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

NCT03567291 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2021-11-09

Study results available
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Summary

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.

Conditions

  • Tourette Syndrome

Interventions

DRUG

TEV-50717

6, 9, and 12 mg oral tablets

DRUG

Placebo

Placebo comparator

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
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-25
Primary Completion
2020-05-15
Completion
2020-05-15
FDA Drug
Yes

Countries

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

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 NCT03567291 on ClinicalTrials.gov