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NCT03813238 · ClinicalTrials.gov registry record · Phase 3
A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents
A Phase 3 study of Cerebral Palsy, Dyskinetic, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 63
- Enrollment target
- 20
- Study locations
NCT03813238 is a Phase 3 study of Cerebral Palsy, Dyskinetic that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 63 participants. The trial reports 20 study locations across 14 states.
The verdict
NCT03813238, a Phase 3 study of Cerebral Palsy, Dyskinetic, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 63 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. 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 167 total studies on file at ClinicalTrials.gov.
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.
NCT03813238 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Georgia, California, Florida.
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.
What interventions are being tested in trial NCT03813238?
The interventions under investigation include: Placebo (DRUG), TEV-50717 (DRUG).
Who is sponsoring clinical trial NCT03813238?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
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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