Efficacy, Safety and Tolerability of Three Doses of Sulthiame in Patients With Obstructive Sleep Apnea.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 298
- 试验地点
- 1
- 主要终点
- Relative change in apnea-hypopnea index (AHI) from baseline to Week 15 (at least 12 weeks of treatment at target dose) measured by PSG
研究概览
简要总结
multi-center, randomized, double-blind, placebo-controlled, dose-finding, 4-arm, parallel assignment study to evaluate the efficacy of three different doses of sulthiame (STM) compared to placebo on sleep apnea activity in adult patients with obstructive sleep apnea.
详细描述
Primary objective: To evaluate the efficacy of 3 different doses of Sulthiame (STM) compared to placebo on sleep apnea activity in adult patients with moderate to severe obstructive sleep apnea (OSA) after at least 12 weeks of treatment at target dose
Secondary objectives: To evaluate the effect of 3 different doses of STM after at least 12 weeks of treatment at target dose in patients with moderate to severe OSA on apnea/hypopnea events, hypoxic burden, sleep quality, daytime sleepiness, patient's perception of symptoms and well-being, comorbidity-related outcomes and safety and tolerability of STM
Exploratory objective: To evaluate potential predictive biomarker (eg, blood gas analysis parameters or additional polysomnography [PSG] variables) with regard to efficacy
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
- Double (Participant, Investigator)
盲法说明
placebo
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •OSA diagnosis according to the International Classification of Sleep Disorders - Third Edition criteria with an AHI of ≥15 documented by PSG or polygraphy (PG).
- •Currently not treated with continuous positive airway pressure (CPAP) or mandibular advancement device (MAD) due to patient-reported:
- •non-tolerability; and/or
- •non-compliance; and/or
- •not willing to use CPAP or MAD (treatment-naïve patients)
排除标准
- •Any OSA treatment within the last 4 weeks prior to screening
- •Fulfill criteria for a dominant central sleep apnea syndrome or dominant Cheyne Stokes respiration
- •Other clinically significant sleep disorder including periodic limb movement disorder, restless leg syndrome, periodic limb movement arousal index (PLMAI) of >15*, insomnia, parasomnia or narcolepsy
- •as part of PSG baseline assessment
- •Hypoventilation or hypoxemia due to chronic obstructive pulmonary disease or other respiratory condition
- •Clinically relevant craniofacial malformation
- •Any upper airway surgery for OSA within the last 12 months prior to baseline
- •Patients who underwent an obesity surgery within the last 2 years prior to baseline or patients actively participating in any weight loss treatment program or use of any weight loss medication (prescription or over-the-counter) within 1 month prior to the first PSG night.
研究组 & 干预措施
Sulthiame 100 mg
Sulthiame film-coated tablets 100 mg once daily 15 weeks
干预措施: Sulthiame (Drug)
Sulthiame 200 mg
Sulthiame film-coated tablets 200 mg once daily 15 weeks
干预措施: Sulthiame (Drug)
Sulthiame 300 mg
Sulthiame film-coated tablets 300 mg once daily 15 weeks
干预措施: Sulthiame (Drug)
Placebo
Placebo film-coated tablets once daily 15 weeks
干预措施: Sulthiame (Drug)
结局指标
主要结局
Relative change in apnea-hypopnea index (AHI) from baseline to Week 15 (at least 12 weeks of treatment at target dose) measured by PSG
时间窗: from baseline to week 15
change in apnea-hypopnea index (AHI)
次要结局
- Number and percentage of patients reporting adverse events, treatment-emergent adverse events (TEAEs) , serious TEAEs, related TEAEs, related serious TEAEs, TEAEs leading to discontinuation of study drug.(from baseline to week 15)