Clinical trialNCT05662228CompletedPhase 2Interventional

Therapies for Down Syndrome Regression Disorder

SponsorUniversity of Colorado, DenverEnrollment66Down SyndromeRegression

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Elise Sannar, MD
Children's Hospital Colorado
Principal Investigator
clinicaltrials.gov ↗
Joaquin Espinosa, PhD
Linda Crnic Institute for Down Syndrome
Principal Investigator
clinicaltrials.gov ↗
Jonathon Santoro, MD
Children's Hospital Los Angeles
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

2 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Children'S Hospital Los Angeles
Los Angeles, California, United States
Children'S Hospital Colorado
Aurora, Colorado, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Intravenous immunoglobulinLorazepam →Tofacitinib →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 29 Jun 2023
Primary completion: 5 May 2026
Completion: 28 May 2026
Last update posted: 13 Jul 2026
Registered enrollment: 66
Registry id: NCT05662228

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.