Moderate to severe obstructive sleep apnea MedDRA version: 20.0 Level: LLT Classification code 10055577 Term: Obstructive sleep apnea syndrome System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Ospolot 50 mg film-coated tablet
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: SULTIAME
CAS Number: 61-56-3
Concentration unit: mg milligram(s)
Concentration type: equal
Con
Sponsors
Desitin Arzneimittel GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to explore the safety and tolerability of 4 weeks of treatment with different doses of sulthiame (STM) in patients with obstructive sleep apnea (OSA).;Secondary Objective: Secondary objectives of the study are to explore the efficacy of 4 weeks of treatment with STM: • on sleep apnea activity (change in AHI from baseline measured by polysomnography [PSG]) • on other sleep related variables measured by PSG, including calculated and estimated measures of sleep apnea reduction • on patient-reported outcomes (PROs) including health related quality of life (HRQoL) • on investigator-reported patient outcomes (global impression) • on psychomotor vigilance test (PVT) • on biomarkers;Primary end point(s): • AEs including serious adverse events (SAEs) and adverse events of special interest (AESI) (i.e. clinically relevant change in blood pressure, ECG verified cardiac ischemia [referring to “stenocardia” specified as adverse reaction in the Summary of Product Characteristics (SmPC)], and tachycardia [resting heart rate >100/min]) • Resting blood pressure (systolic, diastolic, and mean arterial pressure [MAP]), pulse, respiratory rate, and vascular stiffness • BW, BMI, and waist and hip circumference ratio • Laboratory parameters (clinical chemistry, haematology, and urinalysis) • Lipid panel, glycemic variables, and venous blood gas panel • ECG;Timepoint(s) of evaluation of this end point: Please refer to flow chart in Clinical Study Protocol | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • PSG: - Change from baseline to Week 4 in AHI - Change from baseline to Week 4 in Oxygen Desaturation Index 4% (ODI, 4%) • Change from baseline in PROs and investigator-reported patient outcomes - ESS - Clinical Global Impression Scale rating Severity and Improvement (CGI-S and CGI-I) - Patient Global Impression Scale rating Severity and Improvement (PGI-S and PGI-I) - Functional Outcomes of Sleep Questionnaire (FOSQ) - 36-Item Short-Form Health Survey (SF-36) • Change from baseline in PVT;Timepoint(s) of evaluation of this end point: Please refer to flow chart in Clinical Study Protocol | — |
Countries
Sweden
Contacts
Public ContactProfessor Jan Hedner
University of Gothenburg - Centre for sleep and waking disorders
Outcome results
None listed