AD109 for Obstructive Sleep Apnea

Recruiting at 79 trial locations

Overseen By Ron Farkas, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Apnimed

Must not be taking: Sedative-hypnotics

Disqualifiers: Narcolepsy, Insomnia, Cardiac disease, others

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

Duration: 6 months

646 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a Phase 3 Randomized Double-Blind Placebo-Controlled 6-month Parallel-Arm Study to Compare a Fixed Dose Combination of AD109 to Placebo in Obstructive Sleep Apnea.

Eligibility Criteria

This trial is for adults over 18 with Obstructive Sleep Apnea (OSA) who have an AHI of >5, mostly non-central apneas, and low sleep movement-related arousal. Participants should be tired often, not currently using or intolerant to PAP therapy, and have a BMI within set limits.

Inclusion Criteria

PSG criteria: AHI of >5; ≤ 25% central or mixed apneas; and PLM arousal index ≤15

PROMIS-Fatigue: raw score ≥17

My BMI is between 18.5 and 40 (if I am a man) or 42 (if I am a woman).

Exclusion Criteria

I do not have any neuromuscular or neurodegenerative conditions.

I do not have serious heart problems like unstable heart disease or uncontrolled arrhythmias.

I have been diagnosed with narcolepsy, restless leg syndrome, or REM sleep behavior disorder.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a fixed dose combination of AD109 or placebo for 6 months

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• AD109
• Placebo

Trial Overview The study tests AD109 against a placebo in people with OSA. It's a Phase 3 trial where participants are randomly assigned to either the medication or placebo group without knowing which one they're getting. The comparison lasts for six months.

Participant Groups

Group I: AD109 Experimental Treatment 1 Intervention

AD109

Group II: Placebo Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

Apnimed

Lead Sponsor

Trials

17

Recruited

3,400+