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Multiple Therapies for Down Syndrome Regression Disorder
Study Summary
This trial looks at treatments for Down Syndrome Regression Disorder, a condition seen in adolescents and young adults with Down Syndrome that can cause hallucinations, delusions, aggression, and difficulty with daily activities.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am between 8 and 30 years old and have Down syndrome.My tests show I have antibodies in my brain that could cause inflammation.I have not treated my underactive or overactive thyroid.You are allergic or have bad reactions to lorazepam, IVIG, or tofacitinib.I have had blood clots in my veins or arteries.I have not received blood or plasma products in the last 30 days.I haven't taken strong CYP1A2 drugs like phenobarbital or moderate inhibitors like fluvoxamine in the last month.I have had cancer before.I have had Moyamoya syndrome or a stroke.I do not have any significant ongoing or chronic viral infections like HIV or hepatitis.I have an ongoing or untreated bacterial infection.I have a history of acute narrow-angle glaucoma.I haven't used immunosuppressant drugs like adalimumab in the last 6 months.I haven't taken drugs like valproic acid in the last 4 weeks.I agree to stop taking certain medications for my condition during the study.I have previously used methotrexate, cyclophosphamide, or other chemotherapy drugs.I have had brain surgery before.I have heart problems that show symptoms.My kidney function is moderately or severely reduced.I haven't used electroconvulsive therapy, lorazepam, or a JAK inhibitor in the last 4 weeks.I weigh less than 40 kg.You have smoked in the past or currently smoke.I have an IgA deficiency and antibodies against IgA.Participants may be excluded for other unexpected reasons or factors that could make it difficult to understand the symptoms of the kidney disease, based on the study doctor's decision.You have a history of widespread herpes infections or repeated shingles in the same area.I haven't used rituximab in the last 6 months or my B cell levels are above 50 cells/uL.I haven't taken strong drugs like ketoconazole or rifampin in the last month.I have not used IVIG in the last 8 weeks.I have not had any vaccinations in the last 6 weeks and do not plan any during the study.I have a genetic disorder along with my current condition.I haven't taken certain strong medications in the last 4 weeks.I haven't taken specific mood stabilizers or seizure medications in the last 4 weeks.I haven't taken immunosuppressant drugs in the last 8 weeks.I have been diagnosed with a degenerative brain disorder.
- Group 1: Lorazepam
- Group 2: Tofacitinib
- Group 3: Intravenous immunoglobulin (IVIG)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there still opportunities to participate in this research?
"This medical research project, created on June 29th 2023 and last edited the following week, is actively seeking out participants according to information provided by clinicaltrials.gov."
Does the Food and Drug Administration recognize Tofacitinib as a legitimate drug?
"The safety profile of Tofacitinib was classified as a 2 on our internal scale, due to the established evidence for security but lack of data indicating efficacy."
How many participants are currently registered in this trial?
"Affirmative. Clinicaltrials.gov's data indicates that this experiment, which was launched on June 29th 2023, is actively enrolling patients. To complete the study 66 volunteers need to be recruited from two sites."
What are the desired outcomes of this clinical trial?
"The primary aim of this 14-week trial is to ascertain the safety, tolerance and efficacy of lorazepam, IVIG and tofacitinib for individuals suffering from DSRD. Secondary objectives include monitoring changes in family impact scores (PedsQL Family Impact Score), quality of life score (Pediatric Quality Of Life Inventory summary score) and adaptive skills (Vineland Adaptive Behavior Scales-3)."
Who is eligible to join this research endeavor?
"This clinical trial seeks to recruit 66 down syndrome patients aged between eight and thirty. Eligible participants must comply with the following criteria: having one of four types of Down Syndrome, meeting diagnostic guidelines for DSRD, consenting to random treatment assignment, ceasing any medications that may interfere with study interventions, being vaccinated against COVID-19 according to CDC guidance and definitions, and arriving at all visits accompanied by a legal guardian or partner."
Does this trial require participants to be under 50 years of age?
"This trial is designed for individuals aged 8 to 30. For those younger, there are 380 trials available; conversely, over 65s have access to 1003 different clinical trials."
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