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    Summary
    EudraCT Number:2011-002070-23
    Sponsor's Protocol Code Number:EEGrofl
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-06-01
    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 number2011-002070-23
    A.3Full title of the trial
    Effects of roflumilast on cognition in healthy adults: a behaviour-EEG study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of roflumilast on memory, attention and response inhibition tested using computer tasks and elctrical brain activity
    A.3.2Name or abbreviated title of the trial where available
    Roflumilast and cognition
    A.4.1Sponsor's protocol code numberEEGrofl
    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 SponsorMaastricht University Medical Center
    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 supportZonMW
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMUMC+
    B.5.2Functional name of contact pointM. van Duinen
    B.5.3 Address:
    B.5.3.1Street AddressPostbus 616
    B.5.3.2Town/ cityMaastricht
    B.5.3.3Post code6200 MD
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031433881030
    B.5.5Fax number003143388
    B.5.6E-mailmarlies.vanduinen@maastrichtuniversity.nl
    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 Daxas
    D.2.1.1.2Name of the Marketing Authorisation holderNycomed 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.3.1Product nameDaxas
    D.3.2Product code 162401-32-3
    D.3.4Pharmaceutical form 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 INNROFLUMILAST
    D.3.9.1CAS number 162401-32-3
    D.3.9.3Other descriptive nameDaxas
    D.3.9.4EV Substance CodeSUB10358MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1400
    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 Yes
    D.3.11.13.1Other medicinal product typeantiinflammatory
    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
    None; this proof-of-principle study will examine the cognition enhancing effects of roflumilast in healthy subjects
    E.1.1.1Medical condition in easily understood language
    Not applicable
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Psychological processes [F02]
    MedDRA Classification
    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 is to evaluate whether roflumilast improves declarative episodic memory. Memory function will be assessed using the verbal learning task (VLT), which assesses short- and long-term memory, using word lists. This task is particularly relevant since it assesses declarative episodic memory, a function primarily involving the hippocampus. Considering the evidence of high PDE-4 expression in this specific structure, we expect a larger effect size for cognitive functions related to this brain area.
    E.2.2Secondary objectives of the trial
    Our second objective is twofold. Other types of cognition will be measured using the Stroop task, continuous performance task (CPT) and the spatial memory task (SMT). The first two tasks measure response inhibition and focused attention, the latter task measures spatial memory. In addition, EEG recordings are included to gain insight in the electrophysiological correlates of cognition. A sensory gating paradigm is included which enables us to examine the effect of our treatment on specific ERP components related to basic auditory processing
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • 18 to 35 years of age
    • Healthy (i.e. absence of all exclusion criteria), normal static binocular acuity (corrected or uncorrected),
    • Body mass index between 18.5 and 30
    • Willingness to sign an informed consent.
    • Positive evaluation on the memory screening
    E.4Principal exclusion criteria
    Volunteers who suffer from, or have a history of cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal, haematological, or psychiatric illness, will be excluded. Those volunteers who have a first-degree relative with a psychiatric disorder or a history of depressive disorder with or without suicidal risk will be excluded as well. Other exclusion criteria are excessive drinking (>20 glasses of alcohol containing beverages a week), pregnancy or lactation, use of chronic medication other than oral contraceptives, use of recreational drugs from 2 weeks before until the end of the experiment, smoking, orthostatic hypotension, lactose intolerance, and any sensory or motor deficits which could reasonably be expected to affect test performance.
    E.5 End points
    E.5.1Primary end point(s)
    Main study parameters are the scores on the memory tasks. The verbal learning task the object relocation task, and the spatial memory task are selected for this purpose. Secondary, the continuous performance test and the stroop task will be included to assess attention and response inhibition.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Data will be analysed after all 20 subjects have been tested.
    E.5.2Secondary end point(s)
    Event-related potentials inferred from the EEG signal during those tasks will be analysed. In addition, auditory evoked potentials will give an indication of the role of roflumilast in information processing. Finally, the ratio (S2/S1) of the P50 will be included as a measure of sensory gating.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Data will be analysed after all 20 subjects have been tested.
    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 No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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 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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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
    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 months10
    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 months10
    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: 22
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2011-06-01. Yes
    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 state22
    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)
    Not applicable
    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 Decision2011-05-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-04-16
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