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NCT03571256 · ClinicalTrials.gov registry record · Phase 3
A Study to Test if TEV-50717 is Effective in Relieving Tics Associated With Tourette Syndrome (TS)
A Phase 3 study of Tourette Syndrome, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 158
- Enrollment target
- 20
- Study locations
NCT03571256: Completed Phase 3 study of Tourette Syndrome, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT03571256 is a Phase 3 study of Tourette Syndrome that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 158 participants, above the 82-participant average among 33 other Tourette Syndrome trials with a reported enrollment target (93% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03571256, a Phase 3 study of Tourette Syndrome, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 158 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
YGTSS rating scale is a semi-structured clinician rating instrument that provides an evaluation of the number, frequency, intensity, complexity, and interference of motor and phonic tics. YGTSS is composed of 11 items: 5 items for motor tic severity, 5 items for vocal tic severity, and 1 item for impairment. Each item for motor tic severity and vocal is rated on a 6-point scale (0 for none to 5 to severe). MTSS is the sum of the 5 items for motor tic severity and VTSS is the sum of the 5 items f
Conditions Studied
Interventions
- DRUG Placebo
- DRUG TEV-50717
Study Locations (20)
Florida
- Teva Investigational Site 060-0160 - Gainesville
- Teva Investigational Site 060-0166 - Gulf Breeze
- Teva Investigational Site 060-0161 - Miami
- Teva Investigational Site 060-0151 - Orlando
- Teva Investigational Site 060-0153 - Orlando
Illinois
- Teva Investigational Site 060-0155 - Chicago
- Teva Investigational Site 060-0164 - Chicago
Tennessee
- Teva Investigational Site 060-0157 - Memphis
- Teva Investigational Site 060-0156 - Nashville
Georgia
- Teva Investigational Site 060-0168 - Atlanta
Indiana
- Teva Investigational Site 060-0152 - Indianapolis
Kentucky
- Teva Investigational Site 060-0158 - Louisville
Maryland
- Teva Investigational Site 060-0167 - Rockville
Michigan
- Teva Investigational Site 060-0165 - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 158 participants |
| Start Date | 2018-05-31 |
| Est. Completion | 2019-12-09 |
| Phase | Phase 3 |
What the finished NCT03571256 record still lists
NCT03571256 is an interventional study that assigns participants to a tested intervention. The registered 158 participants enrollment target is mid-sized for trials with a published cap, above the 82-participant average among 33 other Tourette Syndrome trials with a reported enrollment target (93% higher).
The record links to 1 condition, with Tourette Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03571256 names 20 study sites across 14 states, led by Florida, Illinois, Tennessee.
Frequently Asked Questions
What is clinical trial NCT03571256 about?
NCT03571256 is a clinical study titled "A Study to Test if TEV-50717 is Effective in Relieving Tics Associated With Tourette Syndrome (TS)". 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.
What is the current status of trial NCT03571256?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 158 participants. The study started on 2018-05-31. Estimated completion is 2019-12-09.
What conditions does trial NCT03571256 study?
This clinical trial studies the following conditions: Tourette Syndrome.
What interventions are being tested in trial NCT03571256?
The interventions under investigation include: Placebo (DRUG), TEV-50717 (DRUG).
Who is sponsoring clinical trial NCT03571256?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03571256 being conducted?
This trial has 20 study locations across Florida, Georgia, Illinois, Indiana, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Tourette Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03571256's enrollment target sits among peer trials
158 6th of 33 higher than 28 of 33 other Tourette Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tourette Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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