NCT05236842

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 sleep apnea activity in adult patients with obstructive sleep apnea.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
298

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 23, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 11, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2023

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

1.7 years

First QC Date

January 20, 2022

Last Update Submit

November 28, 2023

Conditions

Obstructive Sleep Apnea

Keywords

sulthiameobstructive sleep apnea

Outcome Measures

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)

    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.

    from baseline to week 15

Study Arms (4)

Sulthiame 100 mg

ACTIVE COMPARATOR

Sulthiame film-coated tablets 100 mg once daily 15 weeks

Drug: Sulthiame

Sulthiame 200 mg

ACTIVE COMPARATOR

Sulthiame film-coated tablets 200 mg once daily 15 weeks

Drug: Sulthiame

Sulthiame 300 mg

ACTIVE COMPARATOR

Sulthiame film-coated tablets 300 mg once daily 15 weeks

Drug: Sulthiame

Placebo

PLACEBO COMPARATOR

Placebo film-coated tablets once daily 15 weeks

Drug: Sulthiame

Interventions

SulthiameDRUG

oral

Also known as: Ospolot
PlaceboSulthiame 100 mgSulthiame 200 mgSulthiame 300 mg

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pneumocare SRL

Namur, 5101, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 41077049DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

sulthiame

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
placebo
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2022

First Posted

February 11, 2022

Study Start

November 23, 2021

Primary Completion

August 15, 2023

Study Completion

August 31, 2023

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations

BE(1)