Measuring Atomoxetine and Aroxybutinin In Patients With OSA

• Status: Not yet recruiting
• Trial end date: 2022-04-01
• Target enrollment: 260
• Participant gender: All

Summary

MARIPOSA is a randomized, double blind, placebo-controlled, parallel-arm 1-month study of AD109 in participants with OSA. Enrolled participants will be randomized to one of 5 parallel treatment arms.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Apnimed
• Treatments: Atomoxetine Hydrochloride

Criteria

Inclusion Criteria:

• Between 18 to 65 years of age for men and 75 for women, inclusive

• AHI between 10 to 45 with <25% events central or mixed apneas

• BMI between 18.5 and 38 kg/m2

Exclusion Criteria:

• Current clinically significant sleep disorder other than OSA

• Clinically significant craniofacial malformation or grade ≥3 tonsillar hypertrophy.

• Clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or hypertension requiring more than 2 drugs for control (combination drugs count as 1 drug).

• Clinically significant neurological disorder, including epilepsy/convulsions.

• History of clinically significant urinary retention, gastric retention or other severe decreased gastrointestinal motility condition

• Severe or frequent gastroesophageal reflux or constipation

• Participants with a history of using devices for OSA treatment, including CPAP, oral or nasal devices, or positional devices, may enroll as long as the devices have not been used for at least 2 weeks prior to first PSG and are not used during participation in the study