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A Study to Test if TEV-50717 is Effective in Relieving Tics Associated With Tourette Syndrome (TS)

NCT03571256 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2021-11-09

Study results available
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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.

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.

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
2018-05-31
Primary Completion
2019-12-09
Completion
2019-12-09
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Colombia
  • Hungary
  • Italy
  • Mexico
  • Poland
  • South Korea
  • 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 NCT03571256 on ClinicalTrials.gov