NCT04580394

Crossover Trial of AD109 in Obstructive Sleep Apnea

Phase 2 Randomized Double-Blind Placebo-Controlled 4-Period Single-Dose Crossover Factorial Study to Evaluate the Contribution of the Individual Drug Components to the Efficacy of AD109 in Obstructive Sleep Apnea

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Apnimed · Industry
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, 4-period, placebo-controlled, crossover, phase 2 clinical study to examine the efficacy and safety of AD109 versus its individual components or placebo in patients with obstructive sleep apnea.

Detailed description

The study is designed to examine the efficacy and safety of AD109 to treat obstructive sleep apnea. The study is a four-period single-dose randomized crossover design in which patients will undergo overnight polysomnographic (PSG) testing with dosing of one of the following 4 treatments: AD109, atomoxetine, R-oxybutynin or placebo. Participants will return 2 weeks after their final crossover PSG for an end of study (EOS) visit.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DRUG	AD109	Oral administration before bed
DRUG	Atomoxetine	Oral administration before bed
DRUG	R-oxybutynin	Oral administration before bed
DRUG	Placebo	Oral administration before bed
DIAGNOSTIC_TEST	Digit System Substitution Test	a neuropsychological test sensitive to brain damage, dementia, age and depression where numbers are assigned symbols. Under each digit the subject should write down the corresponding symbol as fast as possible. The number of correct symbols within the allowed time is measured.

Timeline

• Start date: 2020-10-27
• Primary completion: 2021-05-28
• Completion: 2021-05-28
• First posted: 2020-10-08
• Last updated: 2023-01-31
• Results posted: 2023-01-31

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study