Efficacy, Safety and Tolerability of Sulthiame in Patients With Obstructive Sleep Apnea (OSA)
NCT ID: NCT05236842
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
298 participants
INTERVENTIONAL
2021-11-23
2023-08-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Sulthiame 100 mg
Sulthiame film-coated tablets 100 mg once daily 15 weeks
Sulthiame
oral
Sulthiame 200 mg
Sulthiame film-coated tablets 200 mg once daily 15 weeks
Sulthiame
oral
Sulthiame 300 mg
Sulthiame film-coated tablets 300 mg once daily 15 weeks
Sulthiame
oral
Placebo
Placebo film-coated tablets once daily 15 weeks
Sulthiame
oral
Interventions
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Sulthiame
oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Desitin Arzneimittel GmbH
INDUSTRY
Responsible Party
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Locations
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Pneumocare SRL
Namur, , Belgium
Countries
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References
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Randerath W, Grote L, Stenlof K, Fietze I, Chevts J, Buntinx E, Albares J, Kuhn K, Hansen C, Volp A, Hedner J; FLOW study investigators. Sultiame once per day in obstructive sleep apnoea (FLOW): a multicentre, randomised, double-blind, placebo-controlled, dose-finding, phase 2 trial. Lancet. 2025 Oct 9:S0140-6736(25)01196-1. doi: 10.1016/S0140-6736(25)01196-1. Online ahead of print.
Other Identifiers
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2021-002926-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
STM-042/K
Identifier Type: -
Identifier Source: org_study_id