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    Summary
    EudraCT Number:2021-002926-26
    Sponsor's Protocol Code Number:STM-042/K
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-09-15
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2021-002926-26
    A.3Full title of the trial
    Efficacy, Safety and Tolerability of 3 doses of Sulthiame in Patients with Obstructive Sleep Apnea. A Randomized, Double-Blind, Placebo Controlled, Dose-Ranging Study
    Efficacité, sécurité et tolérabilité de 3 doses de sultiame chez les patients souffrant d'apnée obstructive du sommeil. Étude de détermination de la dose, randomisée, en double insu, contrôlée par placebo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy, Safety and Tolerability of Sulthiame in Patients with Obstructive Sleep Apnea
    A.4.1Sponsor's protocol code numberSTM-042/K
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorDesitin Arzneimittel GmbH
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDesitin Arzneimittel GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDesitin Arzneimittel GmbH
    B.5.2Functional name of contact pointDr. Corinna Hansen
    B.5.3 Address:
    B.5.3.1Street AddressWeg beim Jäger 214
    B.5.3.2Town/ cityHamburg
    B.5.3.3Post code22335
    B.5.3.4CountryGermany
    B.5.4Telephone number+494059101-234
    B.5.6E-mailhansen@desitin.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Ospolot 50 mg
    D.2.1.1.2Name of the Marketing Authorisation holderDesitin Arzneimittel GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSulthiame
    D.3.9.1CAS number 61-56-3
    D.3.9.4EV Substance CodeSUB10762MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Ospolot 200 mg
    D.2.1.1.2Name of the Marketing Authorisation holderDesitin Arzneimittel GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSulthiame
    D.3.9.1CAS number 61-56-3
    D.3.9.4EV Substance CodeSUB10762MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Obstructive sleep apnea
    Apnée obstructive du sommeil
    E.1.1.1Medical condition in easily understood language
    Obstructive sleep apnea
    Apnée obstructive du sommeil.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10055577
    E.1.2Term Obstructive sleep apnea syndrome
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of three different doses of Sulthiame (STM) compared to placebo on sleep apnea activity in adult patients with moderate to severe obstructive sleep apnea after at least 12 weeks of treatment at target dose.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of three different doses of STM after at least 12 weeks of treatment at target dose in patients with moderate to severe obstructive sleep apnea (OSA) on:
    - apnea/hyponea events
    - hypoxic burden
    - sleep quality
    - daytime sleepiness
    - patient’s symptoms and well-being
    - comorbidity-related outcomes
    - safety and tolerability of STM
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Willing and able to provide written informed consent
    2. Male or female aged 18 to 75 years inclusive
    3. OSA diagnosis according to the international classification of sleep disorders (ICSD)-3 criteria with an AHI ≥15 documented by PSG or polygraphy (PG)
    4. Currently not treated with CPAP or MAD (see further details in the protocol)
    5. An AHI of ≥15 to ≤50 (mean from 2 PSG recordings [2 nights] at baseline), AHI of at least 10 on each night
    6. BMI ≥18.5 kg/m2 and ≤35 kg/m2
    7. Women of childbearing potential (WOCBP) or men whose sexual partners are WOCBP must be able and willing to use at least 1 highly effective method of contraception for at least 2 months prior to the first dose of study drug, throughout the entire study period, and for 30 days after the last dose of study drug
    8. Willing and able to comply with the study design schedule and other requirements
    E.4Principal exclusion criteria
    1. Any OSA treatment within the last 4 weeks prior to screening
    2. Fulfilling criteria for a dominant central sleep apnea syndrome or a dominant Cheyne Stokes respiration
    3. Other clinically significant sleep disorder including periodic limb movement disorder, restless leg syndrome, periodic limb movements arousal index (PLMAI) >15, insomnia, parasomnia or narcolepsy
    4. Hypoventilation or hypoxemia due to chronic obstructive pulmonary disease or other respiratory condition
    5. Clinically relevant craniofacial malformation
    6. Any upper airway surgery for OSA within the last 12 months prior to baseline
    7. 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 2 months prior to the first PSG night
    8. Elevated blood pressure or uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg). If treated, patients must have been on the same dose of antihypertensive medication for at least 4 weeks prior to screening
    9. Uncontrolled congestive heart failure
    10. Myocardial infarction or coronary vessel intervention within the previous 6 months period or unstable angina pectoris
    11. Previously diagnosed or treated clinically significant cardiac arrhythmia
    12. Episode of major depression, bipolar disorder, or any other significant psychiatric disorder within the last 12 months prior to screening
    13. Significant neurological or cognitive disorders as detailed in the protocol
    14. Renal or hepatic failure as defined in the protocol
    15. History of severe allergy/hypersensitivity or any ongoing allergy/hypersensitivity requiring continuous medical treatment
    16. Known allergy/hypersensitivity to STM and ingredients or to sulfonamides
    17. Nightshift-workers, professional drivers, patients handling complex machinery or with any other occupation where there may be an increased risk for work or traffic accidents
    18. Participation in another clinical study during the last 30 days prior to screening
    19. Planned surgery during the study period or major surgery within 6 months prior to first dose of study drug
    20. History of alcohol or drug abuse during the last year, substance use disorder, positive urine drug screen for drugs of abuse at screening
    21. Intake of any protocol-specified prohibited medication
    22. Clinically significant gastrointestinal, metabolic, urinary, or hematological disorder or any other significant condition that, in the opinion of the investigator, could interfere with participation in the study. Note, acute porphyria and untreated hyperthyroidism are excluded.
    23. Type 1 diabetes or insulin treated type 2 diabetes or poorly controlled type 2 diabetes
    24. Current or active infection
    25. Positive COVID-19 polymerase chain reaction (PCR) test result within 30 days prior to screening or at screening, history of hospitalization for COVID-19 within 30 days prior to screening, or history of use of oxygen due to COVID-19 within 30 days prior to screening. Note that previous COVID-19 infection alone is not exclusionary and vaccination against SARS-CoV-2 is allowed, but must be documented.
    26. Planned COVID-19 vaccination during the trial participation or within 2 weeks prior to screening. Booster vaccinations are allowed.
    27. History of actual suicidal behavior or suicidal ideation of type 2 to 5 within one year prior to screening, or current suicidal ideation of any type (i.e. 1 to 5) as assessed by the C-SSRS at screening
    28. Female patients who are currently pregnant or breastfeeding
    Please see the full list of exclusion criteria in the study protocol.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is the relative change in AHI from baseline to Week 15 (at least 12 weeks of treatment at target dose) measured by PSG.
    E.5.1.1Timepoint(s) of evaluation of this end point
    As specified in the endpoints.
    E.5.2Secondary end point(s)
    • AHI Responder
    • Change in Oxygen desaturation Index
    • Change in overnight Oxygen Saturation
    • Change in sleep stages
    • Change in sleep quality parameter
    • Patient/Clinical global Impression Scale
    • Change in Epworth Sleepiness Scale
    • Change in Sleep Apnea Quality of Life
    • Change in Pittsburg Sleep Quality Index
    • Change in blood pressure
    •Change in body weight

    For the Efficacy endpoints please refer to section 6.2.2.1. of Final Clinical Study Protocol .
    E.5.2.1Timepoint(s) of evaluation of this end point
    As specified in the endpoints, and in the study procedures (section 10 of the Final Clinical Study Protocol).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarkers
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    France
    Germany
    Spain
    Czechia
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 220
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 148
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 368
    F.4.2.2In the whole clinical trial 368
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-02-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-08-08
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