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AD109 for Obstructive Sleep Apnea

Phase 3
Waitlist Available
Research Sponsored by Apnimed
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Pivotal Trial

Summary

This trial tests a new sleep apnea treatment compared to a placebo.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects of AD109 aren't detailed here but typically include reactions related to the drug's components or its impact on sleep patterns.

Timeline

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
Efficacy of AD109 on airway obstruction in mild to sever OSA

Side effects data

From 2021 Phase 2 trial • 60 Patients • NCT04580394
4%
Gastroesophageal reflux disease
2%
Cardiac Arrythmia
2%
Headache
2%
Seizure
2%
Atrial Fibrillation
100%
80%
60%
40%
20%
0%
Study treatment Arm
A: AD109
B: Atomoxetine 75 mg + Placebo
C: R-oxybutynin 2.5 mg + Placebo
D:Placebo + Placebo

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AD109Experimental Treatment1 Intervention
AD109
Group II: PlaceboPlacebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AD109
2021
Completed Phase 2
~360

Find a Location

Who is running the clinical trial?

ApnimedLead Sponsor
16 Previous Clinical Trials
2,795 Total Patients Enrolled
~46 spots leftby Feb 2025
Unbiased ResultsWe believe in providing patients with all the options.
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