AD109 for Obstructive Sleep Apnea

Recruiting at 99 trial locations

Overseen By Luigi Taranto, MD, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Apnimed

Disqualifiers: Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

1280 Participants Needed

Trial Summary

What is the purpose of this trial?

The combination drug composed of aroxybutynin and atomoxetine, designated AD109, is being developed by Apnimed for the treatment of obstructive sleep apnea (OSA). The present study is a Phase 3 open label continuation protocol enrolling qualifying participants who completed one of the parent Phase 3 double-blind placebo-controlled studies, APC-APN-304 or APC-APN-305.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, the investigator will decide if your current medications make participation unsafe.

Research Team

Ron Farkas, MD

Principal Investigator

Apnimed

Eligibility Criteria

This trial is for individuals who have completed one of the parent Phase 3 studies, APC-APN-304 or APC-APN-305, and are diagnosed with obstructive sleep apnea (OSA). Specific eligibility details are not provided but typically include meeting certain health standards.

Inclusion Criteria

Completion of APC-APN-304 without permanent discontinuation of IMP

Completion of APC-APN-305 without permanent discontinuation of IMP

Exclusion Criteria

Participants are excluded from the study if participation would be considered unsafe by the investigator based on the individual's current status

Participants are excluded from the study if participation would be considered unsafe by the investigator based on concomitant therapies.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open-label Treatment

Participants receive the combination drug AD109 in an open-label format

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• AD109

Trial Overview The study tests a combination drug called AD109, made up of aroxybutynin and atomoxetine. It's an open label continuation from previous double-blind studies aimed at treating OSA in those who've already participated.

Participant Groups

Group I: AD109 Experimental Treatment 1 Intervention

Open Label AD109

Who Is Running the Clinical Trial?

Apnimed

Lead Sponsor

Trials

17

Recruited

3,400+