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

NCT03452943 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2021-11-09

Study results available
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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.

Conditions

  • Tourette Syndrome

Interventions

DRUG

TEV-50717

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Nuvelution TS Pharma, Inc.

    collaborator INDUSTRY

  • Teva Branded Pharmaceutical Products R&D, Inc.

    lead INDUSTRY

Principal Investigators

  • Teva Medical Expert, MD · Teva Branded Pharmaceutical Products R&D, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-05
Primary Completion
2019-11-12
Completion
2019-11-12
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Denmark
  • Russia
  • Serbia
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03452943 on ClinicalTrials.gov