WithdrawnPhase 4

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

Stopped: Not funded

United States0Started 2025-01

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 w…

What they're measuring

Change in AIMS total scores of items 1-7

Timeframe: Baseline and 24 weeks from start of treatment

Trial details

NCT IDNCT06107829

SponsorStephen Ruedrich

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01