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NCT05662228 · ClinicalTrials.gov registry record · Phase 2
Therapies for Down Syndrome Regression Disorder
A Phase 2 study of Down Syndrome and Regression, sponsored by University of Colorado, Denver.
- Active
- Registry status
- Phase 2
- Development phase
- 66
- Enrollment target
- 2
- Study locations
NCT05662228 is a Phase 2 study of Down Syndrome and Regression that is active but no longer recruiting, run by University of Colorado, Denver. The registered enrollment target is 66 participants, below the 2,470-participant average among 54 other Down Syndrome trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT05662228, a Phase 2 study of Down Syndrome and Regression, is active but no longer recruiting, sponsored by University of Colorado, Denver.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 66 participants
- Enrollment target
- 2
- Study locations
Study Summary
Individuals with Down syndrome (DS) have an increased risk of numerous co-occurring conditions, including the neuropsychiatric condition known as Down Syndrome Regression Disorder (DSRD). A DSRD diagnosis often includes a sub-acute onset of catatonia, mutism, depersonalization, loss of ability to perform activities of daily living, hallucinations, delusions, and aggression and is most commonly observed in adolescents and young adults. The study evaluates the safety and efficacy of three currently prescribed therapies: lorazepam, intravenous immunoglobulin (IVIG) and tofacitinib.
Conditions Studied
Interventions
- DRUG Tofacitinib
- DRUG Lorazepam
- DRUG Intravenous immunoglobulin (IVIG)
Study Locations (2)
California
- Children's Hospital Los Angeles - Los Angeles
Colorado
- Children's Hospital Colorado - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2023-06-29 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05662228
The ClinicalTrials.gov registry entry for NCT05662228 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,470-participant average among 54 other Down Syndrome trials with a reported enrollment target (97% lower). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Down Syndrome appearing as the primary indexed condition, and to 3 interventions - of which Tofacitinib is the first listed.
NCT05662228 reports 2 study locations spanning 2 distinct geographic areas - top geographies include California, Colorado.
Frequently Asked Questions
What is clinical trial NCT05662228 about?
NCT05662228 is a clinical study titled "Therapies for Down Syndrome Regression Disorder". Individuals with Down syndrome (DS) have an increased risk of numerous co-occurring conditions, including the neuropsychiatric condition known as Down Syndrome Regression Disorder (DSRD). A DSRD diagnosis often includes a sub-acute onset of catatonia, mutism, depersonalization, loss of ability to pe...
What is the current status of trial NCT05662228?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2023-06-29. Estimated completion is 2026-12.
What conditions does trial NCT05662228 study?
This clinical trial studies the following conditions: Down Syndrome, Regression.
What interventions are being tested in trial NCT05662228?
The interventions under investigation include: Tofacitinib (DRUG), Lorazepam (DRUG), Intravenous immunoglobulin (IVIG) (DRUG).
Who is sponsoring clinical trial NCT05662228?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05662228 being conducted?
This trial has 2 study locations across California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.