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    Summary
    EudraCT Number:2020-003768-16
    Sponsor's Protocol Code Number:DR-2019-00310
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-02-27
    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 number2020-003768-16
    A.3Full title of the trial
    A proof of concept phase II study with the PDE4 inhibitor roflumilast in people suffering from long-term cognitive sequela after stroke
    Fase 2 studie met de PDE4 inhibitor roflumilast in mensen met cognitieve stoornissen 1 jaar na CVA.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Cognitive effects of roflumilast in people with cognitive impairment after CVA.
    Cognitieve effecten van roflumilast bij mensen met cognitieve stoornissen na een CVA.
    A.3.2Name or abbreviated title of the trial where available
    Roflumilast to treat cognitive sequelae after stroke
    Cognitive effecten van roflumilast bij CVA.
    A.4.1Sponsor's protocol code numberDR-2019-00310
    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 SponsorHersenstichting
    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 supportHersenstichting
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMaastricht University
    B.5.2Functional name of contact pointPrincipal Investigator
    B.5.3 Address:
    B.5.3.1Street AddressUniversiteitssingel 40
    B.5.3.2Town/ cityMaastricht
    B.5.3.3Post code6229 ER
    B.5.3.4CountryNetherlands
    B.5.6E-maili.winkens@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 (EU)
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 Capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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, soft
    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
    Cerebrovascular accident
    Cerebrovasculair accident
    E.1.1.1Medical condition in easily understood language
    stroke
    beroerte
    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 aim of this study is to show that roflumilast can improve verbal memory performance in people who suffered a stroke. We will use the Verbal Word Learning Test (VWLT) and measure the delayed recall performance (after about 30 min). This test has been found to be sensitive for the positive effects of roflumilast in our previous studies. The tests measures episodic memory that reflects memory for personal events.
    E.2.2Secondary objectives of the trial
    Measuring effects on other cognitive functions (reaction time, attention, executive functions), on aspects of every day memory, activities in daily living, and well-being.
    We will use the Rivermead Behavioural Memory Test (RBMT), Letter-Digit Substitution Test (LDST), Trail Making Test (TMT) and a reaction time test (simple reaction time, movement time), the Hospital Anxiety and Depression Scale (Depression subscale, HADS-D), the Everyday Memory Questionnaire-Revised (EMQ-R), and a test for daily participation (Utrechtse Schaal voor Evaluatie van Revalidatie-Participatie (USER-P)).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, a participant must meet all of the following criteria:

    - 40 to 70 years of age;
    - willingness to sign an IC;
    - Objective cognitive complaint: memory performance on the delayed recall in the 15 words VWLT of below the normative score (corrected for education, sex and age) (see Van der Elst, van Boxtel, van Breukelen, & Jolles, 2005).
    E.4Principal exclusion criteria
    A potential subject who meets any of the following criteria will be excluded from participating in this study: Normal Pressure Hydrocephalus (NPH), Morbus Huntington, Parkinson's disease, HIV/AIDS, Hepatitis B and C, recent Transient Ischemic Attack (TIA), COPD Type Gold 3 and 4, history of schizophrenia, bipolar disorder or psychotic symptoms not otherwise specified or previous treatment for these diseases (lifetime), current affective disorder (i.e. anxiety or major depression), cognitive problems due to alcohol abuse, brain tumor, epilepsy, encephalitis or lack of capacity to consent to participation. Other exclusion criteria are current treatment with (or illicit use of) cannabis, opiates, benzodiazepines, Methylenedioxymethamphetamine (MDMA) and cocaine. Roflumilast is contraindicated in patients with moderate to severe liver impairment, accordingly patients with moderate or major liver impairments will be excluded (e.g. Child-Pugh B and C). Use of medication showing strong inhibition of either CYP3A4 (e.g. clarithromycin, antihistamines) or CYP1A2 (e.g. fluvoxamine, ciprofloxacin and other fluoroquinolones) is also an exclusion criterion because of interference with roflumilast metabolism resulting in reduced therapeutic effectiveness of roflumilast. Individuals with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption will be excluded, as both the placebo and roflumilast contain lactose monohydrate. Additionally, during the period of the present study, participants are not allowed to participate in other drug trials.

    E.5 End points
    E.5.1Primary end point(s)
    Expected increase in verbal learning task (VWLT) recall in words in the delayed condition (15 words) at 3 months
    E.5.1.1Timepoint(s) of evaluation of this end point
    -Baseline
    -acute
    -at 1.5 months of chronic intake of roflumilast
    -at 3 months of chronic intake of roflumilast
    -3 months follow-up post 3 months of chronic intake of roflumilast
    E.5.2Secondary end point(s)
    decrease in reaction time (simple reaction time, movement time), decrease in completion time and number of errors on the LDST and TMT, improved score on the RBMT, lower score (less complaints) on EMQ-R and the HADS-D, and higher participation score (higher frequency and satisfaction, less experience of limitations) on USER-P
    E.5.2.1Timepoint(s) of evaluation of this end point
    -Baseline
    -acute
    -at 1.5 months of chronic intake of roflumilast
    -at 3 months of chronic intake of roflumilast
    -3 months follow-up post 3 months of chronic intake of roflumilast
    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 No
    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 Yes
    E.8.1.7.1Other trial design description
    between-subjects
    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
    LVLS.
    Premature termination is indicated only when a reoccurring serious
    adverse effect (SAE) has led to unblinding of individual randomised
    subject codes and is considered to be a suspected unsuspected serious
    adverse reaction (SUSAR). All subjects that received roflumilast will be
    informed as will the accredited METC and the Competent Authority as
    indicated by GCP and national guidelines. Available data will be
    analysed.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    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 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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 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 state100
    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)
    The first phase of the study will be conducted according to a double-blind, randomized placebo-controlled, between-subjects design.
    The treatment group will have a final test session 3 months after treatment has stopped to test whether treatment has long-lasting effects.
    The participants of the placebo group will be asked whether they are interested to participate in an open label study for 3 months (same treatment and testing procedure as roflumilast group in first phase).
    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 Decision2021-05-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-12-01
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