Clinical trial NCT03452943: Alternatives for Reducing Tics in Tourette Syndrome (TS): A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents
Official title: A Randomized, Double-blind, Placebo-controlled Study of TEV-50717 (Deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Tourette Syndrome
Keywords: Tourette Syndrome
adolescents
children
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Nuvelution TS Pharma, Inc.
First posted: 2018-03-02
Enrollment: 119
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Change From Baseline in the TTS of the YGTSS at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in the Tourette Syndrome-Clinical Global Impression (TS-CGI) Score at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in the Tourette Syndrome-Patient Global Impression of Impact (TS-PGII) Score at Week 12
timeFrame: Baseline, Week 12
measure: 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
timeFrame: Baseline, Week 12
measure: Percentage of Participants With Adverse Events
timeFrame: Baseline (Day 1) to follow-up (Week 14)
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Teva Investigational Site 046-0104
state: Alabama
city: Sun City
country: United States
facility: Teva Investigational Site 046-0117
state: Arizona
city: Rogers
country: United States
facility: Teva Investigational Site 046-0107
state: Arkansas
city: Anaheim
country: United States
facility: Teva Investigational Site 046-0126
state: California
city: Sacramento
country: United States
facility: Teva Investigational Site 046-0101
state: California
city: San Diego
country: United States
facility: Teva Investigational Site 046-0111
state: California
city: Santa Ana
country: United States
facility: Teva Investigational Site 046-0130
state: California
city: Miami
country: United States
facility: Teva Investigational Site 046-0132
state: Florida
city: Orlando
country: United States
facility: Teva Investigational Site 046-0115
state: Florida
city: Saint Petersburg
country: United States
facility: Teva Investigational Site 046-0114
state: Florida
city: Atlanta
country: United States
facility: Teva Investigational Site 046-0116
state: Georgia
city: Naperville
country: United States
facility: Teva Investigational Site 046-0133
state: Illinois
city: Boston
country: United States
facility: Teva Investigational Site 046-0128
state: Massachusetts
city: Saint Charles
country: United States
facility: Teva Investigational Site 046-0110
state: Missouri
city: Lincoln
country: United States
facility: Teva Investigational Site 046-0134
state: Nebraska
city: Voorhees
country: United States
facility: Teva Investigational Site 046-0109
state: New Jersey
city: New York
country: United States
facility: Teva Investigational Site 046-0124
state: New York
city: Rochester
country: United States
facility: Teva Investigational Site 046-0102
state: New York
city: Rochester
country: United States
facility: Teva Investigational Site 046-0112
state: New York
city: Raleigh
country: United States
facility: Teva Investigational Site 046-0125
state: North Carolina
city: Oklahoma City
country: United States
facility: Teva Investigational Site 046-0106
state: Oklahoma
city: Dallas
country: United States
facility: Teva Investigational Site 046-0113
state: Texas
city: Houston
country: United States
facility: Teva Investigational Site 046-0108
state: Texas
city: Houston
country: United States
facility: Teva Investigational Site 046-0103
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 046-0120
state: Texas
city: Orem
country: United States
facility: Teva Investigational Site 046-0105
state: Utah
city: Petersburg
country: United States
facility: Teva Investigational Site 046-0118
state: Virginia
city: Ajax
country: Canada
facility: Teva Investigational Site 046-0201
state: Ontario
city: Ottawa
country: Canada
facility: Teva Investigational Site 046-0202
state: Ontario
city: Herlev
country: Denmark
facility: Teva Investigational Site 046-0302
city: Odense
country: Denmark
facility: Teva Investigational Site 046-0301
city: Stavropol
country: Russian Federation
facility: Teva Investigational Site 046-0702
city: Tomsk
country: Russian Federation
facility: Teva Investigational Site 046-0704
city: Voronezh
country: Russian Federation
facility: Teva Investigational Site 046-0703
city: Belgrade
country: Serbia
facility: Teva Investigational Site 046-1702
city: Belgrade
country: Serbia
facility: Teva Investigational Site 046-1703
city: Novi Sad
country: Serbia
facility: Teva Investigational Site 046-1701
city: Barcelona
country: Spain
facility: Teva Investigational Site 046-0604
city: Madrid
country: Spain
facility: Teva Investigational Site 046-0605
city: Madrid
country: Spain
facility: Teva Investigational Site 046-0602
city: Malaga
country: Spain
facility: Teva Investigational Site 046-0603
city: Sevilla
country: Spain
facility: Teva Investigational Site 046-0601
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References:
citation: 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.