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

• Status: Recruiting
• Trial end date: 2023-05-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Desitin Arzneimittel GmbH
• Treatments: Sulthiame

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.