Trials / Completed
CompletedNCT03452943
Alternatives for Reducing Tics in Tourette Syndrome (TS): A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents
A Randomized, Double-blind, Placebo-controlled Study of TEV-50717 (Deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 119 (actual)
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc. · Industry
- Sex
- All
- Age
- 6 Years – 16 Years
- Healthy volunteers
- Not accepted
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
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 for 12 weeks. |
Timeline
- Start date
- 2018-02-05
- Primary completion
- 2019-11-12
- Completion
- 2019-11-12
- First posted
- 2018-03-02
- Last updated
- 2021-11-09
- Results posted
- 2020-06-04
Locations
42 sites across 6 countries: United States, Canada, Denmark, Russia, Serbia, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03452943. Inclusion in this directory is not an endorsement.