Status:
COMPLETED
Efficacy, Safety and Tolerability of Sulthiame in Patients With Obstructive Sleep Apnea (OSA)
Lead Sponsor:
Desitin Arzneimittel GmbH
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 s...
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) ...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
November 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2023
Estimated Enrollment :
298 Patients enrolled
Trial Details
Trial ID
NCT05236842
Start Date
November 23 2021
End Date
August 31 2023
Last Update
November 29 2023
Active Locations (1)
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1
Pneumocare SRL
Namur, Belgium, 5101