ACTIVE_NOT_RECRUITING

Study to Assess the Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Dyskinesia Due to Cerebral Palsy

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Conditions

DyskinesiaCerebral PalsyVesicular monoamine transporter 2 (VMAT2) inhibitorNeurocrineValbenazineNBI-98854DystoniaChoreaAthetosisAthetoid cerebral palsyChoreoathetosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary objective of this study is to evaluate the efficacy of valbenazine versus placebo on improving chorea in pediatric and adult participants who have dyskinesia due to cerebral palsy (DCP) with choreiform movements.

Official Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Dyskinesia Due to Cerebral Palsy

Quick Facts

Study Start:2022-04-15
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05206513

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Medically confirmed diagnosis of DCP (that is, a hyperkinetic movement disorder due to cerebral palsy \[CP\]) with choreiform movements.
  2. 2. Medical conditions are stable and expected to remain stable throughout the study.
  1. 1. Are pregnant or breastfeeding.
  2. 2. Have a clinical diagnosis or history of dyskinesia due to condition other than CP.
  3. 3. Have inability to swallow soft foods, unless medications can be administered via gastrostomy/gastrojejunostomy tube.
  4. 4. Have any suicidal behavior or suicidal ideation in the year prior to screening or on Day 1.
  5. 5. Is a substance abuser of any compound.
  6. 6. Known history of long QT syndrome or cardiac tachyarrhythmia, or clinically significant electrocardiogram (ECG) abnormalities.

Contacts and Locations

Principal Investigator

Clinical Development Lead
STUDY_DIRECTOR
Neurocrine Biosciences

Study Locations (Sites)

Neurocrine Clinical Site
San Diego, California, 92123
United States
Neurocrine Clinical Site
Aurora, Colorado, 80045
United States
Neurocrine Clinical Site
Stamford, Connecticut, 06905
United States
Neurocrine Clinical Site
Gulf Breeze, Florida, 32561
United States
Neurocrine Clinical Site
Miami, Florida, 33155
United States
Neurocrine Clinical Site
Orlando, Florida, 32806
United States
Neurocrine Clinical Site
Chicago, Illinois, 60611
United States
Neurocrine Clinical Site
Baltimore, Maryland, 21205
United States
Neurocrine Clinical Site
Boston, Massachusetts, 02115
United States
Neurocrine Clinical Site
Farmington Hills, Michigan, 48334
United States
Neurocrine Clinical Site
Saint Paul, Minnesota, 55101
United States
Neurocrine Clinical Site
New York, New York, 10003
United States
Neurocrine Clinical Site
Cincinnati, Ohio, 45229
United States
Neurocrine Clinical Site
Columbus, Ohio, 43205
United States
Neurocrine Clinical Site
Oklahoma City, Oklahoma, 73120
United States
Neurocrine Clinical Site
Portland, Oregon, 97239
United States
Neurocrine Clinical Site
Dallas, Texas, 75390-8857
United States
Neurocrine Clinical Site
Fort Worth, Texas, 76104
United States
Neurocrine Clinical Site
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Neurocrine Biosciences

  • Clinical Development Lead, STUDY_DIRECTOR, Neurocrine Biosciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-15
Study Completion Date2026-06

Study Record Updates

Study Start Date2022-04-15
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

  • Cerebral Palsy
  • Vesicular monoamine transporter 2 (VMAT2) inhibitor
  • Dyskinesia
  • Neurocrine
  • Valbenazine
  • NBI-98854
  • Dystonia
  • Chorea
  • Athetosis
  • Athetoid cerebral palsy
  • Choreoathetosis

Additional Relevant MeSH Terms

  • Dyskinesia
  • Cerebral Palsy