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The trial is taking place at:
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Epic Medical Research | Red Oak, TX

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Parallel-Arm Study to Compare AD109 to Placebo With Patients With OSA (SynAIRgy Study)

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Apnimed

Status and phase

Enrolling
Phase 3

Conditions

OSA

Treatments

Drug: Placebo
Drug: AD109

Study type

Interventional

Funder types

Industry

Identifiers

NCT05813275
APC-APN-305

Details and patient eligibility

About

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.

Enrollment

740 estimated 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 ≥10 and ≤45; ≤ 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.

Exclusion Criteria:

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

740 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

73

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Central trial contact

Ron Farkas, MD; Luigi Taranto, MD

Data sourced from clinicaltrials.gov

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