Obstructive Sleep Apnea
Conditions
Keywords
sulthiame, obstructive sleep apnea
Brief summary
multi-center, randomized, double-blind, placebo-controlled, dose-finding, 4-arm, parallel assignment study to evaluate the efficacy of three different doses of sulthiame (STM) compared to placebo on sleep apnea activity in adult patients with obstructive sleep apnea.
Detailed description
Primary objective: To evaluate the efficacy of 3 different doses of Sulthiame (STM) compared to placebo on sleep apnea activity in adult patients with moderate to severe obstructive sleep apnea (OSA) after at least 12 weeks of treatment at target dose Secondary objectives: To evaluate the effect of 3 different doses of STM after at least 12 weeks of treatment at target dose in patients with moderate to severe OSA on apnea/hypopnea events, hypoxic burden, sleep quality, daytime sleepiness, patient's perception of symptoms and well-being, comorbidity-related outcomes and safety and tolerability of STM Exploratory objective: To evaluate potential predictive biomarker (eg, blood gas analysis parameters or additional polysomnography \[PSG\] variables) with regard to efficacy
Interventions
DRUGSulthiame
oral
Sponsors
Desitin Arzneimittel GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * OSA diagnosis according to the International Classification of Sleep Disorders - Third Edition criteria with an AHI of ≥15 documented by PSG or polygraphy (PG). * Currently not treated with continuous positive airway pressure (CPAP) or mandibular advancement device (MAD) due to patient-reported: * non-tolerability; and/or * non-compliance; and/or * not willing to use CPAP or MAD (treatment-naïve patients) Key
Exclusion criteria
* Any OSA treatment within the last 4 weeks prior to screening * Fulfill criteria for a dominant central sleep apnea syndrome or dominant Cheyne Stokes respiration * Other clinically significant sleep disorder including periodic limb movement disorder, restless leg syndrome, periodic limb movement arousal index (PLMAI) of \>15\*, insomnia, parasomnia or narcolepsy * as part of PSG baseline assessment * Hypoventilation or hypoxemia due to chronic obstructive pulmonary disease or other respiratory condition * Clinically relevant craniofacial malformation * Any upper airway surgery for OSA within the last 12 months prior to baseline * 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 1 month prior to the first PSG night.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative change in apnea-hypopnea index (AHI) from baseline to Week 15 (at least 12 weeks of treatment at target dose) measured by PSG | from baseline to week 15 | change in apnea-hypopnea index (AHI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number and percentage of patients reporting adverse events, treatment-emergent adverse events (TEAEs) , serious TEAEs, related TEAEs, related serious TEAEs, TEAEs leading to discontinuation of study drug. | from baseline to week 15 | Two-sided 95% confidence intervals for the difference in patient incidence between each sulthiame treatment group and placebo. |
Countries
Belgium
Outcome results
None listed