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    Summary
    EudraCT Number:2017-002127-16
    Sponsor's Protocol Code Number:UCAB-CT-03
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-07-05
    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 ConcernedFinland - Fimea
    A.2EudraCT number2017-002127-16
    A.3Full title of the trial
    A phase IIa study of GR3027 in patients with idiopathic hypersomnia (IH) involving an open-label part to assess safety, tolerability and pharmacokinetics (PK) of a single oral GR3027 dose in female patients and a randomized, double-blind, placebo-controlled crossover study to assess safety, tolerability, exposure and exploratory efficacy of multiple oral doses of GR3027 in male and female IH patients.
    GR3027-valmisteen käyttöä idiopaattisen liikaunisuuden hoidossa koskeva IIa vaiheen tutkimus, jonka avoimessa osiossa arvioidaan suun kautta otettavan GR3027-kertaannoksen turvallisuutta, siedettävyyttä ja farmakokinetiikkaa naisilla ja jonka satunnaistetussa, kaksoissokkoutetussa, lumekontrolloidussa, vaihtovuoroisessa tutkimusosiossa arvioidaan useasti suun kautta otettaviin GR3027-annoksiin liittyvää turvallisuutta, siedettävyyttä ja altistusta sekä tehokkuutta koskevia tietoja naisilla ja miehillä
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study in patients with idiopathic hypersomnia involving two parts. Part A is an an open-label study to assess safety, tolerability and pharmacokinetics of a single oral GR3027 dose in female patients. Part B is a randomized, double-blind, placebo-controlled crossover study to assess safety, tolerability, exposure and exploratory efficacy of multiple oral doses of GR3027 in male and female IH patients.
    GR3027-valmisteen käyttöä tutkitaan liikaunisuuden hoidossa, jonka avoimessa osiossa arvioidaan suun kautta otettavan GR3027-kertaannoksen turvallisuutta, siedettävyyttä ja farmakokinetiikkaa naisilla ja jonka kaksoissokkoutetussa, lumekontrolloidussa tutkimusosiossa arvioidaan useasti suun kautta otettaviin GR3027-annoksiin liittyvää turvallisuutta, siedettävyyttä ja altistusta sekä tehokkuutta koskevia tietoja naisilla ja miehillä
    A.4.1Sponsor's protocol code numberUCAB-CT-03
    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 SponsorUmecrine Cognition AB
    B.1.3.4CountrySweden
    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 supportUmecrine Cognition AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUmecrine Cognition AB
    B.5.2Functional name of contact pointChief Executive Officer
    B.5.3 Address:
    B.5.3.1Street AddressFogdevreten 2
    B.5.3.2Town/ citySolna
    B.5.3.3Post codeSE-17165
    B.5.3.4CountrySweden
    B.5.4Telephone number46852484484
    B.5.6E-mailmagnus.doverskog@umecrine.com
    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 No
    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.3.2Product code GR3027
    D.3.4Pharmaceutical form Capsule
    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 INNNot yet available
    D.3.9.1CAS number 2089238-18-4
    D.3.9.2Current sponsor codeGR3027
    D.3.9.3Other descriptive nameGR3027
    D.3.9.4EV Substance CodeSUB180296
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 No
    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.3.2Product code GR3027
    D.3.4Pharmaceutical form Capsule
    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 INNNot yet available
    D.3.9.1CAS number 2089238-18-4
    D.3.9.2Current sponsor codeGR3027
    D.3.9.3Other descriptive nameGR3027
    D.3.9.4EV Substance CodeSUB180296
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 placeboCapsule
    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
    Idiopathic hypersomnia (IH)
    E.1.1.1Medical condition in easily understood language
    Idiopathic hypersomnia (IH)
    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 HLT
    E.1.2Classification code 10028714
    E.1.2Term Narcolepsy and hypersomnia
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part A: The primary objective is to assess the safety and tolerability of GR3027 after a single oral dose of GR3027 in female patients with IH.

    Part B: The primary objective is to assess the safety and tolerability of GR3027 after multiple dose administration in patients with IH.
    E.2.2Secondary objectives of the trial
    Part A: The secondary objective is to determine the single oral dose PK characteristics of GR3027 in female patients with IH.

    Part B: The secondary objectives are to evaluate the exploratory efficacy of GR3027 after multiple dose administration in patients with IH and to assess the exposure of GR3027 at steady state in patients with IH.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Have signed and dated an informed consent prior to beginning protocol required procedures.
    2. In part A, females age 18 to 55 years. In part B, males or females age 18 to 55 years.
    3. Meets the International Classification of Sleep Disorders criteria 3rd edition (ICSD-3) for the diagnosis of IH. The diagnosis is either done during screening or if within the last twelve months (as long as medical records are available for verification).
    4. ESS of 11 or greater (as assessed at the screening visit)
    5. An apnea-hypopnea index (AHI) < 15 within the last 12 months.
    6. Patients on current treatment for their hypersomnolence disorder may be enrolled after discontinuing the medication and a washout phase (at least 5 x half-lives of medication but not less than 14 days). The following exception from the 14 days washout is allowed: 5 days washout for modafinil treatment prior to baseline.
    7. Fertile female patients, willing to use a hormonal or non-hormonal intrauterine device (IUD) or condom together with a medically accepted method of birth control (diaphragm, sponge, cervical cap) or sexual abstinence and agree to continue use of this method for the duration of the study and thereafter for one month after the last dosing of the IMP. Fertile female patients using hormonal IUD must have had the IUD for at least a month and should plan to keep it during the study.
    8. Fertile male patients must be willing to use condom and contraceptive methods with a failure rate of < 1% to prevent pregnancy1 and drug exposure of a fertile female partner and refrain from donating sperm from the date of dosing until one month after dosing of the IMP.
    9. Women who are surgically sterile or two years post-menopausal may be included without fulfilling the above criteria on birth control.
    10. Men who are surgically sterile may be included without they/their partner fulfilling the above criteria on birth control.
    E.4Principal exclusion criteria
    1. History of pathological EEG as judged by the Investigator.
    2. Pathological ECG at screening as judged by the Investigator.
    3. Inability to swallow the required number of study medication capsules or otherwise comply with study procedures.
    4. Any concurrent illness which at the discretion of the Investigator would compromise patient safety and/or compromise the objectives outlined in the protocol. These could include but are not limited to cardiovascular, endocrine, neoplastic, gastrointestinal, hematologic, hepatic, immunologic, metabolic, neurological (other than narcolepsy/hypersomnia), psychiatric (incl. but not limited to depression, anxiety), pulmonary, and/or renal disease.
    5. Women with significant menstrual cycle related hypersomnolence (including premenstrual dysphoric syndrome (PMDS)).
    6. History of severe allergy/hypersensitivity or on-going allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to GR3027.
    7. Current or recent (within one year) history of abuse of drugs of abuse including alcohol, anabolic steroids or as defined by the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders).
    8. Positive screen for drugs of abuse at screening or at baseline prior to administration of the study treatment.
    9. Female patients who are pregnant or nursing.
    10. Abnormal renal or hepatic function as reflected by a serum creatinine > 2.0 mg/dL (177 micromol/L) or abnormal liver biochemical tests (AST or ALT > 2 x upper limit of normal) or serum bilirubin (more than 1.5 times upper limit of normal).
    11. Evidence of active chronic viral infection including hepatitis B (serum hepatitis B surface antigen positive), hepatitis C (e.g. HCV RNA positive), and/or Human Immunodeficiency Virus (HIV positive).
    12. Have an occupation that requires variable shift work or routine night shift.
    13. Participation in any other clinical study that included drug treatment with the last administration within the past 30 days or five half-lives (whichever is longer) prior to administration of study treatment in this study. Patients consented and screened but not dosed in previous clinical studies are not excluded.
    14. Use of hypnotics, stimulants, tranquilizers, antihistamines (except for non-sedating antihistamines), benzodiazepines or clonidine at the within 14 days prior to enrolment or during the study. Patients taking anticonvulsants for epilepsy are not eligible to participate even if they are willing to washout anticonvulsants for the study.
    15. Concomitant drugs that are metabolised by either CYP3A4, CYP2C8 or CYP2C9 and where there is a risk for drug-drug interactions will be prohibited during the study, as judged by the Investigator.
    16. Use of over the counter (OTC) products, prescription medications or off label medications for hypersomnolence disorders must be discontinued at least 5 x half-lives of the medication but not less than 14 days prior to baseline. The following exception from the 14 days washout is allowed: 5 days washout for modafinil treatment prior to baseline.
    17. Regular or recent (i.e. within 14 days prior to enrolment) use of any prescribed or nonprescribed medications which, at the discretion of the Investigator, might compromise safe patient participation in the study and/or interpretation of the study results.
    18. Unsuitable for the study as judged by Investigator.
    E.5 End points
    E.5.1Primary end point(s)
    Part A:
    Safety will be assessed by occurrence and frequency of AEs, SAEs, laboratory parameters, vital signs, ECG and physical examination.

    Part B: Safety will be assessed by occurrence and frequency of AEs, SAEs, laboratory parameters, vital signs, ECG and physical examination.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part A: During 24h, 48h and day 8

    Part B: During the treatment days and treatment day 7 and day 14 and 14 days after cross over last dose
    E.5.2Secondary end point(s)
    Part A: The following PK parameters will be determined: Area under the plasma concentration curve (AUC) 0->∞, AUCt, maximum concentration (Cmax), time to maximum concentration (Tmax), lambdaz, terminal half-life (T1/2), apparent total body clearance following extra vascular administration (CL/F), apparent volume distribution/fraction of drug absorbed (Vz/F).

    Part B:
    Exposure measured as pre-dose values (Cmin) of GR3027 at steady state.

    The following efficacy end points will be used to address the efficacy objective:
    - Change in Epworth Sleepiness Scale (ESS) from baseline to week 2 of each treatment period while taking placebo versus GR3027.
    - Change in Maintenance of Wakefulness Test (MWT) from baseline to week 2 of each treatment period while taking placebo versus GR3027.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Part A: During 24h and 48h

    Part B:
    • PK results Cmin in week 2 of each treatment period
    • Efficacy end point change from baseline to week 2 of each treatment period
    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 No
    E.6.10Pharmacogenetic Yes
    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 Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Part A is an open, single dose study. Part B is randomised, double blind, cross over study.
    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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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 No
    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
    LSLV
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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: 20
    F.1.3Elderly (>=65 years) No
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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 care as per local country.
    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 Decision2017-08-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-10-19
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