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CompletedNCT05236842Updated Nov 29, 2023

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

A Phase 2 interventional study of Sulthiame in Obstructive Sleep Apnea, sponsored by Desitin Arzneimittel GmbH. Completed at 1 site in Belgium. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-11-29.

Sponsored by Desitin Arzneimittel GmbH · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
298
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Obstructive Sleep Apnea

Keywords

  • sulthiame
  • obstructive sleep apnea
03

In context

Sleep Apnea, Obstructive

2,263 studies on the registry are indexed under Sleep Apnea, Obstructive; 465 are open to participants now.

This study's enrollment of 298 is above the median of 53 across 1,490 interventional studies indexed under Sleep Apnea, Obstructive.

Browse Sleep Apnea, Obstructive studies →

Lead sponsor

Desitin Arzneimittel GmbH is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
298 participants (actual)

Study arms

  • Active comparator
    Sulthiame 100 mg

    Sulthiame film-coated tablets 100 mg once daily 15 weeks

    Drug: Sulthiame

  • Active comparator
    Sulthiame 200 mg

    Sulthiame film-coated tablets 200 mg once daily 15 weeks

    Drug: Sulthiame

  • Active comparator
    Sulthiame 300 mg

    Sulthiame film-coated tablets 300 mg once daily 15 weeks

    Drug: Sulthiame

  • Placebo comparator
    Placebo

    Placebo film-coated tablets once daily 15 weeks

    Drug: Sulthiame

Interventions

06

What researchers measure

Primary outcomes

  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

    change in apnea-hypopnea index (AHI)

    Time frame: from baseline to week 15

Secondary outcomes

  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.

    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

07

Study locations

1 site
  • Pneumocare SRL
    Namur, 5101, Belgium
08

References and documents

Publications

  • 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 25;406(10514):1983-1992. doi: 10.1016/S0140-6736(25)01196-1. Epub 2025 Oct 9. PubMed 41077049 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2021 to primary completion in Aug 2023, 20 months.

Of 47 phase 2 interventional studies under Sleep Apnea, Obstructive, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 46. This study's 20 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 20, 2022
First posted
Feb 11, 2022
StartActual
Nov 23, 2021
Primary completionActual
Aug 15, 2023
CompletionActual
Aug 31, 2023
Last update
Nov 29, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05236842
Lead sponsor
Desitin Arzneimittel GmbH
Responsible party
Sponsor
First posted
Feb 11, 2022
Start date
Nov 23, 2021
Primary completion
Aug 15, 2023
Completion
Aug 31, 2023
Last update
Nov 29, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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