Efficacy, Safety and Tolerability of Sulthiame in Patients With Obstructive Sleep Apnea (OSA)

Study Overview
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Brief Summary
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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
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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

Official Title
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Efficacy, Safety and Tolerability of Three Doses of Sulthiame in Patients With Obstructive Sleep Apnea.

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Drug: Sulthiame


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sulthiame 100 mg<br>Sulthiame film-coated tablets 100 mg once daily 15 weeks | Drug: Sulthiame<br>* oral<br>* Other names: Ospolot;|
| Active Comparator: Sulthiame 200 mg<br>Sulthiame film-coated tablets 200 mg once daily 15 weeks | Drug: Sulthiame<br>* oral<br>* Other names: Ospolot;|
| Active Comparator: Sulthiame 300 mg<br>Sulthiame film-coated tablets 300 mg once daily 15 weeks | Drug: Sulthiame<br>* oral<br>* Other names: Ospolot;|
| Placebo Comparator: Placebo<br>Placebo film-coated tablets once daily 15 weeks | Drug: Sulthiame<br>* oral<br>* Other names: Ospolot;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative change in apnea-hypopnea index (AHI) from baseline to Week 15 (at least 12 weeks of treatment at target dose) measured by PSG | change in apnea-hypopnea index (AHI) | from baseline to week 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Two-sided 95% confidence intervals for the difference in patient incidence between each sulthiame treatment group and placebo. | from baseline to week 15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sulthiame, obstructive sleep apnea