NCT05813275已完成3 期
Phase 3 Randomized Double-Blind Placebo-Controlled 6-month Parallel-Arm Study to Compare a Fixed Dose Combination of Aroxybutynin/Atomoxetine (AD109) to Placebo in Obstructive Sleep Apnea (SynAIRgy Study)
Apnimed146 个研究点 分布在 1 个国家目标入组 646 人开始时间: 2023年9月16日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 646
- 试验地点
- 146
- 主要终点
- Change From Baseline in Apnea-Hypopnea Index (AHI)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age at the time of informed consent.
- •PSG criteria: AHI of ≥10 and ≤45; ≤ 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.
排除标准
- •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.
- •Exclusion Criteria:
研究组 & 干预措施
AD109
Experimental
干预措施: AD109 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Apnea-Hypopnea Index (AHI)
时间窗: 6 months
AHI, Apnea-Hypopnea Index, is the number of apneas or hypopneas recorded via polysomnography during the study per hour of sleep. Apnea is defined as a cessation of airflow lasting at least 10 seconds, hypopnea as a decrease in airflow by at least 30% from baseline for at least 10 seconds occurring with a drop in oxygen saturation (SpO2) by at least 4%.
Change from Baseline in Apnea-Hypopnea Index (AHI)
时间窗: 6 months
AHI, Apnea-Hypopnea Index, is the number of apneas or hypopneas recorded via polysomnography during the study per hour of sleep. Apnea is defined as a cessation of airflow lasting at least 10 seconds, hypopnea as a decrease in airflow by at least 30% from baseline for at least 10 seconds occurring with a drop in oxygen saturation (SpO2) by at least 4%.
次要结局
未报告次要终点
研究者
研究点 (146)
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• Tolebrutinib shows promise in slowing disability progression in non-relapsing secondary progressive multiple sclerosis patients in the HERCULES trial.last yearApnimed's AD109 Phase 3 Trial for Obstructive Sleep Apnea Completes Enrollment- Apnimed has completed enrollment for its Phase 3 SynAIRgy study evaluating AD109, a potential oral treatment for obstructive sleep apnea (OSA).
- The SynAIRgy study assesses the efficacy and safety of AD109 compared to placebo over six months in adults with mild, moderate, and severe OSA.
- AD109 targets the neuromuscular dysfunction underlying OSA, potentially offering a novel approach to improve oxygenation during sleep.
- Topline Phase 3 data from both the SynAIRgy and LunAIRo studies of AD109 are expected in mid-2025.last yearAD109 Advances to Phase III Trials as First Oral Therapy for Obstructive Sleep Apnea- AD109, a combination of aroxybutynin and atomoxetine, represents the first oral pharmacologic therapy targeting neurological pathways to activate upper airway dilator muscles in obstructive sleep apnea.
- Phase II MARIPOSA trial demonstrated significant efficacy with 77% of mild OSA patients achieving AHI scores below 10, while 42% of moderate cases reached this threshold.
- The ongoing SynAIRgy Phase III trial is enrolling 640 participants who cannot tolerate CPAP therapy, with primary endpoint measuring 50% reduction in apnea-hypopnea index over 26 weeks.
- Treatment showed statistically significant improvements in daytime fatigue and was well-tolerated with no serious adverse events in earlier trials.2 years ago