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

Primary Purpose

Obstructive Sleep Apnea

Status
Active
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Sulthiame
Sponsored by
Desitin Arzneimittel GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring sulthiame, obstructive sleep apnea

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pneumocare SRL

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Sulthiame 100 mg

Sulthiame 200 mg

Sulthiame 300 mg

Placebo

Arm Description

Sulthiame film-coated tablets 100 mg once daily 15 weeks

Sulthiame film-coated tablets 200 mg once daily 15 weeks

Sulthiame film-coated tablets 300 mg once daily 15 weeks

Placebo film-coated tablets once daily 15 weeks

Outcomes

Primary Outcome Measures

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)

Secondary Outcome 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.
Two-sided 95% confidence intervals for the difference in patient incidence between each sulthiame treatment group and placebo.

Full Information

First Posted
January 20, 2022
Last Updated
September 6, 2023
Sponsor
Desitin Arzneimittel GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT05236842
Brief Title
Efficacy, Safety and Tolerability of Sulthiame in Patients With Obstructive Sleep Apnea (OSA)
Official Title
Efficacy, Safety and Tolerability of Three Doses of Sulthiame in Patients With Obstructive Sleep Apnea.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 23, 2021 (Actual)
Primary Completion Date
August 15, 2023 (Actual)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Desitin Arzneimittel GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
sulthiame, obstructive sleep apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
placebo
Allocation
Randomized
Enrollment
298 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sulthiame 100 mg
Arm Type
Active Comparator
Arm Description
Sulthiame film-coated tablets 100 mg once daily 15 weeks
Arm Title
Sulthiame 200 mg
Arm Type
Active Comparator
Arm Description
Sulthiame film-coated tablets 200 mg once daily 15 weeks
Arm Title
Sulthiame 300 mg
Arm Type
Active Comparator
Arm Description
Sulthiame film-coated tablets 300 mg once daily 15 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo film-coated tablets once daily 15 weeks
Intervention Type
Drug
Intervention Name(s)
Sulthiame
Other Intervention Name(s)
Ospolot
Intervention Description
oral
Primary Outcome Measure Information:
Title
Relative change in apnea-hypopnea index (AHI) from baseline to Week 15 (at least 12 weeks of treatment at target dose) measured by PSG
Description
change in apnea-hypopnea index (AHI)
Time Frame
from baseline to week 15
Secondary Outcome Measure Information:
Title
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.
Description
Two-sided 95% confidence intervals for the difference in patient incidence between each sulthiame treatment group and placebo.
Time Frame
from baseline to week 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Pneumocare SRL
City
Namur
ZIP/Postal Code
5101
Country
Belgium

12. IPD Sharing Statement

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

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