Efficacy, Safety and Tolerability of Sulthiame in Patients With Obstructive Sleep Apnea (OSA)
NCT05236842 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 298
Last updated 2023-11-29
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.
Conditions
Interventions
- DRUG
-
Sulthiame
oral
Sponsors & Collaborators
-
Desitin Arzneimittel GmbH
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-11-23
- Primary Completion
- 2023-08-15
- Completion
- 2023-08-31
Countries
- Belgium
Study Locations
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