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    Summary
    EudraCT Number:2012-001149-42
    Sponsor's Protocol Code Number:C-EEG
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2012-05-16
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2012-001149-42
    A.3Full title of the trial
    Cyclopentolate induced EEG changes in children
    Cyclopentolaat geinduceerde EEG veranderingen bij kinderen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Cyclopentolate induced EEG changes in children
    Cyclopentolaat geinduceerde EEG veranderingen bij kinderen
    A.3.2Name or abbreviated title of the trial where available
    Cycloplegic EEG
    Cycloplegisch EEG
    A.4.1Sponsor's protocol code numberC-EEG
    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 SponsorMedical Centre Haaglanden
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMedical Centre Haaglanden
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical Centre Haaglanden
    B.5.2Functional name of contact pointH.M. (Ellen) van Minderhout
    B.5.3 Address:
    B.5.3.1Street AddressPostbox 432
    B.5.3.2Town/ cityThe Hague
    B.5.3.3Post code2501 CK
    B.5.3.4CountryNew Caledonia
    B.5.4Telephone number0031703302932
    B.5.5Fax number0031703303130
    B.5.6E-mailvan.minderhout@gmail.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 Yes
    D.2.1.1.1Trade name Cyclopentolate hydrochloride 1%; 10 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderChauvin-Bausch&Lomb, Benelux NV, Brussels, Belgium
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 namecyclopentolate hydrochloride 1%; 10 mg/ml
    D.3.2Product code RVG 09359
    D.3.4Pharmaceutical form Eye drops
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 5870-29-1
    D.3.9.3Other descriptive nameCYCLOPENTOLATE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB01529MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 placeboEye drops
    D.8.4Route of administration of the placeboOcular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Adverse events central nervus system after cycloplegics. EEG changes after cyclopentolate 1%
    Veranderingen centraal zenuw stelsel na cycloplegica. EEG veranderingen na cyclopentolaat 1%.
    E.1.1.1Medical condition in easily understood language
    Adverse events central nervus system after cycloplegics. EEG changes after cyclopentolate 1%
    Veranderingen centraal zenuw stelsel na cycloplegica. EEG veranderingen na cyclopentolaat 1%.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10013760
    E.1.2Term Drug-induced extrapyramidal side effects
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare EEG pattern after cyclopentolate 1% with EEG pattern after placebo eye-drops.

    Primary outcome
    Detect if changes in EEG pattern are present after administration of two drops of cyclopentolate1% compared with placebo.

    Secondary outcomes
    Detect which pattern changes.
    Detection of time of onset of EEG pattern change(s).
    Detection of the amount and depth of EEG pattern change.
    Detect factors (e.g. age, BMI etc.) that influences onset of- and/or changes in EEG pattern.
    Het vergelijken het EEG patroon na cyclopentolaat 1% met het EEG patroon na placebo oogdruppels.

    Primaire uitkomst maat:
    Detecteren van EEG veranderingen na toediening van twee druppels cyclopentolaat 1% vergeleken met (twee druppels) placebo.

    Secundaire uitkomst maten:
    Detecteren welk patroon veranderd.
    Detecteren van tijd van onstaat van EEG veranderingen.
    Detecteren van de hoeveelheid en ernst/diepte van de veranderingen.
    Detecteren van faktoren (zoals leeftijd, BMI etc) die het onstaan en de soort en mate van veranderingen beinvloeden.
    E.2.2Secondary objectives of the trial
    To compare EEG pattern after cyclopentolate 1% with EEG pattern after placebo eye-drops.

    Primary outcome
    Detect if changes in EEG pattern are present after administration of two drops of cyclopentolate1% compared with placebo.

    Secondary outcomes
    Detect which pattern changes.
    Detection of time of onset of EEG pattern change(s).
    Detection of the amount and depth of EEG pattern change.
    Detect factors (e.g. age, BMI etc.) that influences onset of- and/or changes in EEG pattern.
    Het vergelijken het EEG patroon na cycloplegica met het EEG patroon na placebo oogdruppels.

    Primaire uitkomst maat:
    Detecteren van EEG veranderingen na toediening van twee druppels cyclopentolaat 1% met (twee druppels) placebo.

    Secundaire uitkomst maten:
    Detecteren welk patroon veranderd.
    Detecteren van tijd van onstaat van EEG veranderingen.
    Detecteren van de hoeveelheid en ernst/diepte van de veranderingen.
    Detecteren van faktoren (zoals leeftijd, BMI etc) die het onstaan en de soort en mate van veranderingen beinvloeden.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Healthy 6 to 16 year old volunteers, requiring an objective refraction because of standard departmental protocol, not having syndromes or diseases or behaviour or attention syndromes (e.g. ADHD or ADD or autism spectral conditions etc.) and possessing a normal or low BMI.
    Gezonde 6 tot 16 jarige kinderen, gepland voor een objectieve refractie volgens standaard afdelings protocol, niet lijdend aan syndromen of ziektes of gedrags- of aandachts stoornissen (zoals ADHD, ADD, autistische spectrum stoornissen etc) en een normaal of laag BMI bezittend.
    E.4Principal exclusion criteria
    Not meeting the inclusion criteria:
    Physical illness
    Having syndomes or diseases or disorders in behaviour or attention (e.g. ADHD, ADD or autism like conditions etc)
    Aged< 6 and >17 year
    High BMI (overweight, obesitas)
    Niet voldoen aan de inclusie criteria
    Lichamelijke ziekte
    Lijden aan syndromen, ziektes of of gedrags- of aandachts stoornissen (zoals ADHD, ADD, autistische spectrum stoornissen etc)
    Hoge BMI (overgewicht, obesitas)
    Jonger dan 6 jaar of ouder dan 16 jaar zijn
    E.5 End points
    E.5.1Primary end point(s)
    This investigator initiated study is designed as a prospective, single-centre, cross sectional, quantitative, randomized single blind placebo-controlled trial.
    The study investigate the presence, nature and severity of central nervus system changes with EEG recording and investigate risk factors for onset of central nervus system changes after two drops of cyclopentolate 1%. The duration will be approximately 12 months.

    Randomized
    • Two drops of cyclopentolate hydrochloride 1%, with an interval of 5 minutes in both eyes
    or
    • Placebo:


    Primary outcome is to detect the presence of EEG pattern changes after administration of 2 drops of cyclopentolate 1%.

    Dit onderzoek betreft een prospectieve, single-centre, cross sectioneel, kwantitatieve, enkel-blinde, placebo gecontroleerde, gerandomiseerde trial met herhaalde metingen.
    De studie onderzoekt de aanwezigheid en de aard van centraal zenuwstelstel bijwerkingen met behulp van EEG onderzoek en tevens risico factoren voor het onstaan van deze bijwerkingen bij kinderen na 2 druppels cyclopentolaat 1%. De studie duur van zal ongeveer 1 jaar zijn; tot 24 proefpersonen de EEG onderzoeken compleet hebben afgerond.


    Interventie:

    Gerandomiseerd: Twee druppels cyclopentolaat hydrochloride 1%; interval 5 minuten of twee druppels placebo; interval 5 minuten.

    Primaire uitkomst maat is het detecteren van EEG veranderingen na toediening van 2 druppels cyclopentolaat 1%

    E.5.1.1Timepoint(s) of evaluation of this end point
    The duration of the study will be approximately 12 months; untill 24 subjects completed the whole EEG measurements.


    De studie duur zal ongeveer 1 jaar zijn; tot 24 proefpersonen de EEG onderzoeken compleet hebben afgerond.

    E.5.2Secondary end point(s)
    Secondary outcomes are the kind of EEG pattern changes, detection of time of onset of EEG pattern changes, detection of the amount and depth of EEG pattern changes and detect factors that influences onset of- and/or changes in EEG pattern.

    Secondary outcomes are the kind of EEG pattern changes, detection of time of onset of EEG pattern changes, detection of the amount and depth of EEG pattern changes and detect factors that influences onset of- and/or changes in EEG pattern.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The duration will be approximately 12 months untill 24 subjects completed the whole EEG measurements.


    De studie duur zal ongeveer 1 jaar zijn; tot 24 proefpersonen de EEG onderzoeken compleet hebben afgerond.


    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.1.4Double blind No
    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 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 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
    The endpoint of study is defined as the moment all the measurements and reviews of have been done, all these data are admitted in SPSS database and the database is closed.
    The endpoint of study is defined as the moment all the measurements and reviews of have been done, all these data are admitted in SPSS database and the database is closed.
    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 months1
    E.8.9.1In the Member State concerned 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: 24
    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: 12
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 12
    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 Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 24
    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)
    No modifications in treatment. Treatment according to standard departemental protocol.
    Geen verandering in behandeling. De behandeling zal worden gestart of continueerd volgens standaard afdelings protocol.
    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 Decision2012-05-16
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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    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.

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