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

Desitin

Status and phase: Completed; Phase 2

Conditions: Obstructive Sleep Apnea

Treatments: Drug: Sulthiame

Study type: Interventional

Funder types: Industry

Identifiers

NCT05236842

2021-002926-26 (EudraCT Number)

STM-042/K

Details and patient eligibility

About

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 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

Enrollment: 298 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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298 participants in 4 patient groups, including a placebo group

Sulthiame 100 mg

Active Comparator group

Description:

Sulthiame film-coated tablets 100 mg once daily 15 weeks

Treatment:

Drug: Sulthiame

Sulthiame 200 mg

Active Comparator group

Description:

Sulthiame film-coated tablets 200 mg once daily 15 weeks

Treatment:

Drug: Sulthiame

Sulthiame 300 mg

Active Comparator group

Description:

Sulthiame film-coated tablets 300 mg once daily 15 weeks

Treatment:

Drug: Sulthiame

Placebo

Placebo Comparator group

Description:

Placebo film-coated tablets once daily 15 weeks

Treatment:

Drug: Sulthiame