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

Phase 2

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Drug: Sulthiame

• Registration Number: NCT05236842
• Lead Sponsor: Desitin Arzneimittel GmbH

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

Study Timeline

• Study Start: 2021-11-23
• Study First Submitted: 2022-01-20
• Study First Submitted QC: 2022-02-02
• Study First Posted: 2022-02-11
• Primary Completion: 2023-08-15
• Study Completion: 2023-08-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 298

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sulthiame 100 mg	Sulthiame	Sulthiame film-coated tablets 100 mg once daily 15 weeks
Sulthiame 300 mg	Sulthiame	Sulthiame film-coated tablets 300 mg once daily 15 weeks
Sulthiame 200 mg	Sulthiame	Sulthiame film-coated tablets 200 mg once daily 15 weeks
Placebo	Sulthiame	Placebo film-coated tablets once daily 15 weeks

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Pneumocare SRL; 🇧🇪 Namur, Belgium