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

Withdrawn before enrolling · Phase 4

Conditions studied: Tardive Dyskinesia, Intellectual Disability, Developmental Disabilities

In brief

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.

Key facts

Study ID

NCT06107829

Run by

Stephen Ruedrich

People needed

0

Starts

2025-01-01

Expected to finish

2027-02-01

Last updated by the study team

2024-10-24

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University Hospitals of Cleveland — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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