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NCT06997198 · ClinicalTrials.gov registry record · Phase 4
Deutetrabenazine Treatment for Tardive Dyskinesia in Intellectual/Developmental Disabilities
A Phase 4 study, sponsored by University Hospitals Cleveland Medical Center.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 25
- Enrollment target
NCT06997198: Recruiting Phase 4 study, sponsored by University Hospitals Cleveland Medical Center.
NCT06997198 is a Phase 4 study that is actively recruiting participants, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 25 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06997198, a Phase 4 study, is actively recruiting participants, sponsored by University Hospitals Cleveland Medical Center.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 25 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The Abnormal Involuntary Movement Scale (AIMS) has been used for many years as the gold standard for this purpose and the amount of improvement (change in movement intensity, and reduction in AIMS scores) have been assessed clinical significance in rating improvement. A number of authors have noted the difficulty in using the AIMS in persons with IDD who cannot cooperate fully in the examination process. For this reason, some have suggested using videotaped AIMS exams as a methodology for more a
Interventions
- DRUG Deutetrabenazine Oral Capsule
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2026-06-22 |
| Est. Completion | 2027-10-01 |
| Phase | Phase 4 |
What NCT06997198 shows while recruiting
NCT06997198 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Deutetrabenazine Oral Capsule is the first listed.
NCT06997198 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06997198 about?
NCT06997198 is a clinical study titled "Deutetrabenazine Treatment for Tardive Dyskinesia in Intellectual/Developmental Disabilities". 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 ...
What is the current status of trial NCT06997198?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 25 participants. The study started on 2026-06-22. Estimated completion is 2027-10-01.
What interventions are being tested in trial NCT06997198?
The interventions under investigation include: Deutetrabenazine Oral Capsule (DRUG).
Who is sponsoring clinical trial NCT06997198?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06997198's enrollment target sits among peer trials
25 1669th of 2000 higher than 302 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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