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

NCT05236842
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Phase
Phase 2
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Recruitment status
Completed
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Participants
298
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Lead sponsor
Desitin Arzneimittel GmbH
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Start date
2021-11-23
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Number of sites
1
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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.
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Short title
Efficacy, Safety and Tolerability of Sulthiame in Patients With Obstructive Sleep Apnea (OSA)
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Official title
Efficacy, Safety and Tolerability of Three Doses of Sulthiame in Patients With Obstructive Sleep Apnea.
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 2
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Study type
Interventional
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Completion date
2023-08-31
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First posted
2022-02-11
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Registry last updated
2023-11-29
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Primary completion date
2023-08-15
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Start date
2021-11-23
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Actual participants
298
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Participants
298
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Participant count basis
Actual
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Protocol amendments
2
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Number of sites
1
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Desitin Arzneimittel GmbH
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05236842
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ClinicalTrials.gov ID
NCT05236842
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masking description
placebo
Masked roles
Participants, Investigators
Sources for study design
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  1. Relative change in apnea-hypopnea index (AHI) from baseline to Week 15 (at least 12 weeks of treatment at target dose) measured by PSG

    Timeframe: from baseline to week 15

    change in apnea-hypopnea index (AHI)

  1. 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.

    Timeframe: from baseline to week 15

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

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No

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.

Sources for eligibility
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  • Pneumocare SRLNamur, Belgium
Sources for sites
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Other registry identifiers

  • 2021-002926-26
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (12)