NOT_YET_RECRUITING
Valbenazine Treatment of Tardive Dyskinesia in Adults With Intellectual/Developmental Disabilities
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
🗓️ Study Start (Actual) August 2024
🗓️ Primary Completion (Estimated) August 2026
✅ Study Completion (Estimated) August 2026
👥 Enrollment (Estimated) 25
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Cleveland, Ohio, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Diagnosis of IDD (IQ \< 70; social/adaptive dysfunction, onset \< age 22) as per DSM-5
    • * Clinical diagnosis of Tardive Dyskinesia (TD) per DSM-5 for at least 3 months before study inclusion (presence of movement disorder for at least 3 months, in absence of previous formal diagnosis of TD).
    • * Eligible to receive valbenazine according to current product labeling.
    • * Stable doses of all psychotropic medications for minimum of three months before study inclusion.
    • * Willing to remain on stable doses of all psychotropics for 24 weeks of study. If female of childbearing age, practicing acceptable form for birth control throughout study duration.
    • * Subject able to comply with scheduled visits and assessments.
    • * Consent of subject, or legally authorized representative to study protocol.

    Exclusion Criteria:

    • * Previous treatment with a VMAT2 inhibitor (tetrabenazine, valbenazine, or deutetrabenazine).
    • * Treatment with any investigational drug in the 30 days prior to study entry.
    • * Currently taking a strong CYP3A4 inducer such as carbamazepine, phenobarbital, diphenylhydantoin, or primidone.
    • * Any unstable medical condition in the 60 days prior to study entry.
    • * Pregnant or breast-feeding.
    • * Inability to take study medication.
    • * History of neuroleptic malignant syndrome.
    • * History of long QTc on electrocardiogram, bundle branch block (BBB), atrioventricular block, serious cardiac arrhythmia, or heart failure.
    • * QTc on EKG \> 450 msec (Fredericia formula) on EKG within 3 months prior to study entry.
    • * History of substance abuse or dependence in the 3 months prior to study entry.
    • * Significant risk of suicide or dangerous aggression to others at time of or 3 months prior to study entry.
Ages Eligible for Study: 18 Years to 70 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 25 October 2023
  • First Submitted that Met QC Criteria 25 October 2023
  • First Posted 30 October 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 1 May 2024
  • Last Update Posted 3 May 2024
  • Last Verified May 2024