Study to Assess the Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Dyskinesia Due to Cerebral Palsy
NCT ID: NCT05206513
Last Updated: 2025-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
86 participants
INTERVENTIONAL
2022-04-15
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo dosed for 14 weeks (double-blind treatment period) followed by open-label valbenazine treatment.
Participants may opt to enter an open-label valbenazine treatment extension phase.
Placebo
Capsule, administered once daily orally or via gastrostomy/gastrojejunostomy tube
Valbenazine
Capsule, administered once daily orally or via gastrostomy/gastrojejunostomy tube
Valbenazine
Valbenazine dosed for 14 weeks (double-blind treatment period) followed by open-label valbenazine treatment.
Participants may opt to enter an open-label valbenazine treatment extension phase.
Valbenazine
Capsule, administered once daily orally or via gastrostomy/gastrojejunostomy tube
Interventions
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Placebo
Capsule, administered once daily orally or via gastrostomy/gastrojejunostomy tube
Valbenazine
Capsule, administered once daily orally or via gastrostomy/gastrojejunostomy tube
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Medical conditions are stable and expected to remain stable throughout the study.
Exclusion Criteria
1. Are pregnant or breastfeeding.
2. Have a clinical diagnosis or history of dyskinesia due to condition other than CP.
3. Have inability to swallow soft foods, unless medications can be administered via gastrostomy/gastrojejunostomy tube.
4. Have any suicidal behavior or suicidal ideation in the year prior to screening or on Day 1.
5. Is a substance abuser of any compound.
6. Known history of long QT syndrome or cardiac tachyarrhythmia, or clinically significant electrocardiogram (ECG) abnormalities.
6 Years
70 Years
ALL
No
Sponsors
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Neurocrine Biosciences
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development Lead
Role: STUDY_DIRECTOR
Neurocrine Biosciences
Locations
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Neurocrine Clinical Site
San Diego, California, United States
Neurocrine Clinical Site
Aurora, Colorado, United States
Neurocrine Clinical Site
Stamford, Connecticut, United States
Neurocrine Clinical Site
Gulf Breeze, Florida, United States
Neurocrine Clinical Site
Miami, Florida, United States
Neurocrine Clinical Site
Orlando, Florida, United States
Neurocrine Clinical Site
Chicago, Illinois, United States
Neurocrine Clinical Site
Baltimore, Maryland, United States
Neurocrine Clinical Site
Boston, Massachusetts, United States
Neurocrine Clinical Site
Farmington Hills, Michigan, United States
Neurocrine Clinical Site
Saint Paul, Minnesota, United States
Neurocrine Clinical Site
New York, New York, United States
Neurocrine Clinical Site
Cincinnati, Ohio, United States
Neurocrine Clinical Site
Columbus, Ohio, United States
Neurocrine Clinical Site
Oklahoma City, Oklahoma, United States
Neurocrine Clinical Site
Portland, Oregon, United States
Neurocrine Clinical Site
Dallas, Texas, United States
Neurocrine Clinical Site
Fort Worth, Texas, United States
Neurocrine Clinical Site
Houston, Texas, United States
Neurocrine Clinical Site
Buenos Aires, , Argentina
Neurocrine Clinical Site
Buenos Aires, , Argentina
Neurocrine Clinical Site
Brussels, , Belgium
Neurocrine Clinical Site
Brasília, , Brazil
Neurocrine Clinical Site
Curitiba, , Brazil
Neurocrine Clinical Site
Porto Alegre, , Brazil
Neurocrine Clinical Site
Porto Alegre, , Brazil
Neurocrine Clinical Site
Ẕerifin, , Israel
Neurocrine Clinical Site
Calambrone, , Italy
Neurocrine Clinical Site
Milan, , Italy
Neurocrine Clinical Site
Aguascalientes, , Mexico
Neurocrine Clinical Site
Gdansk, , Poland
Neurocrine Clinical Site
Krakow, , Poland
Neurocrine Clinical Site
Oświęcim, , Poland
Neurocrine Clinical Site
Lisbon, , Portugal
Neurocrine Clinical Site
Lisbon, , Portugal
Neurocrine Clinical Site
Porto, , Portugal
Neurocrine Clinical Site
Barcelona, , Spain
Neurocrine Clinical Site
Madrid, , Spain
Countries
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Other Identifiers
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EUCT
Identifier Type: OTHER
Identifier Source: secondary_id
NBI-98854-DCP3018
Identifier Type: -
Identifier Source: org_study_id
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