Study of Deutetrabenazine to Treat Tardive Dyskinesia in Adults with Intellectual and Developmental Disabilities and Psychiatric or Behavioral Conditions

What this Trial Is About

Researchers are evaluating the effects of deutetrabenazine on tardive dyskinesia TD in adults with intellectual and developmental disabilities IDD who have not been previously treated for TD. This open-label Phase 4 study aims to compare treatment responses in this group to published results from patients without IDD. The study will also assess safety, changes in daily living activities, quality of life, and caregiver burden using validated measurement tools. Participants will receive deutetrabenazine oral capsules with doses titrated from 12 mg to 24 mg per day over 24 weeks. Those taking strong CYP2D6 inhibitors will maintain the 24 mg dose throughout. The study involves five visits baseline, 3 weeks, 6 weeks, 12 weeks, and 24 weeks. There is no comparison group instead, responses will be compared to previous research that led to FDA approval. During the study, participants will undergo assessments including the Abnormal Involuntary Movement Scale AIMS, caregiver and clinician global impression scales, and questionnaires measuring activities of daily living, quality of life, caregiver burden, and impact of TD. Researchers will monitor safety, adherence, and treatment effects over the 24-week period. The total involvement includes scheduled visits and evaluations to track changes from baseline through the treatment duration.

Deutetrabenazine Treatment for Tardive Dyskinesia in Intellectual/Developmental Disabilities