NCT04449133已完成2 期
Crossover, Double-blind, Phase 2 Study of AD128 Versus Placebo in Obstructive Sleep Apnea
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Apnea-Hypopnea Index (AHI)
研究概览
简要总结
Obstructive Sleep Apnea (OSA) is the most common and serious of the sleep disorders. Long-term, OSA is associated with increased morbidity and mortality, with a number of adverse cardiovascular, neurocognitive, metabolic, and daytime functioning consequences. No drugs are currently approved for OSA treatment.
This is a randomized, double blind, placebo controlled, cross-over, inpatient phase 2 clinical trial to examine the efficacy and the safety of a fixed dose level of AD128 in patients with OSA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are able to understand the nature of the study and to give free informed consent
- •AHI ≥ 15 on screening/baseline PSG
- •Any of the following conditions should be met:
- •Documented prior PSG within 1 year demonstrating AHI of 15 or higher
- •Documented Continuous Positive Airway Pressure (CPAP) intolerance or poor compliance (compliance is defined as self-reported use of CPAP 4 hours per night for 70% of nights) or CPAP-naïve.
- •Patients who have been using CPAP at least 4 hours nightly for at least 70% of the nights are eligible only if CPAP is not used for 2 weeks prior to the screening/study baseline PSG.
- •Epworth Sleepiness Scale (ESS) score ≥ 4 for patients not using CPAP
- •Previous surgical treatment for OSA is allowed if ≥ 1 year prior to enrollment.
- •BMI between 18.5 and 40.0 kg/m2, inclusive
排除标准
- •History of narcolepsy.
- •Clinically significant craniofacial malformation.
- •Clinically significant cardiac disease or hypertension requiring more than 3 medications for control.
- •Clinically significant neurological disorder, including epilepsy/convulsions
- •History of schizophrenia, schizoaffective disorder or bipolar disorder according to - Diagnostic and Statistical Manual of Mental Disorders-V (DSM V) or International Classification of Disease X edition criteria.
- •History of attempted suicide or suicidal ideation within 1 year prior to screening, or current suicidal ideation.
- •Positive history for abuse of drugs or substance use disorder as defined in DSM-V within 12 months prior to Screening Visit.
- •A significant illness or infection requiring medical treatment in the past 30 days.
- •Clinically significant cognitive dysfunction.
- •Untreated narrow angle glaucoma.
- •Women who are pregnant or nursing.
- •History of using oral or nasal devices for the treatment of OSA may enroll as long as the devices are not used during participation in the study.
- •History of using devices to affect participant sleeping position for the treatment of OSA, e.g. to discourage supine sleeping position, may enroll as long as the devices are not used during participation in the study.
- •History of oxygen therapy.
- •Use of medications from the list of disallowed concomitant medications.
- •Treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors, or monoamine oxidase inhibitors (MAOI) or linezolid within 14 days of the start of treatment, or concomitant with treatment.
- •Use of another investigational agent within 30 days or 5 half-lives, whichever is longer, prior to dosing.
- •Central apnea index > 5/hour on baseline PSG
- •Any condition that in the investigator's opinion would present an unreasonable risk to the participant, or which would interfere with their participation in the study or confound study interpretation.
- •Patients considered by the investigator, for any reason, unsuitable candidates to receive AD128 treatment or unable or unlikely to understand or comply with the dosing schedule or study evaluations.
研究组 & 干预措施
Treatment Group 1
Experimental
AD128 for 7 days, then, after a wash-out period of 7-10 days, placebo for 7 days
干预措施: AD128 (Drug)
Treatment Group 1
Experimental
AD128 for 7 days, then, after a wash-out period of 7-10 days, placebo for 7 days
干预措施: Placebo (Drug)
Treatment Group 2
Experimental
Placebo for 7 days, then, after a wash-out period of 7-10 days, AD128 for 7 days
干预措施: AD128 (Drug)
Treatment Group 2
Experimental
Placebo for 7 days, then, after a wash-out period of 7-10 days, AD128 for 7 days
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Apnea-Hypopnea Index (AHI)
时间窗: From the screening/baseline to the last day of treatment (7 days after the start of each treatment period).
The percentage change of mean AHI will be compared between treatment groups.
次要结局
- Change in Karolinska Sleepiness Scale (KSS)(From screening/baseline to the last day of treatment (7 days after the start of each treatment period).)
- Change in total time with Oxygen Saturation (SaO2) <90%(From screening/baseline to last day of treatment (7 days after the start of each treatment period).)
- Change in minimum SaO2(From screening/baseline to last day of treatment (7 days after the start of each treatment period).)
- Change in Epworth Sleepiness Scale (ESS)(From screening/baseline to the last day of treatment (7 days after the start of each treatment period).)
- Adverse Events (AE)(From screening/baseline to 4 weeks after last day of treatment.)
- AHI decrease ≥50%(From screening/baseline to the last day of treatment (7 days after the start of each treatment period).)
- AHI<15/hour(From screening/baseline to the last day of treatment (7 days after the start of each treatment period).)
- Patient Global Impression of OSA Severity (PGI-S)(From screening/baseline to the last day of treatment (7 days after the start of each treatment period).)
- Change in periodic limb movement(From screening/baseline to last day of treatment (7 days after the start of each treatment period).)
- Change in Psychomotor Vigilance Test (PVT)(From screening/baseline to last day of treatment (7 days after the start of each treatment period).)
- Change in Oxygen Desaturation Index (ODI) 3%(From screening/baseline to last day of treatment (7 days after the start of each treatment period).)
- Change in mean SaO2(From screening/baseline to last day of treatment (7 days after the start of each treatment period).)
- Change in arousal index(From screening/baseline to last day of treatment (7 days after the start of each treatment period).)
- Oxygen Desaturation Index 4%(For the entire at home treatment period: days 1-7 (before crossover) and days 15-20 (after crossover))
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Abu Dhabi Sleep Apnea (ADSA) StudySleep ApnoeaNCT02403141Imperial College London Diabetes Centre1,400
已完成
2 期
Obstructive Sleep Apnea and Telomere LengthObstructive Sleep ApneaNCT04872816Associação Fundo de Incentivo à Pesquisa46
已完成
不适用
OSA-ACS Project: Association of OSA and CPAP Therapy With Outcomes in ACS PatientsObstructive Sleep Apnea of AdultAcute Coronary SyndromeNCT03362385Beijing Anzhen Hospital2,160
已完成
早期 1 期
Evaluatation of Appscent Device Safety and Effectiveness for Relief of Obstructive Sleep Apnea (OSA) Syndrome in Adults.Obstructive Sleep ApneaNCT04609618Y.A. Appscent Ltd.23
尚未招募
不适用
Study Evaluating the Effect of a Specific Trace Metal Complex Versus Placebo on the Severity of Apnea in Patients With Obstructive Sleep Apnea SyndromeApnea, ObstructiveNCT05758324Laboratoires Pronutri42