What side effects are associated with this type of intervention?

Atomoxetine, a Selective Norepinephrine Reuptake Inhibitor, commonly causes decreased appetite, nausea, fatigue, and cardiovascular effects such as increased heart rate and blood pressure. Oxybutynin, an Anticholinergic, is known for side effects like dry mouth, constipation, dizziness, and blurred vision. When combined, these medications may result in additive side effects, particularly dry mouth and gastrointestinal discomfort.

What prior FDA approvals exist?

Currently, there are no FDA-approved medications specifically for the treatment of cognitive or behavioral symptoms in individuals with Down Syndrome. However, Atomoxetine, an SNRI, is approved for ADHD, and Oxybutynin, an anticholinergic, is approved for overactive bladder. These drugs are being studied for their potential benefits in treating symptoms associated with Down Syndrome, such as cognitive impairment and obstructive sleep apnea, but they are not yet approved for this specific use.

What other types of research exist?

Promising novel alternatives to Atomoxetine and Oxybutynin for Down Syndrome patients include Guanfacine, a non-stimulant medication used for ADHD, and Mirabegron, a beta-3 adrenergic agonist for overactive bladder. Both have shown efficacy and safety in clinical studies and may offer new treatment options in 2024.

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Atomoxetine + Oxybutynin for Sleep Apnea in Down Syndrome (MOSAIC Trial)

Phase 2

Recruiting

Research Sponsored by University of Arizona

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female participants between 6 to 17 years of age, inclusive, at the Screening Visit

Known diagnosis of Down syndrome (trisomy 21, but not translocation or mosaicism)

Must not have

3+ or greater tonsillar hypertrophy

Seizure disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a combination of two medications, atomoxetine and oxybutynin, in children with Down syndrome and sleep apnea. The goal is to see if these medications can improve their breathing during sleep over several months. The study will measure changes in sleep quality and overall health. Atomoxetine is a nonstimulant medication used for ADHD and generally has fewer negative effects on sleep compared to other treatments.

Who is the study for?

Children aged 6-17 with Down syndrome and obstructive sleep apnea can join this trial. They must have a confirmed diagnosis of trisomy 21 Down syndrome, not due to translocation or mosaicism. Kids with untreated depression, hypothyroidism, severe prematurity, certain heart diseases without clearance, or those on specific medications like MAO inhibitors cannot participate.

What is being tested?

The study tests a combination medication called ato-oxy (atomoxetine and oxybutynin) given before bedtime for six months to see if it improves sleep apnea and cognition in children with Down syndrome. The effectiveness is measured by changes in the number of breathing pauses during sleep from the start to the end of treatment.

What are the potential side effects?

Possible side effects of ato-oxy may include dry mouth, constipation, difficulty urinating, dizziness upon standing up quickly due to low blood pressure (orthostatic hypotension), increased heart rate (tachycardia), and potential mood changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 6 and 17 years old.

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I have been diagnosed with Down syndrome.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My tonsils are significantly enlarged.

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I have a seizure disorder.

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I have depression that I haven't treated yet.

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My thyroid condition is untreated or not well-managed.

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I am taking monoamine oxidase inhibitors.

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I have difficulty emptying my bladder completely.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

obstructive apnea-hypopnea index (oAHI)

Secondary study objectives

Obstructive Sleep Apnea-18 score (OSA-18)

Paired Associates Learning test

Other study objectives

Adaptive function

Arousal Index

Attention Deficit Hyperactivity Disorder symptoms

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Ato-oxyExperimental Treatment1 Intervention

0.5 mg/kg (max 40 mg) atomoxetine and 5 mg oxybutynin

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Atomoxetine, a selective norepinephrine reuptake inhibitor, increases norepinephrine levels in the brain, aiding in the improvement of attention and reduction of hyperactivity, which are common issues in Down Syndrome patients. Oxybutynin, an anticholinergic agent, inhibits acetylcholine on muscarinic receptors, helping manage bladder overactivity, another frequent concern in this population. These treatments are significant as they target specific symptoms associated with Down Syndrome, potentially enhancing cognitive function and overall quality of life.

Pharmacological Treatment of Attention Deficit Hyperactivity Disorder During Pregnancy and Lactation.