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A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents
NCT03813238 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG TEV-50717
Study Locations (20)
Georgia
- Teva Investigational Site 14136 — Atlanta
- Teva Investigational Site 14291 — Atlanta
- Teva Investigational Site 14130 — Savannah
California
- Teva Investigational Site 14227 — Loma Linda
- Teva Investigational Site 14295 — San Diego
Florida
- Teva Investigational Site 14127 — Miami
- Teva Investigational Site 14125 — Tampa
New Jersey
- Teva Investigational Site 14122 — Gibbsboro
- Teva Investigational Site 14297 — New Brunswick
New York
- Teva Investigational Site 14225 — New York
- Teva Investigational Site 14123 — Rochester
Alabama
- Teva Investigational Site 14137 — Birmingham
Arizona
- Teva Investigational Site 14224 — Phoenix
District of Columbia
- Teva Investigational Site 14293 — Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2019-08-06 |
| Est. Completion | 2022-07-21 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03813238
The ClinicalTrials.gov registry entry for NCT03813238 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Teva Branded Pharmaceutical Products R&D, which has 103 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Cerebral Palsy, Dyskinetic appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03813238 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Georgia, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03813238 about?
NCT03813238 is a clinical study titled "A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents". 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 main...
What is the current status of trial NCT03813238?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 63 participants. The study started on 2019-08-06. Estimated completion is 2022-07-21.
What conditions does trial NCT03813238 study?
This clinical trial studies the following conditions: Cerebral Palsy, Dyskinetic. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03813238?
The interventions under investigation include: Placebo (DRUG), TEV-50717 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03813238?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 103 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03813238 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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