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    Summary
    EudraCT Number:2017-004767-13
    Sponsor's Protocol Code Number:STM-026/K
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-12-28
    Trial results View 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 ConcernedSweden - MPA
    A.2EudraCT number2017-004767-13
    A.3Full title of the trial
    A randomized, placebo-controlled, multiple dose, double blind, phase IIb, dose guiding trial to explore safety and tolerability of four weeks treatment with sulthiame in patients with moderate to severe obstructive sleep apnea
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A placebo-controlled, multiple dose, phase IIb, dose guiding trial to explore safety and tolerability of four weeks treatment with sulthiame in patients with moderate to severe obstructive sleep apnea
    A.4.1Sponsor's protocol code numberSTM-026/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 organisationUniversity of Gothenburg - Centre for sleep and waking disorders
    B.5.2Functional name of contact pointProfessor Jan Hedner
    B.5.3 Address:
    B.5.3.1Street AddressMedicinaregatan 8B
    B.5.3.2Town/ cityGöteborg
    B.5.3.3Post codeSE-413 46
    B.5.3.4CountrySweden
    B.5.4Telephone number+46 73 500 2077
    B.5.5Fax number+46 31 834761
    B.5.6E-mailjan.hedner@lungal.gu.se
    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 film-coated tablet
    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 INNSULTIAME
    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 film-coated tablet
    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 INNSULTIAME
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to severe obstructive sleep apnea
    E.1.1.1Medical condition in easily understood language
    Moderate to severe obstructive sleep apnea
    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 20.0
    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
    The primary objective of this study is to explore the safety and tolerability of 4 weeks of treatment with different doses of sulthiame (STM) in patients with obstructive sleep apnea (OSA).
    E.2.2Secondary objectives of the trial
    Secondary objectives of the study are to explore the efficacy of 4 weeks of treatment with STM:
    • on sleep apnea activity (change in AHI from baseline measured by polysomnography [PSG])
    • on other sleep related variables measured by PSG, including calculated and estimated measures of sleep apnea reduction
    • on patient-reported outcomes (PROs) including health related quality of life (HRQoL)
    • on investigator-reported patient outcomes (global impression)
    • on psychomotor vigilance test (PVT)
    • on biomarkers
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The patients have to meet all of the following criteria to be eligible to enter the study:
    1) Provision of informed consent after the scope and nature of the study have been explained prior to any study specific procedures
    2) Able to speak, read and understand the local language and possess the ability to respond to questions, follow instructions, complete questionnaires and comply with the study procedures
    3) Male or female gender and aged 18 to 75 years (both inclusive)
    Female patients
    A female participant is eligible to participate if she is not pregnant, see Appendix A, not breastfeeding, and if at least one of the following conditions applies:
    a) Not a woman of childbearing potential (WOCBP) as defined in Appendix A
    OR
    b) A WOCBP who agrees to follow the contraceptive guidance in Appendix A during the treatment period and for at least 4 weeks after the last dose of study drug
    Male patients
    A male patient who has not been vasectomized at least 6 months before screening and partners with a WOCBP must be willing to follow the contraceptive guidance in Appendix A during the treatment period and for at least 4 weeks after the last study drug administration.
    4) BMI ≥20 kg/m2 and ≤35 kg/m2
    5) An AHI of ≥15 (based on the mean value of 2 sleep studies performed at baseline both with an AHI of ≥10)
    6) ESS score ≥6
    7) Previous treatment with CPAP that was stopped because of non-acceptance and/or non-tolerability
    E.4Principal exclusion criteria
    Patients meeting any of the following criteria will not be permitted to enter the study:
    1) Any OSA treatment within the last 4 weeks prior to baseline
    2) Patients who fulfil criteria for central sleep apnea syndrome or a dominant Cheyne-Stokes respiration or other clinically significant dyssomnia including periodic limb movement disorder, or parasomnia
    3) Severe nocturnal hypoxia defined as more than 10 episodes with an oxygen desaturation exceeding 50% or signs of lacking resaturation to ≥90% between desaturations on previous recordings according to the Investigator’s judgment
    4) Patients with insufficiently treated hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg). If treated, patients must have been on the same dose of antihypertensive medication for at least 4 weeks prior to inclusion
    5) Clinically stable respiratory failure defined as daytime hypercapnia with arterial pCO2 ≥6.5 kPa according to medical history
    6) Type 1 diabetes or insulin treated type 2 diabetes or poorly controlled type 2 diabetes (HbA1c above 42 mmol/mol or 6%)
    7) Medical history of previously experienced metabolic or respiratory acidosis
    8) Patient with renal failure or a serum creatinine >130 μmol/L at screening
    9) Patients with a significant hepatic disease or an ASAT or ALAT >2 times the upper limit of normal at screening
    10) Patients actively participating in any active weight loss treatment program including any weight loss medication (prescription or over-the-counter) within 2 months prior to Screening
    11) Patients with a relevant history or a current episode of depression, bipolar disorder, or any other significant psychiatric disorder
    12) Patients with a history or current suicidal ideation, suicidal behaviour or suicide attempt
    13) Uncontrolled congestive heart failure
    14)Myocardial infarction or coronary vessel intervention within the previous 12 months period or unstable angina pectoris
    15) Previously diagnosed or treated clinically significant cardiac arrhythmia
    16) Patients previously treated by uvulopalatopharyngoplastic surgery (UPPP) or any other type of surgery for OSA.
    17) Acute porphyria or untreated hyperthyreosis
    18) Clinically significant deviation in any screening laboratory measurements or at physical examination as judged by the Investigator
    19) Allergy/hypersensitivity to the investigational medicinal product (IMP), to chemically related products (e.g. sulfonamides) or to placebo
    20) History of severe allergy/hypersensitivity or any ongoing allergy/hypersensitivity
    21) An occupation designated as high risk or safety sensitive including handling complex machinery or professional drivers where there may be an increased risk for work or traffic accidents.
    22) Patients currently involved in shift-work
    23) Female patients: currently pregnant or breast-feeding
    24) Participation in another clinical study during the last 30 days
    25) Planned surgery during the study period or major surgery within 6 months before first dose
    26) History of alcohol or drug abuse during the last year
    27) Patients with a clinically significant gastrointestinal, neurological or haematological disorder or any other significant condition that, in the opinion of the Investigator, could interfere with participation in the study.
    E.5 End points
    E.5.1Primary end point(s)
    • AEs including serious adverse events (SAEs) and adverse events of special interest (AESI) (i.e. clinically relevant change in blood pressure, ECG verified cardiac ischemia [referring to “stenocardia” specified as adverse reaction in the Summary of Product Characteristics (SmPC)], and tachycardia [resting heart rate >100/min])
    • Resting blood pressure (systolic, diastolic, and mean arterial pressure [MAP]), pulse, respiratory rate, and vascular stiffness
    • BW, BMI, and waist and hip circumference ratio
    • Laboratory parameters (clinical chemistry, haematology, and urinalysis)
    • Lipid panel, glycemic variables, and venous blood gas panel
    • ECG
    E.5.1.1Timepoint(s) of evaluation of this end point
    Please refer to flow chart in Clinical Study Protocol
    E.5.2Secondary end point(s)
    • PSG:
    - Change from baseline to Week 4 in AHI
    - Change from baseline to Week 4 in Oxygen Desaturation Index 4% (ODI, 4%)
    • Change from baseline in PROs and investigator-reported patient outcomes
    - ESS
    - Clinical Global Impression Scale rating Severity and Improvement (CGI-S and CGI-I)
    - Patient Global Impression Scale rating Severity and Improvement (PGI-S and PGI-I)
    - Functional Outcomes of Sleep Questionnaire (FOSQ)
    - 36-Item Short-Form Health Survey (SF-36)
    • Change from baseline in PVT
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to flow chart in 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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    dose escalation
    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 trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 76
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state96
    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)
    Standard of care
    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 Decision2018-02-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-12-19
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