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AD109 for Obstructive Sleep Apnea

Verified Trial
Phase 3
Recruiting
Research Sponsored by Apnimed
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥18 years of age at the time of informed consent
PAP intolerance or current PAP refusal
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial tests a drug to treat sleep apnea. It compares the drug to a placebo to see if it's effective.

Who is the study for?
This trial is for adults over 18 with Obstructive Sleep Apnea (OSA) who have an AHI >5, don't respond well to PAP therapy, and feel very tired. They should not be too overweight (BMI limits apply differently for men and women). People with certain sleep disorders, severe heart issues, or significant neurological diseases cannot join.Check my eligibility
What is being tested?
The study tests AD109 against a placebo in people with OSA. It's a year-long test where participants are randomly chosen to receive either the real drug or a fake one without knowing which they're getting. The goal is to see if AD109 helps better than the placebo.See study design
What are the potential side effects?
Since this summary doesn't provide specific side effects of AD109, generally speaking, possible side effects could include typical drug reactions like nausea, headaches, dizziness or allergic responses. However, details would depend on the nature of AD109.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
Select...
I cannot tolerate or refuse to use a CPAP machine.
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My BMI is between 18.5 and 40 (if I am a man) or 42 (if I am a woman).

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy of AD109 on airway obstruction in mild to severe 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

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
13 Previous Clinical Trials
1,395 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the geographic extent of this research study?

"Currently, 4 medical centres are involved in this study. These include Pacific Research Network in San Diego, CTI Clinical Research Center in Cincinnati, and Ohio Sleep Medicine Institute in Dublin."

Answered by AI

Are there open slots available for this research endeavor?

"Clinicaltrials.gov currently affirms that this experiment is seeking participants, with the initial listing posted on August 28th 2023 and a subsequent update occurring September 8th of the same year."

Answered by AI

Has AD109 been granted authorization by the U.S. Food and Drug Administration?

"AD109 has been granted a score of 3, indicating that there is evidence for both its efficacy and safety stemming from past clinical trials."

Answered by AI

What is the cap on enrolment for this clinical experiment?

"Absolutely. As reported on clinicaltrials.gov, the trial launched on August 28th 2023 and is actively recruiting 640 patients at 4 distinct medical facilities. The data was last updated on September 8th of that same year."

Answered by AI

Who else is applying?

What site did they apply to?
Pacific Research Network
Meridian Clinical Research
Research Carolina Elite
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

Ive tried cpap bipap and could not tolerate. cpap doesn't work the way my mouth under bit is.
PatientReceived 1 prior treatment
Uso una maquina para dormir pero me duele mucho mi cabeza. Have had no relief for sleep apnia for year and cannot do CPAP.
PatientReceived 1 prior treatment
I don’t get good sleep wearing my BiPAP mask and would love to try a drug to eliminate this.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Parallel Arm Trial of AD109 and Placebo With Patients With OSA (LunAIRo)
2023. "Parallel Arm Trial of AD109 and Placebo With Patients With OSA (LunAIRo)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05811247.
All > Albuquerque
~396 spots leftby Jun 2025
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