Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2014-001631-36
    Sponsor's Protocol Code Number:CPL061-01
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-09-09
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2014-001631-36
    A.3Full title of the trial
    A Double-blind, Randomised, Placebo Controlled Study of the Efficacy of Glycopyrronium bromide 1mg /5ml in the Treatment of Non-drug Induced Hypersalivation with an Open Single-arm Extension to Investigate Longer Term Efficacy and Safety of Glycopyrronium bromide
    Dvojitě slepá, randomizovaná, placebem kontrolovaná studie účinnosti Glycopyrronium bromidu 1mg/5ml v léčbě hypersalivace nezpůsobené léčivy s navazujícím jednoramenným otevřeným podáváním Glycopyrronium bromidu za účelem zkoumání jeho dlouhodobější účinnosti a bezpečnosti
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Assess the Efficacy and Safety of the Glycopyrronium bromide in the Treatment of Non-drug Induced Hypersalivation
    Studie zjišťující účinnost a bezpečnost Glycopyrronium bromidu v léčbě hypersalivace nezpůsobené léčivy
    A.4.1Sponsor's protocol code numberCPL061-01
    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 SponsorColonis Pharma Limited
    B.1.3.4CountryUnited Kingdom
    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 supportColonis Pharma Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAccord Research, s.r.o.
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressEvropská 2690/17
    B.5.3.2Town/ cityPraha 6
    B.5.3.3Post code16000
    B.5.3.4CountryCzech Republic
    B.5.4Telephone number+420602335548
    B.5.5Fax number+420224174573
    B.5.6E-mailmarietta.tesarova@accordresearch.eu
    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.3.1Product nameGlycopyrronium bromide 1mg/5ml
    D.3.4Pharmaceutical form Oral solution
    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 INNGLYCOPYRRONIUM BROMIDE
    D.3.9.1CAS number 596-51-0
    D.3.9.4EV Substance CodeSUB07951MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    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 Yes
    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 placeboOral solution
    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
    Neurodevelopmental disability associated with hypersalivation
    vývojové poruchy nervové soustavy spojené s hypersalivací
    E.1.1.1Medical condition in easily understood language
    Neurodevelopmental disability associated with drooling
    vývojové poruchy nervové soustavy spojené s nadměrnou tvorbou slin
    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 17.1
    E.1.2Level PT
    E.1.2Classification code 10064062
    E.1.2Term Neurodevelopmental disorder
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10020746
    E.1.2Term Hypersalivation
    E.1.2System Organ Class 100000004856
    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 and safety of glycopyrronium bromide in non-drug induced
    hypersalivation associated with neurodevelopemental disability
    hodnocení účinnosti a bezpečnosti glycopyrronium bromidu v léčbě hypersalivace nezpůsobené léčivy spojené poruchami vývoje nervového systému
    E.2.2Secondary objectives of the trial
    not applicable
    nerelevantní
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Children (male and female) ≥ 3 and < 18 years of age
    2. Neurodevelopmental disability associated with hypersalivation; defined as drooling in the absence of treatment so that clothing became damp on most days (approximately five to seven days per week) by confirming the Modified Teacher's Drooling Scale score ≥ 5
    3. Weight ≥ 13 kg
    4. Female subjects of childbearing potential must have a negative pregnancy test at screening
    5. Female subjects of childbearing potential must be practicing one of the following methods of birth control and must agree to continue with the regimen throughout the study: hormonal methods such as oral, implantable, injectable, or transdermal contraceptives for a minimum of 90 days before IMP administration; total abstinence from sexual intercourse; intrauterine device (IUD); double-barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream). Male subjects must also agree to use acceptable methods of birth control with their female partners, and this may include use of a male condom plus
    spermicide.
    6. Informed consent signed by both parents or legally acceptable representative and children ≥ 7 years (if the child is able to understand and sign the document)
    7. Ability and willingness of children and their parents/caregivers to comply with study requirements, including the visit requirements, study procedures, concomitant medication restrictions and diary completion
    1. Děti (mužského a ženského pohlaví) ve věku ≥ 3 a < 18 let
    2. Vývojové poruchy nervového systému spojené s hypersalivací, definované jako množství slin, kdy bez léčení dochází k provlhnutí oblečení ve většině dnů ( přibližně 5 - 7 x týdně), potvrzené Modifikovaným skóre tvorby slin dle Teachera ≥ 5
    3. Hmotnost ≥ 13 kg
    4. Osoby ženského pohlaví v reprodukčním věku musí mít negativní těhotenský test během skríningu
    Osoby ženského pohlaví musí používat jednu z následujících metod antikoncepce a musí souhlasit s tímto režimem v průběhu celé studie: hormonální metody jako orální, implantabilní,injekční nebo transdermální antikoncepce minimálně 90 dní před podáním IMP; totální sexuální abstinence, nitroděložní tělísko (IUD), dvoubariérová metoda (kondomy, vaginální houba, vaginální diafragma nebo vaginální kroužek se spermicidném želé nebo krémem). Osoby mužského pohlaví musí rovněž souhlasit s přijatelnou metodou atikoncepce, jako je kondom se spermicidem
    6. Informovaný souhlas podepsaný oběma rodiči nebo zákonným zástupcem a dítětem ve věku ≥ 7 let (jestliže dítě dokáže porozumět dokumentu a podepsat se)
    7. Schopnost a ochota dětí a jedich rodičů/opatrovatelů dodržovat požadavky studie včetně návštěv, studijních procedur, omezení souběžné medikace a vyplňování deníků
    E.4Principal exclusion criteria
    1. Use of any medication known to cause hypersalivation
    2. Use of glycopyrronium bromide within 24 hours prior to baseline
    3. Cholinergic or anticholinergic medications within three plasma half-lives of the medication
    prior to baseline
    4. Intrasalivary gland botulinum toxin within 10 months prior to baseline
    5. Intraoral devices or prosthetics for treatment of drooling within 1 week
    6. Acupuncture for treatment of drooling within 3 months
    7. History of any significant cardiovascular, hepatic, or renal disease
    8. Acute illness at the time of either the pre-study medical evaluation or dosing
    9. Abnormal and clinically significant laboratory test results
    10. Allergy or hypersensitivity to glycopyrronium bromide or other related products
    11. History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption
    12. Medical conditions contraindicating anticholinergic therapy
    13. Any other clinically significant abnormality, that in the Investigator’s opinion would put the subject at increased risk of illness or injury, would interfere with study participation, or would interfere with the evaluation or quality of the data
    14. Previous enrollment or randomization in this study
    15. Participation in another clinical trial with investigational drugs within the last 1 month before screening
    16. Pregnant or breastfeeding subjects
    1. Užívání jakékoli medikace způsobující hypesalivaci
    2. Užití glycopyrronium bromidu v průběhu 24 hodin před zařazením do studie
    3. Cholinergní a anticholinergní přípravky s plasmatickým poločasem kratším než je trojnásobek plasmatického poločasu medikace
    4. Intraglandulární aplikace botulotoxinu do slinných žláz před měně než 10 měsíci
    5.Intraorální přístroje a prostetické pomůcky ke snížení tvorby slin v posledním týdnu
    6. Akupunktura za účelem terapie nadmětné tvorby slin v posledních 3 měsících
    7. Významné kardiovaskulární, jaterní nebo ledvinové onemocnění v anamneze
    8. Akutní onemocnění v období screeningu nebo po zařazení
    9. Abnormální a klinický signifikantní výsledky laboratorních testů
    10. Alergie nebo hypersenzitivita na glycopyrronium bromid nebo jiné příbuzné produkty
    11. Polykací obtíže nebo jiné gastrointestinální onemocnění v anamnéze, které by mohlo ovlivnit vstřebávání
    12. Kontraindikace anticholinergní terapie
    13. Jakékoli jiné klinicky signifikantní abnormity, které by mohly dle názoru zkoušejícího znamenat zvýšení rizika onemocnění nebo zranění, ovlivnily by účast ve studii nebo mohly ovlivnit kvalitu dat
    14. Předchozí zařazení nebo randomizace do této studie
    15. Účast v jiné klinické studii s hodnocenými léčivy v posledním měsíci před screeningem
    16. Těhotenství a kojení
    E.5 End points
    E.5.1Primary end point(s)
    Rate of patients showing response from baseline to week 8. Response is defined as a decrease in modified 9-point Teacher’s Drooling Scale (mTDS) by 3 units.
    Proporce pacientů , u kterých došlo k odpovědi od zařazení do 8. týdne. Odpověď je definována jako pokles hodnoty modifikovaného skóre tvorby slin dle Teachera o 3 jednotky
    E.5.1.1Timepoint(s) of evaluation of this end point
    8th week
    8 .týden
    E.5.2Secondary end point(s)
    1. Longer-term response to glycopyrronium bromide within 24 weeks of administration
    2. mTDS at individual time points
    3. Global assessment of treatment completed by parent/caregiver and investigator at week 8 and study end·
    4. VAS assessment of extent of drooling by parent/caregiver and investigator at each visit
    1. Dlouhodobější odpověď na glycopyrronium bromide při podávání po dobu 24 týdnů
    2. mTDS v jednotlivých časových úsecích
    3. celkové hodnocení léčby rodičem/opatrovatelem a zkoušejícím v 8. týdnu a při ukončení studie
    4: VAS hodnocení rozsahu tvorby slin rodičem/opatrovatelem a zkoušejícím během každé návštěvy
    E.5.2.1Timepoint(s) of evaluation of this end point
    Ad1) 24 th week
    Ad2) 3times/day during 3 days prior to baseline, then on one day weekly - 3 times/d.
    Ad 3) Week 8 and week 24 or at withdrawal
    Ad4) Baseline, week 2, 4, 6, 8, 10,12, 16, 20, 24 or at withdrawal
    Ad1) 24.týden
    Ad2) 3xdenně v průběhu 3 dnů před zařazením, poté jeden den týdně
    Ad3) Týden 8 a týden 24 nebo vyřazení
    Ad4) Zařazení, týden 2, 4, 6, 8, 10, 12, 16, 20, 24 nebo vyřazení
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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 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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    Georgia
    Slovakia
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months11
    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 Yes
    F.1.1Number of subjects for this age range: 100
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 40
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 60
    F.1.2Adults (18-64 years) No
    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 No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    children with neurodevelopmental disability
    děti s poruchou vývoje nervového systému
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 100
    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
    žádná
    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 Decision2015-02-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-15
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Wed May 28 21:16:57 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA