Clinical trial NCT03571256: A Study to Test if TEV-50717 is Effective in Relieving Tics Associated With Tourette Syndrome (TS)
Official title: A Well-Controlled, Fixed-Dose Study of TEV-50717 (Deutetrabenazine) for the Treatment of Tics Associated With Tourette Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tourette Syndrome
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Nuvelution TS Pharma, Inc.
First posted: 2018-06-27
Enrollment: 158
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: Standard placebo-controlled, double-blind study design (TEV-50717 \[low dose and high dose\] vs. placebo in a 1:1:1 ratio) was chosen to determine whether study drug treatment results in a statistically significant effect on the tics in participants with TS.


Eligibility criteria: Inclusion Criteria:

* Participant weighs at least 44 pounds (20 kg) at baseline.
* Participant meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5™) diagnostic criteria for TS and, in the opinion of the investigator, participant, and parent/legal guardian, the participant's active tics are causing distress or impairment.
* Participant has a TTS of 20 or higher on the YGTSS at screening and baseline.
* Participant is able to swallow study medication whole.
* -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.
* The participant 's predominant movement disorder is stereotypy (coordinated movements that repeat continually and identically) associated with autism spectrum 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 a confirmed diagnosis of bipolar disorder, schizophrenia, or another psychotic disorder.
* Participant has received Comprehensive Behavioral Intervention for Tics for TS or Cognitive Behavioral Therapy for obsessive-compulsive disorder (OCD) within 4 weeks of screening.
* Participant has received treatment with deep brain stimulation, transmagnetic stimulation, or transcranial direct current stimulation within 4 weeks of the screening visit for reduction of tics.
* Participant has a history of torsades de pointes, congenital long QT syndrome, bradyarrhythmias, or uncompensated heart failure.
* Participant has participated in an investigational drug or device study and received investigational medicinal product (IMP)/intervention within 30 days or 5 drug half-lives of baseline, whichever is longer.
* Participant is a pregnant or lactating female, or plans to be pregnant during the study.
* -Additional criteria apply, please contact the investigator for more information

Primary outcomes:
measure: Change From Baseline in the TTS of the YGTSS at Week 8 Between High-Dose TEV-50717-Treated Participants and Placebo-Treated Participants
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Change From Baseline in the Tourette Syndrome-Clinical Global Impression (TS-CGI) Score at Week 8 Between High-Dose TEV-50717-Treated Participants and Placebo-Treated Participants
timeFrame: Baseline, Week 8
measure: Change From Baseline in the TTS of the YGTSS at Week 8 Between Low-Dose TEV-50717-Treated Participants and Placebo-Treated Participants
timeFrame: Baseline, Week 8
measure: Change From Baseline in the TS-CGI Score at Week 8 Between Low-Dose TEV-50717-Treated Participants and Placebo-Treated Participants
timeFrame: Baseline, Week 8
measure: Change From Baseline in the Tourette Syndrome-Patient Global Impression of Impact (TS-PGII) Score at Week 8 Between High-Dose TEV-50717-Treated Participants and Placebo-Treated Participants
timeFrame: Baseline, Week 8
measure: Change From Baseline in the TS-PGII Score at Week 8 Between Low-Dose TEV-50717-Treated Participants and Placebo-Treated Participants
timeFrame: Baseline, Week 8
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 8 Between High-Dose TEV-50717-Treated Participants and Placebo-Treated Participants
timeFrame: Baseline, Week 8
measure: Change From Baseline in the C&A-GTS-QOL ADL Subscale Score at Week 8 Between Low-Dose TEV-50717-Treated Participants and Placebo-Treated Participants
timeFrame: Baseline, Week 8
measure: Change From Baseline in the Children's Depression Inventory Second Edition (CDI-2; Parent Version and Self-reported Version) Total Score at Week 9
timeFrame: Baseline, Week 9
measure: Number of Participants at Baseline and Week 9 With Any Suicidal Ideation or Suicidal Behavior According to the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline, Week 9
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Teva Investigational Site 060-0160
state: Florida
city: Gulf Breeze
country: United States
facility: Teva Investigational Site 060-0166
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 060-0161
state: Florida
city: Orlando
country: United States
facility: Teva Investigational Site 060-0151
state: Florida
city: Orlando
country: United States
facility: Teva Investigational Site 060-0153
state: Florida
city: Atlanta
country: United States
facility: Teva Investigational Site 060-0168
state: Georgia
city: Chicago
country: United States
facility: Teva Investigational Site 060-0155
state: Illinois
city: Chicago
country: United States
facility: Teva Investigational Site 060-0164
state: Illinois
city: Indianapolis
country: United States
facility: Teva Investigational Site 060-0152
state: Indiana
city: Louisville
country: United States
facility: Teva Investigational Site 060-0158
state: Kentucky
city: Rockville
country: United States
facility: Teva Investigational Site 060-0167
state: Maryland
city: Ann Arbor
country: United States
facility: Teva Investigational Site 060-0165
state: Michigan
city: Bridgeton
country: United States
facility: Teva Investigational Site 060-0170
state: Missouri
city: New York
country: United States
facility: Teva Investigational Site 060-0154
state: New York
city: Charleston
country: United States
facility: Teva Investigational Site 060-0169
state: South Carolina
city: Memphis
country: United States
facility: Teva Investigational Site 060-0157
state: Tennessee
city: Nashville
country: United States
facility: Teva Investigational Site 060-0156
state: Tennessee
city: Fort Worth
country: United States
facility: Teva Investigational Site 060-0163
state: Texas
city: Everett
country: United States
facility: Teva Investigational Site 060-0162
state: Washington
city: Buenos Aires
country: Argentina
facility: Teva Investigational Site 060-1407
city: Buenos Aires
country: Argentina
facility: Teva Investigational Site 060-1401
city: Buenos Aires
country: Argentina
facility: Teva Investigational Site 060-1402
city: La Plata
country: Argentina
facility: Teva Investigational Site 060-1403
city: Mendoza
country: Argentina
facility: Teva Investigational Site 060-1404
city: Liverpool
country: Australia
facility: Teva Investigational Site 060-1802
city: Parkville
country: Australia
facility: Teva Investigational Site 060-1801
city: Bello
country: Colombia
facility: Teva Investigational Site 060-1503
city: Medellin
country: Colombia
facility: Teva Investigational Site 060-1501
city: Medellin
country: Colombia
facility: Teva Investigational Site 060-1506
city: Pereira
country: Colombia
facility: Teva Investigational Site 060-1504
city: Budapest
country: Hungary
facility: Teva Investigational Site 060-0901
city: Szeged
country: Hungary
facility: Teva Investigational Site 060-0902
city: Cagliari
country: Italy
facility: Teva Investigational Site 060-1005
city: Catania
country: Italy
facility: Teva Investigational Site 060-1001
city: Naples
country: Italy
facility: Teva Investigational Site 060-1003
city: Rome
country: Italy
facility: Teva Investigational Site 060-1004
city: Seoul
country: Korea, Republic of
facility: Teva Investigational Site 060-1901
city: Seoul
country: Korea, Republic of
facility: Teva Investigational Site 060-1903
city: Seoul
country: Korea, Republic of
facility: Teva Investigational Site 060-1904
city: Seoul
country: Korea, Republic of
facility: Teva Investigational Site 060-1902
city: Culiacan
country: Mexico
facility: Teva Investigational Site 060-1601
city: Leon
country: Mexico
facility: Teva Investigational Site 060-1603
city: Monterrey
country: Mexico
facility: Teva Investigational Site 060-1602
city: Monterrey
country: Mexico
facility: Teva Investigational Site 060-1604
city: Gdansk
country: Poland
facility: Teva Investigational Site 060-1104
city: Katowice
country: Poland
facility: Teva Investigational Site 060-1101
city: Krakow
country: Poland
facility: Teva Investigational Site 060-1105
city: Poznan
country: Poland
facility: Teva Investigational Site 060-1102
city: Torun
country: Poland
facility: Teva Investigational Site 060-1106
city: Warsaw
country: Poland
facility: Teva Investigational Site 060-1103
city: Dnipropetrovsk
country: Ukraine
facility: Teva Investigational Site 060-2003
city: Kharkiv
country: Ukraine
facility: Teva Investigational Site 060-2001
city: Kharkiv
country: Ukraine
facility: Teva Investigational Site 060-2002
city: Kiev
country: Ukraine
facility: Teva Investigational Site 060-2007
city: Kyiv
country: Ukraine
facility: Teva Investigational Site 060-2005
city: Vinnytsia
country: Ukraine
facility: Teva Investigational Site 060-2006
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References:
citation: Coffey B, Jankovic J, Claassen DO, Jimenez-Shahed J, Gertz BJ, Garofalo EA, Stamler DA, Wieman M, Savola JM, Gordon MF, Alexander JK, Barkay H, Harary E. Efficacy and Safety of Fixed-Dose Deutetrabenazine in Children and Adolescents for Tics Associated With Tourette Syndrome: A Randomized Clinical Trial. JAMA Netw Open. 2021 Oct 1;4(10):e2129397. doi: 10.1001/jamanetworkopen.2021.29397.