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

Overview

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.

Full Title of Study: “Efficacy, Safety and Tolerability of Three Doses of Sulthiame in Patients With Obstructive Sleep Apnea.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: March 30, 2023

Interventions

  • Drug: Sulthiame
    • oral intake of tablets

Arms, Groups and Cohorts

  • Active Comparator: Sulthiame 100 mg
    • Sulthiame film-coated tablets 100 mg once daily 15 weeks
  • Active Comparator: Sulthiame 200 mg
    • Sulthiame film-coated tablets 200 mg once daily 15 weeks
  • Active Comparator: Sulthiame 300 mg
    • Sulthiame film-coated tablets 300 mg once daily 15 weeks
  • Placebo Comparator: Placebo
    • Placebo film-coated tablets once daily 15 weeks

Clinical Trial Outcome Measures

Primary Measures

  • to evaluate the efficacy of three different doses of sulthiame compared to placebo on sleep apnea activity in adult patients with moderate to severe obstructive sleep apnea after 12 weeks of treatment at target dose.
    • Time Frame: from baseline to week 15
    • change in apnea-hypopnea index (AHI)

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Desitin Arzneimittel GmbH
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Corinna Hansen, PhD, +49 40 59101, hansen@desitin.de

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