Trials / Completed
CompletedNCT03571256
A Study to Test if TEV-50717 is Effective in Relieving Tics Associated With Tourette Syndrome (TS)
A Well-Controlled, Fixed-Dose Study of TEV-50717 (Deutetrabenazine) for the Treatment of Tics Associated With Tourette Syndrome
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 158 (actual)
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc. · Industry
- Sex
- All
- Age
- 6 Years – 16 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TEV-50717 | 6-, 9-, 12-, 15-, and 18 mg oral tablets |
| DRUG | Placebo | Placebo matched to TEV-50717 tablets will be taken BID. |
Timeline
- Start date
- 2018-05-31
- Primary completion
- 2019-12-09
- Completion
- 2019-12-09
- First posted
- 2018-06-27
- Last updated
- 2021-11-09
- Results posted
- 2020-06-09
Locations
56 sites across 10 countries: United States, Argentina, Australia, Colombia, Hungary, Italy, Mexico, Poland, South Korea, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03571256. Inclusion in this directory is not an endorsement.