A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents
Public ClinicalTrials.gov record NCT03813238. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Placebo-Controlled Study of TEV-50717 (Deutetrabenazine) for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
CP (cerebral palsy) refers to a group of neurological disorders that appear in infancy or early childhood and permanently affect body movement and muscle coordination. CP is caused by damage to or abnormalities inside the developing brain that disrupt the brain's ability to control movement and maintain posture and balance. The signs of CP usually appear in the early months of life, although specific diagnosis may be delayed until the age of 2 years or older. TEV-50717 (deutetrabenazine, also known as SD-809) has already provided evidence for safe and effective use in 2 other hyperkinetic movement disorders, namely chorea in Huntington's disease (HD) and tardive dyskinesia (TD). Currently, there is no approved treatment available for Dyskinesia in cerebral palsy (DCP). The available treatment options address some of the manifestations of DCP. The study population will include pediatric and adolescent participants (6 through 18 years of age) with DCP with predominant choreiform movement disorder, who have had nonprogressive CP symptoms since infancy (≤2 years of age). Diagnosis of DCP is based on the Surveillance of Cerebral Palsy in Europe criteria. This is a Phase 3 study that will evaluate the efficacy and safety of TEV-50717 administered as oral tablets at a starting dose of 6 mg once daily in participants (age 6 through 18 years, inclusive) with DCP with predominant choreiform movement disorder. The study will be conducted in multiple centers and will use 2 parallel treatment groups (ie, TEV-50717 and placebo) in which participants will be randomized in a 2:1 ratio. "Predominant" in this instance indicates that the choreiform movement disorder is the main cause of impairment or distress.
Study identification
- NCT ID
- NCT03813238
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 63 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Years to 18 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 6, 2019 (Actual)
- Primary completion
- Jul 5, 2022 (Actual)
- Completion
- Jul 21, 2022 (Actual)
- Last update posted
- Sep 8, 2023
2019 – 2022
United States locations
- U.S. sites
- 23
- U.S. states
- 17
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Teva Investigational Site 14137 | Birmingham | Alabama | 35233 | — |
| Teva Investigational Site 14224 | Phoenix | Arizona | 85016 | — |
| Teva Investigational Site 14227 | Loma Linda | California | 92354 | — |
| Teva Investigational Site 14295 | San Diego | California | 92123 | — |
| Teva Investigational Site 14293 | Washington D.C. | District of Columbia | 20010 | — |
| Teva Investigational Site 14127 | Miami | Florida | 33155 | — |
| Teva Investigational Site 14125 | Tampa | Florida | 33609 | — |
| Teva Investigational Site 14136 | Atlanta | Georgia | 30318 | — |
| Teva Investigational Site 14291 | Atlanta | Georgia | 30328 | — |
| Teva Investigational Site 14130 | Savannah | Georgia | 31406 | — |
| Teva Investigational Site 14290 | New Orleans | Louisiana | 70118-5720 | — |
| Teva Investigational Site 14226 | Saint Paul | Minnesota | 55101 | — |
| Teva Investigational Site 14134 | Lincoln | Nebraska | 68526 | — |
| Teva Investigational Site 14122 | Gibbsboro | New Jersey | 08026 | — |
| Teva Investigational Site 14297 | New Brunswick | New Jersey | 08901 | — |
| Teva Investigational Site 14225 | New York | New York | 10032 | — |
| Teva Investigational Site 14123 | Rochester | New York | 14642 | — |
| Teva Investigational Site 14348 | Portland | Oregon | 97239 | — |
| Teva Investigational Site 14299 | Charleston | South Carolina | 29414 | — |
| Teva Investigational Site 14129 | Nashville | Tennessee | 37232 | — |
| Teva Investigational Site 14228 | Houston | Texas | 77030 | — |
| Teva Investigational Site 14223 | Richmond | Virginia | 23298 | — |
| Teva Investigational Site 14135 | Everett | Washington | 98201 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 47 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03813238, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 8, 2023 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03813238 live on ClinicalTrials.gov.