NCT05236842

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 298 (actual)
• Sponsor: Desitin Arzneimittel GmbH · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DRUG	Sulthiame	oral

Timeline

• Start date: 2021-11-23
• Primary completion: 2023-08-15
• Completion: 2023-08-31
• First posted: 2022-02-11
• Last updated: 2023-11-29

Locations

1 site across 1 country: Belgium