last updated
- 9 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Long-Term Safety Study Including a Double-Blind, Placebo-Controlled, Randomized Withdrawal Period of TEV-50717 (Deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents
- ClinicalTrials.gov ID
- NCT03567291
- Acronym / sponsor ID
- ARTISTS / TV50717-CNS-30047
- Conditions
- Tourette Syndrome
- Keywords
- adolescents, children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The parent trials did not meet the primary endpoints of reduction in motor and phonic tics.
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Nuvelution TS Pharma, Inc.
- Study start
- 25 May 2018 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 25 Jun 2018 (actual)
- Results
- Posted 23 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an otherwise open-label, single-arm study that includes a 2-week, double-blind, placebo controlled, randomized drug withdrawal period followed by a 3 week blinded maintenance or re-titration, and then a maintenance period. This study aims to evaluate the safety and efficacy of TEV-50717 tablets in patients with tics associated with TS who have previously completed participation in any of the parent studies.
Detailed description
This is an otherwise open-label, single-arm study (Part A) that includes a 2-week, double-blind, placebo controlled, randomized drug withdrawal period (Part B) followed by a 3 week blinded maintenance or re-titration (Part A resumed), and then a maintenance period. This study aims to evaluate the safety and efficacy of TEV-50717 tablets in patients with tics associated with TS who have previously completed participation in any of the parent studies (SD-809-C-17 [Phase 1b], TV50717-CNS 30046 [Phase 2/3], or TV50717-CNS 30060 [Phase 3]).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TEV-50717- Part A | Experimental | Drug: TEV-50717All patients will undergo TEV-50717 dose titration in this study. Patients will receive 6 mg of TEV-50717 with food on the evening of day 1. The titration scheme and maximum dose will be determined by body weight and cytochrome P450 2D6 (CYP2D6) impairment status from the parent study. |
| TEV-50717- Part B RW | Experimental | Drug: TEV-50717TEV-50717 is administered during Part B Randomized Drug Withdrawal (RW) 2-week period. |
| Placebo- Part B RW | Placebo comparator | Drug: PlaceboPlacebo is administered during Part B Randomized Drug Withdrawal (RW) 2-week period only. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Patient is younger than 18 years of age on day 1
- Patient weighs at least 44 pounds (20 kg)
- The patient's active tics are causing distress or impairment
- Patient is able to swallow study medication whole
- Patient is in good general health
Key exclusion criteria (17 listed)
- Patient is 18 years of age or older.
- Patient has a neurologic disorder other than TS that could obscure the evaluation of tics.
- The patient's predominant movement disorder is stereotypy (coordinated movements that repeat continually and identically) associated with autism spectrum disorder.
- Patient has a confirmed diagnosis of bipolar disorder, schizophrenia, or another psychotic disorder.
- Patient has clinically significant depression at screening or day 1. Note: Patients receiving antidepressant therapy may be enrolled if on a stable dose for at least 6 weeks before screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEV-50717Also: deutetrabenazine, SD-8096, 9, and 12 mg oral tablets | Drug | TEV-50717- Part A, TEV-50717- Part B RW |
| PlaceboPlacebo comparator | Drug | Placebo- Part B RW |
Primary outcome
Number of Participants Reporting Treatment Emergent Adverse Events (AEs) for Parts A & B Combined
Time frame: Day 1 to Week 55
Adverse events were analyzed for all participants in Parts A \& B combined as one group for this outcome measure. 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. Incudes clinically significant changes such as changes in vital signs or lab values. 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.
Number of Participants Reporting Treatment Emergent Adverse Events (AEs) in Part B (Period II)
Time frame: Weeks 28 to 30
Adverse events were analyzed for Part B for this outcome measure. 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. Incudes clinically significant changes such as changes in vital signs or lab values. 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.
Change From Baseline in the Children's Depression Inventory Second Edition (CDI-2; Parent Version) Total Score
Time frame: Baseline, Weeks 2, 4, 8, 15, 28, 34, 41, 54, 55
Parents were asked to rate their child's behaviors in past 2 weeks on a 4-point Likert scale from "not at all" to "much or most of the time." It contains 2 subscales (emotional problems and functional problem). Total score: sum of 2 subscales, ranging from 0 to 51, with higher score indicating more depression-related behaviors.
Change From Baseline in the Children's Depression Inventory Second Edition (CDI-2; Self-reported Version) Total Score
Time frame: Baseline, Weeks 2, 4, 8, 15, 28, 34, 41, 54, 55
CDI-2 self-report: 28-item questionnaire assessing depressive symptoms in children 7 to 17 years of age with basic reading and comprehension skills. Children were asked to choose 1 of 3 statements that most closely aligns with their feelings in past 2 weeks. It contains 6 subscales (emotional problem, negative mood/physical symptoms, negative self-esteem, functional problems, ineffectiveness, interpersonal problems). Total score: sum of all subscales scores, ranging from 0 to 56, with higher score indicating greater depression severity.CDI-2 parent: 17-item questionnaire administered to parents to assess depression-related behaviors observed in their children.
Change From Randomized Withdrawal Baseline (Week 28) in the Children's Depression Inventory Second Edition (CDI-2; Parent Version) Total Score at Week 30
Time frame: Week 28, Week 30
Parents were asked to rate their child's behaviors in past 2 weeks on a 4-point Likert scale from "not at all" to "much or most of the time." It contains 2 subscales (emotional problems and functional problem). Total score: sum of 2 subscales, ranging from 0 to 51, with higher score indicating more depression-related behaviors.
Change From Randomized Withdrawal Baseline (Week 28) in the Children's Depression Inventory Second Edition (CDI-2; Self-reported Version) Total Score at Week 30
Time frame: Week 28, Week 30
CDI-2 self-report: 28-item questionnaire assessing depressive symptoms in children 7 to 17 years of age with basic reading and comprehension skills. Children were asked to choose 1 of 3 statements that most closely aligns with their feelings in past 2 weeks. It contains 6 subscales (emotional problem, negative mood/physical symptoms, negative self-esteem, functional problems, ineffectiveness, interpersonal problems). Total score: sum of all subscales scores, ranging from 0 to 56, with higher score indicating greater depression severity.CDI-2 parent: 17-item questionnaire administered to parents to assess depression-related behaviors observed in their children.
Number of Participants Reporting Any Suicidal Ideation or Suicidal Behavior According to the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline, Weeks 2, 4, 8, 15, 28, 34, 41, 54, 55
C-SSRS included responses for Suicidal Ideation or Suicidal Behavior in following 10 categories: 1 = Wish to be dead; 2 = Non-specific active suicidal thoughts; 3 = Active suicidal ideation with any methods (not plan) without intent to act; 4 = Active suicidal ideation with some intent to act, without specific plan; 5 = Active suicidal ideation with specific plan and intent; 6 = Preparatory acts or behavior; 7 = Aborted attempt; 8 = Interrupted attempt; 9 = Non-fatal suicide attempt; and 10 = Completed suicide. Number of participants with any suicidal ideation or suicidal behavior are reported. Any Suicidal ideation or Suicidal Behavior events reported as TEAEs along with all other reported TEAEs are included in the AE module.
Number of Participants Reporting Any Suicidal Ideation or Suicidal Behavior According to the Columbia Suicide Severity Rating Scale (C-SSRS) at Randomized Withdrawal Baseline Visit (Week 28) and Week 30
Time frame: Week 28, Week 30
C-SSRS included responses for Suicidal Ideation or Suicidal Behavior in following 10 categories: 1 = Wish to be dead; 2 = Non-specific active suicidal thoughts; 3 = Active suicidal ideation with any methods (not plan) without intent to act; 4 = Active suicidal ideation with some intent to act, without specific plan; 5 = Active suicidal ideation with specific plan and intent; 6 = Preparatory acts or behavior; 7 = Aborted attempt; 8 = Interrupted attempt; 9 = Non-fatal suicide attempt; and 10 = Completed suicide. Number of participants with any suicidal ideation or suicidal behavior are reported. Any Suicidal ideation or Suicidal Behavior events reported as TEAEs along with all other reported TEAEs are included in the AE module.
5 secondary outcomes
Change From Baseline in the Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS)
Time frame: Baseline, Weeks 8, 15, 28, 41, 54, and 55
Change From Baseline in the Tourette Syndrome-Clinical Global Impression (TS-CGI) Score
Time frame: Baseline, Weeks 8, 15, 28, 41, 54, and 55
Change From Baseline in the Tourette Syndrome-Patient Global Impression of Impact (TS-PGII) Score
Time frame: Baseline, Weeks 8, 15, 28, 41, 54, and 55
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
Time frame: Baseline, Weeks 6, 28, 34, 54
Change From Randomized Withdrawal Baseline (Week 28) in the Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS) to Week 30
Time frame: Week 28, Week 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teva Medical Expert, MD study director
Teva Branded Pharmaceutical Products R&D, Inc.
76 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TEV-50717 in people with Tourette Syndrome, run by Teva Branded Pharmaceutical Products R&D, Inc. at 76 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 76 sites in United States, Ukraine, Poland, Argentina, Mexico and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Reporting Treatment Emergent Adverse Events (AEs) for Parts A & B Combined (time frame: Day 1 to Week 55). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.