A placebo-controlled, multiple dose, 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
- Conditions
- Moderate to severe obstructive sleep apneaMedDRA version: 20.0Level: LLTClassification code 10055577Term: Obstructive sleep apnea syndromeSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2017-004767-13-SE
- Lead Sponsor
- Desitin Arzneimittel GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 68
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
OR
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method