drugset / Trial / NCT05662228
Therapies for Down Syndrome Regression Disorder
Phase 2
Completed
66 enrolled
University of Colorado, Denver
Children's Hospital Los Angeles · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2023-06-29
- Primary completion
- 2026-05-05
- Completion
- 2026-05-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 1 mg/kg | Intravenous |
| Subject | Lorazepam | Small molecule | 2 mg | Oral |
| Subject | Tofacitinib | Small molecule | 5 mg | Oral |