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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: Active Phase 2 study of Down Syndrome and Regression, sponsored by University of Colorado, Denver.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A summary of adverse events (AEs) by type and organ system will be reported for the entire study period, along with any statistically significant differences observed in rates of AEs across treatment arms.
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 |
What the registry record for NCT05662228 still lists
NCT05662228 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 2,470-participant average among 54 other Down Syndrome trials with a reported enrollment target (97% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Down Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05662228's enrollment target sits among peer trials
66 29th of 54 higher than 26 of 54 other Down Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Down Syndrome 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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