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

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

1. ≥18 years of age at the time of informed consent.
2. PSG criteria: AHI of >5; ≤ 25% central or mixed apneas; and PLM arousal index ≤15
3. PROMIS-Fatigue: raw score ≥17
4. PAP intolerance or current PAP refusal.
5. BMI between 18.5 and 40 kg/m2 for men, or 42 kg/m2 for women, inclusive.

Exclusion criteria

1. Narcolepsy, restless leg syndrome, REM sleep behavior disorder
2. 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.
3. Pierre Robin, Treacher Collins, or other craniofacial malformation syndrome, or grade ≥3 tonsillar hypertrophy.
4. Clinically significant cardiac disease, e.g., ventricular arrhythmia, untreated or unstable coronary artery disease, cardiac failure. Stable atrial arrhythmia is allowed.
5. 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

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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