EUCTR2017-004767-13-SE进行中（未招募）1 期
A randomized, placebo-controlled, multiple dose, double blind, phase IIb, dose guiding trial to explore safety and tolerability of four weeks treatment with sulthiame in patients with moderate to severe obstructive sleep apnea
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 68
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •The patients have to meet all of the following criteria to be eligible to enter the study:
- •1) Provision of informed consent after the scope and nature of the study have been explained prior to any study specific procedures
- •2) Able to speak, read and understand the local language and possess the ability to respond to questions, follow instructions, complete questionnaires and comply with the study procedures
- •3) Male or female gender and aged 18 to 75 years (both inclusive)
- •Female patients
- •A female participant is eligible to participate if she is not pregnant, see Appendix A, not breastfeeding, and if at least one of the following conditions applies:
- •a) Not a woman of childbearing potential (WOCBP) as defined in Appendix A
- •b) A WOCBP who agrees to follow the contraceptive guidance in Appendix A during the treatment period and for at least 4 weeks after the last dose of study drug
- •Male patients
- •A male patient who has not been vasectomized at least 6 months before screening and partners with a WOCBP must be willing to follow the contraceptive guidance in Appendix A during the treatment period and for at least 4 weeks after the last study drug administration.
- •4) BMI =20 kg/m2 and =35 kg/m2
- •5) An AHI of =15 (based on the mean value of 2 sleep studies performed at baseline both with an AHI of =10)
- •6) ESS score =6
- •7) Previous treatment with CPAP that was stopped because of non-acceptance and/or non-tolerability
- •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 76
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Patients meeting any of the following criteria will not be permitted to enter the study:
- •1) Any OSA treatment within the last 4 weeks prior to baseline
- •2) Patients who fulfil criteria for central sleep apnea syndrome or a dominant Cheyne-Stokes respiration or other clinically significant dyssomnia including periodic limb movement disorder, or parasomnia
- •3) Severe nocturnal hypoxia defined as more than 10 episodes with an oxygen desaturation exceeding 50% or signs of lacking resaturation to =90% between desaturations on previous recordings according to the Investigator’s judgment
- •4) Patients with insufficiently treated hypertension (systolic blood pressure =160 mmHg and/or diastolic blood pressure =100 mmHg). If treated, patients must have been on the same dose of antihypertensive medication for at least 4 weeks prior to inclusion
- •5) Clinically stable respiratory failure defined as daytime hypercapnia with arterial pCO2 =6.5 kPa according to medical history
- •6) Type 1 diabetes or insulin treated type 2 diabetes or poorly controlled type 2 diabetes (HbA1c above 42 mmol/mol or 6%)
- •7) Medical history of previously experienced metabolic or respiratory acidosis
- •8) Patient with renal failure or a serum creatinine >130 µmol/L at screening
- •9) Patients with a significant hepatic disease or an ASAT or ALAT >2 times the upper limit of normal at screening
- •10) Patients actively participating in any active weight loss treatment program including any weight loss medication (prescription or over-the-counter) within 2 months prior to Screening
- •11) Patients with a relevant history or a current episode of depression, bipolar disorder, or any other significant psychiatric disorder
- •12) Patients with a history or current suicidal ideation, suicidal behaviour or suicide attempt
- •13) Uncontrolled congestive heart failure
- •14)Myocardial infarction or coronary vessel intervention within the previous 12 months period or unstable angina pectoris
- •15) Previously diagnosed or treated clinically significant cardiac arrhythmia
- •16) Patients previously treated by uvulopalatopharyngoplastic surgery (UPPP) or any other type of surgery for OSA.
- •17) Acute porphyria or untreated hyperthyreosis
- •18) Clinically significant deviation in any screening laboratory measurements or at physical examination as judged by the Investigator
- •19) Allergy/hypersensitivity to the investigational medicinal product (IMP), to chemically related products (e.g. sulfonamides) or to placebo
- •20) History of severe allergy/hypersensitivity or any ongoing allergy/hypersensitivity
- •21) An occupation designated as high risk or safety sensitive including handling complex machinery or professional drivers where there may be an increased risk for work or traffic accidents.
- •22) Patients currently involved in shift-work
- •23) Female patients: currently pregnant or breast-feeding
- •24) Participation in another clinical study during the last 30 days
- •25) Planned surgery during the study period or major surgery within 6 months before first dose
- •26) History of alcohol or drug abuse during the last year
- •27) Patients with a clinically significant gastrointestinal, neurological or haematological disorder or any other significant condition that, in the opinion of the Investigator, could interfere with participation in the study.
研究者
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