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.

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Drug: Sulthiame

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 Type: Interventional
• Enrollment (Actual): 298
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Namur, Belgium, 5101
    • Pneumocare SRL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sulthiame 100 mg; Sulthiame film-coated tablets 100 mg once daily 15 weeks	Drug: Sulthiame; oral; Other Names: Ospolot
Active Comparator: Sulthiame 200 mg; Sulthiame film-coated tablets 200 mg once daily 15 weeks	Drug: Sulthiame; oral; Other Names: Ospolot
Active Comparator: Sulthiame 300 mg; Sulthiame film-coated tablets 300 mg once daily 15 weeks	Drug: Sulthiame; oral; Other Names: Ospolot
Placebo Comparator: Placebo; Placebo film-coated tablets once daily 15 weeks	Drug: Sulthiame; oral; Other Names: Ospolot

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative change in apnea-hypopnea index (AHI) from baseline to Week 15 (at least 12 weeks of treatment at target dose) measured by PSG	change in apnea-hypopnea index (AHI)	from baseline to week 15

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Desitin Arzneimittel GmbH
• Investigators: Principal Investigator: Winfried J. Randerath, Professor, Center for Sleep Medicine & Respiratory Care, University of Cologne, Germany

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2021
• Primary Completion (Actual): August 15, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: January 20, 2022
• First Submitted That Met QC Criteria: February 2, 2022
• First Posted (Actual): February 11, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: obstructive sleep apnea; sulthiame
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Anticonvulsants; Sulthiame
• Other Study ID Numbers: STM-042/K; 2021-002926-26 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No