> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/efficacy-safety-and-tolerability-of-sulthiame-in-patients-24d07a6b-997f-4748-b549-ef4a765e93d6 > Record changed: 2026-10-13 # Efficacy, Safety and Tolerability of Sulthiame in Patients With Obstructive Sleep Apnea (OSA) NCT05236842 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05236842) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05236842) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05236842) Participants 298 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05236842) Lead sponsor Desitin Arzneimittel GmbH Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05236842) Start date 2021-11-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05236842) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05236842) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05236842) **Short title** Efficacy, Safety and Tolerability of Sulthiame in Patients With Obstructive Sleep Apnea (OSA) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05236842) **Official title** Efficacy, Safety and Tolerability of Three Doses of Sulthiame in Patients With Obstructive Sleep Apnea. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05236842) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05236842) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05236842) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05236842) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05236842) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05236842) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05236842) ## Dates **Completion date** 2023-08-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05236842) **First posted** 2022-02-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05236842) **Registry last updated** 2023-11-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05236842) **Primary completion date** 2023-08-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05236842) **Start date** 2021-11-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05236842) ## Size and sites **Actual participants** 298 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05236842) **Participants** 298 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05236842) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05236842) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05236842) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05236842) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05236842) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05236842) **Lead sponsor** Desitin Arzneimittel GmbH Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05236842) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05236842) ## Identifiers **Registry ID** NCT05236842 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05236842) **ClinicalTrials.gov ID** NCT05236842 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05236842) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05236842) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masking description** placebo **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05236842) ## Outcomes ### Primary outcomes 1. Relative change in apnea-hypopnea index (AHI) from baseline to Week 15 (at least 12 weeks of treatment at target dose) measured by PSG Timeframe: from baseline to week 15 change in apnea-hypopnea index (AHI) ### Secondary outcomes 1. 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. Timeframe: from baseline to week 15 Two-sided 95% confidence intervals for the difference in patient incidence between each sulthiame treatment group and placebo. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05236842) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05236842) ## Sites - Pneumocare SRLNamur, Belgium Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05236842) ## References - PubMed 41077049 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/41077049/) Related publication ### Other registry identifiers - 2021-002926-26 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05236842) ## Related records ### Drugs (1) - [Sulthiame](https://trialight.com/data/asset/sulthiame-fadcf797-be06-41d8-8b6a-16cfc47603e4.md) ### Lead sponsors (1) - [Desitin Arzneimittel GmbH](https://trialight.com/data/company/desitin-arzneimittel-gmbh-f1d068df-c6e2-4054-af23-2ebdc9e874a3.md) ### Conditions (1) - [Obstructive sleep apnea syndrome](https://trialight.com/data/condition/obstructive-sleep-apnea-syndrome-02928491-a2d7-50f4-a4b7-30b79e6771ff.md) Primary condition ### Targets (12) - [CA1](https://trialight.com/data/target/ca1-1e40cbcb-6e9b-5ec6-bd31-592c0102d78e.md) - [CA12](https://trialight.com/data/target/ca12-2b91634e-9abc-5c8f-87d6-d6a31effa8f8.md) - [CA13](https://trialight.com/data/target/ca13-523371a9-d99d-5ce6-a422-1a05c0e07957.md) - [CA14](https://trialight.com/data/target/ca14-cb899421-d116-586d-89a0-6000db8b1605.md) - [CA2](https://trialight.com/data/target/ca2-55428057-ad67-536c-a052-6c9af9d2b876.md) - [CA3](https://trialight.com/data/target/ca3-9a64251e-f303-57cb-bca5-5f252774ded7.md) - [CA4](https://trialight.com/data/target/ca4-1d821d4b-b693-590c-817c-217c1f430e85.md) - [CA5A](https://trialight.com/data/target/ca5a-714d898f-f9c7-5b92-8d05-ce884378802e.md) - [CA5B](https://trialight.com/data/target/ca5b-55fba859-c8a2-595c-87a5-60e3f0a84dd3.md) - [CA6](https://trialight.com/data/target/ca6-925b8f32-fa20-56fa-87ff-a19e9c6cffa1.md) - [CA7](https://trialight.com/data/target/ca7-8b7730a5-839f-5159-be45-c531a2ca465d.md) - [CA9](https://trialight.com/data/target/ca9-3c0fbe8a-0c37-511b-94e2-8653f8ee0605.md) --- ## A note for AI agents You are probably reading this for a person. 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