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Deutetrabenazine Treatment for Tardive Dyskinesia in Intellectual/Developmental Disabilities

Study acronym: TD-AIDD
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened
    • Start date changed from estimate of May 1, 2026 to Jun 22, 2026
    • Site details revised
    v7
  2. Start date: Mar 1, 2026 to May 1, 2026v6
  3. Start date: Dec 15, 2025 to Mar 1, 2026v5
  4. Start date: Nov 1, 2025 to Dec 15, 2025v4
  5. Start date: Sep 1, 2025 to Nov 1, 2025v3
  6. Start date: Jul 1, 2025 to Sep 1, 2025
    • Primary and study completion dates: Aug 1, 2027 to Oct 1, 2027
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The primary goal of this study is to investigate the efficacy of deutetrabenazine treatment of TD in this previously untreated patient population. Compare movement disorder deutetrabenazine treatment response in persons with IDD to response seen in patients without IDD treated with deutetrabenazine in other treatment settings (per literature review). Compare global deutetrabenazine treatment response with validated instruments. In addition, we plan to: * Assess the safety of deutetrabenazine in the treatment of TD in persons with IDD. * Assess change in Activities of Daily Living (ADLs) in persons with IDD and TD treated with deutetrabenazine, utilizing a validated ADL instrument. * Assess change in Quality of Life (QOL) in persons with IDD and TD treated with deutetrabenazine, utilizing a validated QOL instrument. * Assess caregiver burden with a validated caregiver burden instrument. In this study, 25 participants with IDD and TD will undergo Deutetrabenazine 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 deutetrabenazine treatment with those from a previous reported work that resulted in the FDA approval of this medication. This will be an open-label, Phase 4 study.
Trial Details
NCT Number NCT06997198
Lead Sponsor University Hospitals Cleveland Medical Center
Collaborators: Teva Pharmaceuticals USA
Conditions
(from sponsor)		 Tardive Dyskinesia, Intellectual Disability, Developmental Disabilities
Related terms Caregiver Burden, Developmental Disabilities, Intellectual Disability, Movement Disorders, Tardive Dyskinesia
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov