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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 is a Phase 4 study that is actively recruiting participants, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 25 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06997198
The ClinicalTrials.gov registry entry for NCT06997198 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University Hospitals Cleveland Medical Center, which has 230 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Deutetrabenazine Oral Capsule is the first listed.
NCT06997198 reports 0 study locations.
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.
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