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Evaluation of Safety and Tolerability of Long-term TEV-50717 (Deutetrabenazine) for Treatment of Tourette Syndrome in Children and Adolescents

NCT ID: NCT03567291

Last Updated: 2021-11-09

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-25

Study Completion Date

2020-05-15

Brief Summary

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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

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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

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Tourette Syndrome

Keywords

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adolescents children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TEV-50717- Part A

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.

Group Type EXPERIMENTAL

TEV-50717

Intervention Type DRUG

6, 9, and 12 mg oral tablets

TEV-50717- Part B RW

TEV-50717 is administered during Part B Randomized Drug Withdrawal (RW) 2-week period.

Group Type EXPERIMENTAL

TEV-50717

Intervention Type DRUG

6, 9, and 12 mg oral tablets

Placebo- Part B RW

Placebo is administered during Part B Randomized Drug Withdrawal (RW) 2-week period only.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo comparator

Interventions

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TEV-50717

6, 9, and 12 mg oral tablets

Intervention Type DRUG

Placebo

Placebo comparator

Intervention Type DRUG

Other Intervention Names

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deutetrabenazine, SD-809

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nuvelution TS Pharma, Inc.

INDUSTRY

Sponsor Role collaborator

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Teva Medical Expert, MD

Role: STUDY_DIRECTOR

Teva Branded Pharmaceutical Products R&D, Inc.

Locations

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Teva Investigational Site 046-0104

Dothan, Alabama, United States

Site Status

Teva Investigational Site 046-0107

Rogers, Arkansas, United States

Site Status

Teva Investigational Site 046-0126

Anaheim, California, United States

Site Status

Teva Investigational Site 046-0101

Sacramento, California, United States

Site Status

Teva Investigational Site 046-0111

San Diego, California, United States

Site Status

Teva Investigational Site 060-0160

Gainesville, Florida, United States

Site Status

Teva Investigational Site 060-0166

Gulf Breeze, Florida, United States

Site Status

Teva Investigational Site 060-0161

Miami, Florida, United States

Site Status

Teva Investigational Site 046-0115

Orlando, Florida, United States

Site Status

Teva Investigational Site 060-0153

Orlando, Florida, United States

Site Status

Teva Investigational Site 046-0114

St. Petersburg, Florida, United States

Site Status

Teva Investigational Site 046-0116

Atlanta, Georgia, United States

Site Status

Teva Investigational Site 060-0155

Chicago, Illinois, United States

Site Status

Teva Investigational Site 060-0164

Chicago, Illinois, United States

Site Status

Teva Investigational Site 046-0133

Naperville, Illinois, United States

Site Status

Teva Investigational Site 046-0128

Boston, Massachusetts, United States

Site Status

Teva Investigational Site 060-0170

Bridgeton, Missouri, United States

Site Status

Teva Investigational Site 046-0110

Saint Charles, Missouri, United States

Site Status

Teva Investigational Site 046-0134

Lincoln, Nebraska, United States

Site Status

Teva Investigational Site 046-0109

Voorhees Township, New Jersey, United States

Site Status

Teva Investigational Site 046-0124

New York, New York, United States

Site Status

Teva Investigational Site 060-0154

New York, New York, United States

Site Status

Teva Investigational Site 046-0102

Rochester, New York, United States

Site Status

Teva Investigational Site 046-0106

Oklahoma City, Oklahoma, United States

Site Status

Teva Investigational Site 060-0169

Charleston, South Carolina, United States

Site Status

Teva Investigational Site 060-0156

Nashville, Tennessee, United States

Site Status

Teva Investigational Site 046-0113

Dallas, Texas, United States

Site Status

Teva Investigational Site 060-0163

Fort Worth, Texas, United States

Site Status

Teva Investigational Site 046-0108

Houston, Texas, United States

Site Status

Teva Investigational Site 046-0120

San Antonio, Texas, United States

Site Status

Teva Investigational Site 046-0105

Orem, Utah, United States

Site Status

Teva Investigational Site 046-0118

Petersburg, Virginia, United States

Site Status

Teva Investigational Site 060-0162

Everett, Washington, United States

Site Status

Teva Investigational Site 060-1407

Buenos Aires, , Argentina

Site Status

Teva Investigational Site 060-1402

Buenos Aires, , Argentina

Site Status

Teva Investigational Site 060-1403

La Plata, , Argentina

Site Status

Teva Investigational Site 060-1404

Mendoza, , Argentina

Site Status

Teva Investigational Site 060-1802

Liverpool, , Australia

Site Status

Teva Investigational Site 046-0201

Ajax, Ontario, Canada

Site Status

Teva Investigational Site 046-0202

Ottawa, Ontario, Canada

Site Status

Teva Investigational Site 060-1503

Bello, , Colombia

Site Status

Teva Investigational Site 060-1504

Pereira, , Colombia

Site Status

Teva Investigational Site 046-0302

Herlev, , Denmark

Site Status

Teva Investigational Site 046-0301

Odense, , Denmark

Site Status

Teva Investigational Site 060-0901

Budapest, , Hungary

Site Status

Teva Investigational Site 060-0902

Szeged, , Hungary

Site Status

Teva Investigational Site 060-1005

Cagliari, , Italy

Site Status

Teva Investigational Site 060-1001

Catania, , Italy

Site Status

Teva Investigational Site 060-1003

Naples, , Italy

Site Status

Teva Investigational Site 060-1601

Culiacán, , Mexico

Site Status

Teva Investigational Site 060-1603

León, , Mexico

Site Status

Teva Investigational Site 060-1602

Monterrey, , Mexico

Site Status

Teva Investigational Site 060-1604

Monterrey, , Mexico

Site Status

Teva Investigational Site 060-1104

Gdansk, , Poland

Site Status

Teva Investigational Site 060-1101

Katowice, , Poland

Site Status

Teva Investigational Site 060-1105

Krakow, , Poland

Site Status

Teva Investigational Site 060-1102

Poznan, , Poland

Site Status

Teva Investigational Site 060-1103

Warsaw, , Poland

Site Status

Teva Investigational Site 046-0704

Tomsk, , Russia

Site Status

Teva Investigational Site 046-0703

Voronezh, , Russia

Site Status

Teva Investigational Site 046-1702

Belgrade, , Serbia

Site Status

Teva Investigational Site 046-1703

Belgrade, , Serbia

Site Status

Teva Investigational Site 046-1701

Novi Sad, , Serbia

Site Status

Teva Investigational Site 060-1901

Seoul, , South Korea

Site Status

Teva Investigational Site 060-1903

Seoul, , South Korea

Site Status

Teva Investigational Site 060-1902

Seoul, , South Korea

Site Status

Teva Investigational Site 046-0605

Madrid, , Spain

Site Status

Teva Investigational Site 046-0602

Madrid, , Spain

Site Status

Teva Investigational Site 046-0603

Málaga, , Spain

Site Status

Teva Investigational Site 046-0601

Seville, , Spain

Site Status

Teva Investigational Site 060-2003

Dnipropetrovsk, , Ukraine

Site Status

Teva Investigational Site 060-2001

Kharkiv, , Ukraine

Site Status

Teva Investigational Site 060-2002

Kharkiv, , Ukraine

Site Status

Teva Investigational Site 060-2007

Kiev, , Ukraine

Site Status

Teva Investigational Site 060-2005

Kyiv, , Ukraine

Site Status

Teva Investigational Site 060-2006

Vinnytsia, , Ukraine

Site Status

Countries

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United States Argentina Australia Canada Colombia Denmark Hungary Italy Mexico Poland Russia Serbia South Korea Spain Ukraine

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2016-000630-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TV50717-CNS-30047

Identifier Type: -

Identifier Source: org_study_id