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Tourette SyndromePhase 2/3ARTISTS1NCT03452943

Alternatives for Reducing Tics in Tourette Syndrome (TS): A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents

A Phase 2/3 study testing TEV-50717 in people with Tourette Syndrome, run by Teva Branded Pharmaceutical Products R&D, Inc. at 42 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 6 to 16 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
119 participants
Where
42 sitesin 6 countries
Study dates
5 Feb 2018to 12 Nov 2019
Phase
Phase 2/3
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 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Participant is 6 to 16 years of age, inclusive.
  • Participant weighs at least 44 pounds (20 kilograms [kg]).
  • The participant's active tics are causing distress or impairment.
  • Participant is able to swallow study medication whole.
  • Participant 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

  • Participant has a neurologic disorder other than TS that could obscure the evaluation of tics.
  • Participant has a confirmed diagnosis of bipolar disorder, schizophrenia, or another psychotic disorder.
  • Participant has clinically significant depression at screening or baseline.
  • Participant has a history of suicidal intent or related behaviors within 2 years of screening.
  • Participant has a history of a previous actual, interrupted, or aborted suicide attempt.
  • Participant has a first-degree relative who has completed suicide.
Show all 10Show fewer
  • Participant has received comprehensive behavioral intervention for tics (CBIT) for TS or cognitive behavioral therapy (CBT) for obsessive-compulsive disorder (OCD) within 4 weeks of screening.
  • Participant has an unstable or serious medical illness at screening or baseline.
  • Participant is pregnant or breastfeeding.
  • Additional criteria apply, please contact the investigator for more information.

Trial locations and contacts

42 sites in 6 countries.

42 sites in 6 countries

United States27 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 046-0113

    Dallas, Texas, 75243

  • Teva Investigational Site 046-0104

    Dothan, Alabama, 36303

  • Teva Investigational Site 046-0108

    Houston, Texas, 77030

  • Teva Investigational Site 046-0103

    Houston, Texas, 77090

  • Teva Investigational Site 046-0134

    Lincoln, Nebraska, 68526-9467

  • Teva Investigational Site 046-0132

    Miami, Florida, 33155

  • Teva Investigational Site 046-0133

    Naperville, Illinois, 60563

  • Teva Investigational Site 046-0124

    New York, New York, 10029

  • 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 046-0118

    Petersburg, Virginia, 23805

  • Teva Investigational Site 046-0125

    Raleigh, North Carolina, 27607

  • Teva Investigational Site 046-0102

    Rochester, New York, 14618

  • Teva Investigational Site 046-0112

    Rochester, New York, 14642

  • 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 046-0130

    Santa Ana, California, 92705

  • Teva Investigational Site 046-0114

    St. Petersburg, Florida, 33701

  • Teva Investigational Site 046-0117

    Sun City, Arizona, 85351

  • Teva Investigational Site 046-0109

    Voorhees Township, New Jersey, 08043

Other trials in United States

Spain5 sites

  • Teva Investigational Site 046-0604

    Barcelona, 08041

  • 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

Other trials in Spain

Russia3 sites

  • Teva Investigational Site 046-0702

    Stavropol, 355038

  • Teva Investigational Site 046-0704

    Tomsk, 634050

  • Teva Investigational Site 046-0703

    Voronezh, 394024

Other trials in Russia

Serbia3 sites

  • Teva Investigational Site 046-1702

    Belgrade, 11000

  • Teva Investigational Site 046-1703

    Belgrade, 11000

  • Teva Investigational Site 046-1701

    Novi Sad, 21000

Other trials in Serbia

Canada2 sites

  • Teva Investigational Site 046-0201

    Ajax, Ontario, L1Z0M1

  • Teva Investigational Site 046-0202

    Ottawa, Ontario, K2G 1W2

Other trials in Canada

Denmark2 sites

  • Teva Investigational Site 046-0302

    Herlev, 2730

  • Teva Investigational Site 046-0301

    Odense, 5000

Other trials in Denmark

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Study of TEV-50717 (Deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents

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.

Being tested
TEV-50717, Placebo
Keywords
Tourette Syndrome, 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

    6, 9, 12, 15, and 18 mg oral tablets

  • PlaceboDrug

    Placebo matched to TEV-50717 tablets will be taken BID for 12 weeks.

Study groups in NCT03452943
Study groupRoleWhat they receive
TEV-50717ExperimentalTEV-50717 tablets twice daily (BID) up to 48 milligrams (mg)/day orally for a total of 12 weeks
Receives: Drug: TEV-50717; Drug: Placebo
PlaceboPlacebo comparatorPlacebo matched to TEV-50717 BID for a total of 12 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, Week 12

Secondary outcomes (4)

  1. 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.

    Measured: Baseline, Week 12

  2. 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.

    Measured: Baseline, Week 12

  3. 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.

    Measured: Baseline, Week 12

  4. 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.

    Measured: Baseline (Day 1) to follow-up (Week 14)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2018
  2. Study start5 Feb 2018
  3. Primary completion12 Nov 2019
  4. Study completion12 Nov 2019

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
119 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03452943
Sponsor's protocol ID
TV50717-CNS-30046
Other IDs
2016-000622-19, 2016
Acronym
ARTISTS1
Status last verified
Nov 2021
First submitted
26 Feb 2018
Last updated
9 Nov 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Jankovic J, Coffey B, Claassen DO, Jimenez-Shahed J, Gertz BJ, Garofalo EA, Stamler DA, Wieman M, Savola JM, Gordon MF, Alexander J, Barkay H, Harary E. Safety and Efficacy of Flexible-Dose Deutetrabenazine in Children and Adolescents With Tourette Syndrome: A Randomized Clinical Trial. JAMA Netw Open. 2021 Oct 1;4(10):e2128204. doi: 10.1001/jamanetworkopen.2021.28204.

    PubMed 34609495

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing TEV-50717 in people with Tourette Syndrome, run by Teva Branded Pharmaceutical Products R&D, Inc. at 42 sites in 6 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 7 inclusion and 10 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: finished, 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 42 sites in United States, Spain, Russia, Serbia, Canada and 1 more country. 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 4 Jun 2020). 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?

Change From Baseline in the TTS of the YGTSS at Week 12 (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03452943, which also lists 1 linked publication.

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.

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