The trial is taking place at:
E

Empire Clinical Research | Pomona, CA

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Parallel Arm Trial of AD109 and Placebo With Patients With OSA (LunAIRo)

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Apnimed

Status and phase

Active, not recruiting
Phase 3

Conditions

OSA

Treatments

Drug: Placebo
Drug: AD109

Study type

Interventional

Funder types

Industry

Identifiers

NCT05811247
APC-APN-304

Details and patient eligibility

About

This is a Phase 3 Randomized Double-Blind Placebo-Controlled 1-year Parallel-Arm Study to Compare a Fixed Dose Combination of AD109 to Placebo in Obstructive Sleep Apnea.

Enrollment

660 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • ≥18 years of age at the time of informed consent.
  • PSG criteria: AHI of >5; ≤ 25% central or mixed apneas; and PLM arousal index ≤15
  • PROMIS-Fatigue: raw score ≥17
  • PAP intolerance or current PAP refusal.
  • BMI between 18.5 and 40 kg/m2 for men, or 42 kg/m2 for women, inclusive.

Exclusion criteria

  • Narcolepsy, restless leg syndrome, REM sleep behavior disorder
  • Insomnia disorder characterized by difficulty initiating or maintaining sleep, or use within the past month of sedative-hypnotics or other medication for the purpose of treating or avoiding insomnia symptoms.
  • Pierre Robin, Treacher Collins, or other craniofacial malformation syndrome, or grade ≥3 tonsillar hypertrophy.
  • Clinically significant cardiac disease, e.g., ventricular arrhythmia, untreated or unstable coronary artery disease, cardiac failure. Stable atrial arrhythmia is allowed.
  • Neuromuscular disorder (e.g., motor neuron disease, muscular dystrophy or myopathy, myasthenic syndrome); epilepsy; Parkinson, Alzheimer, or other neurodegenerative disease.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

660 participants in 2 patient groups, including a placebo group

AD109
Experimental group
Description:
AD109
Treatment:
Drug: AD109
Placebo
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: Placebo

Trial contacts and locations

64

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Central trial contact

Ron Farkas, MD; Luigi Taranto, MD

Data sourced from clinicaltrials.gov

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