Efficacy, Safety and Tolerability of Sulthiame in Patients with Obstructive Sleep Apnea

Phase 1

• Conditions: Obstructive sleep apnea; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]; MedDRA version: 25.0Level: LLTClassification code 10055577Term: Obstructive sleep apnea syndromeSystem Organ Class: 100000004855

• Registration Number: EUCTR2021-002926-26-CZ
• Lead Sponsor: Desitin Arzneimittel GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-15
• Last Update Posted: 3 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 368

Inclusion Criteria

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

Exclusion Criteria

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 suicidal id

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified