None listed
Conditions
Brief summary
The purpose of this study is to investigate the longer-term tolerability and efficacy (treatment effect) of the drug combination known as AD036 at standard doses over an approximately 30 day period. This study will also include lower doses of AD036 that have not been studied previously. We know from previous studies that single standard doses of the combination of AD036 reduces sleep apnoea severity. Thus, these findings are expected to provide guidance on the ideal dose and a deeper understanding on the safety and tolerability of the use of these medicines in people with sleep apnoea.
Interventions
4 Arms:
Group 1: AD036 single dose of drug combination (80mg/5mg) nightly for 30 days (oral capsule)
Group 2: AD036 single dose of drug combination (40mg/5mg) nightly for 30 days (oral capsule)
Group 3: AD036 single dose of drug combination (40mg/2.5mg) nightly for 30 days (oral capsule)
Group 4: Placebo pill nightly for 30 days (oral capsule)
First night of medication to be administered in-laboratory. Weekly telephone calls by the researcher to ensure participant adherence. Last night of trea
4 Arms: Group 1: AD036 single dose of drug combination (80mg/5mg) nightly for 30 days (oral capsule) Group 2: AD036 single dose of drug combination (40mg/5mg) nightly for 30 days (oral capsule) Group 3: AD036 single dose of drug combination (40mg/2.5mg) nightly for 30 days (oral capsule) Group 4: Placebo pill nightly for 30 days (oral capsule) First night of medication to be administered in-laboratory. Weekly telephone calls by the researcher to ensure participant adherence. Last night of treatment to be administered in-laboratory.
Sponsors
Flinders University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Participants documented PSG within 1 year demonstrating AHI of 15 or higher. Documented CPAP intolerance or poor compliance or CPAP naive. Participants using CPAP at least 4 hours nightly are eligible for further screening and baseline PSG. Previous surgical airway treatment for OSA allowed if more than 1 year prior to enrollment. If male, International Prostate Symptom Score (IPSS) must be less than 15. BMI between 18.5 and 40 kg/m^2.
Exclusion criteria
1. History of narcolepsy. 2. Clinically significant craniofacial malformation. 3. Clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or hypertension requiring more than 2 medications for control. 4. Clinically significant neurological disorder, including epilepsy/convulsions. 5. History of schizophrenia, schizoaffective disorder or bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders-V (DSM V) or International Classification of Disease tenth edition criteria. 6. History of attempted suicide or suicidal ideation within 1 year prior to screening, or current suicidal ideation. 7. History of clinically significant constipation, gastric retention, or urinary retention. 8. History of drug abuse or substance use disorder as defined in DSM-V within 12 months prior to Screening Visit. 9. A significant acute illness or infection requiring medical treatment in the past 30 days. 10. Clinically significant cognitive dysfunction. 11. Untreated narrow angle glaucoma. 12. Women who are pregnant or nursing. Prior/Concomitant Therapy 13. History of using oral or nasal devices for the treatment of OSA may enroll as long as the devices are not used during participation in the study. 14. History of using devices to affect participant sleeping position for the treatment of OSA, e.g. to discourage supine sleeping position, may enroll as long as the devices are not used during participation in the study. 15. History of oxygen therapy. 16. Use of medications from the list of disallowed concomitant medications. 17. Treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors, strong cytochrome P450 2D6 (CYP2D6) inhibitors, or monoamine oxidase inhibitors (MAOI) within 14 days of the start of treatment, or concomitant with treatment. Prior/Concurrent Clinical Study Experience 18. Use of another investigational agent within 30 days or 5 half-lives, whichever is longer, prior to dosing. Diagnostic Assessments 19. ESS total score > 18. 20. Central apnea index > 5/hour on baseline PSG. 21. Periodic limb movement arousal index >15/hour on baseline PSG. Other Exclusions 22. <5 hours typical sleep duration. 23. Night- or shift-work sleep schedule. 24. Employment as a commercial driver or operator of heavy or hazardous equipment. 25. Smoking more than 10 cigarettes or 2 cigars per day. 26. Unwilling to use specified contraception. 27. Unwilling to limit alcohol consumption to no greater than 2 units/day or less, not to be consumed within 3 hours of bedtime. 28. Unwilling to limit caffeinated beverage intake (e.g., coffee, cola, tea) to 400 mg/day or less of caffeine, not to be used within 3 hours of bedtime. 29. Any condition that in the investigator’s opinion would present an unreasonable risk to the participant, or which would interfere with their participation in the study or confound study interpretation. 30. Participant considered by the investigator, for any reason, an unsuitable candidate to receive AD036 or unable or unlikely to understand or comply with the dosing schedule or study evaluations.
Outcome results
None listed