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Valbenazine Treatment of Tardive Dyskinesia in Adults With Intellectual/Developmental Disabilities

NCT06107829 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2024-10-24

No results posted yet for this study

Summary

The goal of this open-label clinical trial is to test the safety and efficacy of valbenazine treatment in patients with Intellectual/Developmental Disability (IDD) who have a diagnosis of Tardive dyskinesia (TD). The main questions this study aims to answer are:

* Does valbenazine treatment of TD in the previously untreated patient population of adults with IDD produce comparable amelioration of signs of movement disorder as what has historically been reported in adults without IDD?
* Is valbenazine treatment of TD in persons with IDD as safe as what has historically been reported in adults without IDD?
* Does valbenazine treatment improve Quality of Life (QOL) in persons with IDD and TD treated with valbenazine?
* Does valbenazine treatment produce positive change in Activities of Daily Living (ADLs) in persons with IDD and TD?
* Does valbenazine treatment of TD in persons with IDD reduce caregiver burden?

In this study, 25 participants with IDD and TD will undergo valbenazine treatment for 24 weeks. The participants will be seen for a total of 5 visits: at baseline, and at follow up visits at 3 weeks, 6 weeks, 12 weeks, and 24 weeks.

This study does not include a comparison group. Therefore, researchers will compare the response of the study participants to valbenazine treatment with those from a previous reported work that resulted in the FDA approval of this medication.

Conditions

  • Tardive Dyskinesia
  • Intellectual Disability
  • Developmental Disabilities

Interventions

DRUG

Valbenazine Oral Capsule

Open-label twenty-four-week treatment with valbenazine oral capsules (up to 80 mg/day) to test the safety and effectiveness of this medication in ameliorating the signs of tardive dyskinesia in persons with intellectual disability.

Sponsors & Collaborators

  • Neurocrine Biosciences

    collaborator INDUSTRY

  • Stephen Ruedrich

    lead OTHER

Principal Investigators

  • Stephen Ruedrich, MD · University Hospitals Cleveland Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-31
Primary Completion
2027-01-31
Completion
2027-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06107829 on ClinicalTrials.gov