EUCTR2021-002926-26-BE进行中（未招募）1 期
Efficacy, Safety and Tolerability of 3 doses of Sulthiame in Patients with Obstructive Sleep Apnea. A Randomized, Double-Blind, Placebo Controlled, Dose-Ranging Study
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 368
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Willing and able to provide written informed consent
- •2. Male or female aged 18 to 75 years inclusive
- •3. OSA diagnosis according to the international classification of sleep disorders (ICSD)-3 criteria with an AHI =15 documented by PSG or polygraphy (PG)
- •4. Currently not treated with CPAP or MAD (see further details in the protocol)
- •5. An AHI of =15 to =50 (mean from 2 PSG recordings [2 nights] at baseline), AHI of at least 10 on each night
- •6. BMI =18.5 kg/m2 and =35 kg/m2
- •7. Women of childbearing potential (WOCBP) or men whose sexual partners are WOCBP must be able and willing to use at least 1 highly effective method of contraception for at least 2 months prior to the first dose of study drug, throughout the entire study period, and for 30 days after the last dose of study drug
- •8. Willing and able to comply with the study design schedule and other requirements
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 220
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 148
排除标准
- •1. Any OSA treatment within the last 4 weeks prior to screening
- •2. Fulfilling criteria for a dominant central sleep apnea syndrome or a dominant Cheyne Stokes respiration
- •3. Other clinically significant sleep disorder including periodic limb movement disorder, restless leg syndrome, periodic limb movements arousal index (PLMAI) >15, insomnia, parasomnia or narcolepsy
- •4. Hypoventilation or hypoxemia due to chronic obstructive pulmonary disease or other respiratory condition
- •5. Clinically relevant craniofacial malformation
- •6. Any upper airway surgery for OSA within the last 12 months prior to baseline
- •7. 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 2 months prior to the first PSG night
- •8. Elevated blood pressure or uncontrolled hypertension (systolic blood pressure =160 mm Hg and/or diastolic blood pressure =100 mm Hg). If treated, patients must have been on the same dose of antihypertensive medication for at least 4 weeks prior to screening
- •9. Uncontrolled congestive heart failure
- •10. Myocardial infarction or coronary vessel intervention within the previous 6 months period or unstable angina pectoris
- •11. Previously diagnosed or treated clinically significant cardiac arrhythmia
- •12. Episode of major depression, bipolar disorder, or any other significant psychiatric disorder within the last 12 months prior to screening
- •13. Significant neurological or cognitive disorders as detailed in the protocol
- •14. Renal or hepatic failure as defined in the protocol
- •15. History of severe allergy/hypersensitivity or any ongoing allergy/hypersensitivity requiring continuous medical treatment
- •16. Known allergy/hypersensitivity to STM and ingredients or to sulfonamides
- •17. Nightshift-workers, professional drivers, patients handling complex machinery or with any other occupation where there may be an increased risk for work or traffic accidents
- •18. Participation in another clinical study during the last 30 days prior to screening
- •19. Planned surgery during the study period or major surgery within 6 months prior to first dose of study drug
- •20. History of alcohol or drug abuse during the last year, substance use disorder, positive urine drug screen for drugs of abuse at screening
- •21. Intake of any protocol-specified prohibited medication
- •22. Clinically significant gastrointestinal, metabolic, urinary, or hematological disorder or any other significant condition or infection that, in the opinion of the investigator, could interfere with participation in the study. Note, acute porphyria and untreated hyperthyroidism are excluded.
- •23. Type 1 diabetes or insulin treated type 2 diabetes or poorly controlled type 2 diabetes
- •24. Positive COVID-19 polymerase chain reaction (PCR) test result within 30 days prior to screening, history of hospitalization for COVID-19 within 30 days prior to screening, or history of use of oxygen due to COVID-19 within 30 days prior to screening. Note that previous COVID-19 infection alone is not exclusionary and vaccination against SARS-CoV-2 is allowed, but must be documented.
- •25. Planned COVID-19 vaccination during the trial participation or within 2 weeks prior to screening. Booster vaccinations are allowed.
- •26. History of actual suicidal behavior or suicidal ideation of type 2 to 5 within one year prior to screening, or current suicida
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