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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05236842
• Other study ID #: STM-042/K
• Secondary ID: 2021-002926-26
• Status: Completed
• Phase: Phase 2
• Start date: November 23, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: November 2023
• Source: Desitin Arzneimittel GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 298
• Est. completion date: August 31, 2023
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• Sulthiame
oral

Locations

Country	Name	City	State
Belgium	Pneumocare SRL	Namur

Sponsors (1)

Lead Sponsor	Collaborator
Desitin Arzneimittel GmbH

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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