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    The EU Clinical Trials Register currently displays   38927   clinical trials with a EudraCT protocol, of which   6396   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2017-001844-36
    Sponsor's Protocol Code Number:1
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-06-21
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2017-001844-36
    A.3Full title of the trial
    MethylphenIdate for fatigue in haematological cancer. A randomized, double-blind, placebo-controlled, CROssover trial - the MICRO trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Methylphenidate for patients with haematological cancer – the MICRO trial
    A.3.2Name or abbreviated title of the trial where available
    MICRO trial
    A.4.1Sponsor's protocol code number1
    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 SponsorOdense University Hospital
    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 supportOdense University Hospital
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOdense University Hospital
    B.5.2Functional name of contact pointHenrik Frederiksen
    B.5.3 Address:
    B.5.3.1Street AddressKløvervænget 10, 12 sal
    B.5.3.2Town/ cityOdense C
    B.5.3.3Post code5000
    B.5.4Telephone number+4521849307
    B.5.5Fax number+456311 0961
    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. name Methylphenidate Alternova
    D. of the Marketing Authorisation holderAlternova A/S, Lodshusvej 11, 4230 Skælskør
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameMethylphenidate
    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.3.9.1CAS number 113-45-1
    D.3.9.4EV Substance CodeSUB08870MIG
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 placeboTablet
    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
    Cancer related fatigue in patients with haematological cancer disease
    E.1.1.1Medical condition in easily understood language
    Fatigue in patients with cancer of the bone marrow or lymphomas
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10066564
    E.1.2Term Chronic fatigue
    E.1.2System Organ Class 100000023225
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To study if methylphenidate is superior compared to placebo in relieving fatigue and thereby improving
    • hours awake
    • time spend at work, being social, house work / gardening, being outside, participating in excercise
    • WHO performance status
    • muscle strength and endurance
    • quality-of-life
    • number of blood transfusions
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Malignant haematological disease such as
    o Myeloproliferative neoplasm
    o Myelodysplasia / Acute Myeloid Leukemia / Chronic Myelomonocytic leukemia
    o Acute lymphoblastic leukemia
    o Malignant lymphoma
    o Chronic lymphocytic leukemia
    o Multiple myeloma
    • Patient reported fatigue equals to a VAS score of 4 or more on a scale of 0 to 10 on (0 = no fatigue to 10 = worst possible fatigue). Score must be the patients retrospective estimate of usual fatigue during the past two weeks
    • Out-patient at inclusion
    • Hb ≥ 5 mmol/l on the past three hb measurements
    • Age ≥ 18 years
    • Ability to read and understand Danish language
    • Safe contraception for fertile women
    E.4Principal exclusion criteria
    • Chemotherapy within last 8 weeks. Patients on a stable dose previous 4 weeks of the following, may be included:
    o Kinase inhibitors (such as Imatinib, Dasatininb, Nilotinib, Ruxulitinib, Bosutinib and others)
    o Hydroxyurea
    o Chlorambucil
    o Busulfan
    o Melphalan
    o alfa-interferon
    o IMIDs (such Thalidomide, Lenalidomide, Pomalidomide and others)
    o monoclonal anti-bodies
    o 5-azacytidin
    o Combinations of above mentioned drugs and with corticosteroids (CS) are allowed as long as CS dose restrictions are followed.
    • Glucocorticoid treatment exceeding the equal of prednisolone 10mg / day or equivalent average dose / week and dosage must have remained stable during the past 4 weeks.
    • Current infection
    • Previous or current diagnosis made by a psychiatrist of psychosis, mania, or Tourette
    • Known previous suicidal attempts
    • Current psycho-pharmacological treatment
    • Known cardio-vascular disease. Patients with known stable angina pectoris may be included.
    • Prolonged QT interval corrected (QTc) >500msec at screening ECG
    • Known cerebro-vascular disease
    • Uncontrolled hypertension defined as SBP > 160 mmHg or DBP > 100mmHg
    • Cognitive impairment as judged by investigator
    • Change in opiod dose during the past two weeks
    • Life expectancy < 4 months
    • EPO started or dosage changed < 6 weeks prior to inclusion
    • Hypothyroidism with thyroid hormone supplementation treatment started or dosage changed < 6 weeks before inclusion
    • Known hyperthyroidism
    • Known pheochromocytoma
    • Known glaucoma
    • Previous or current substance abuse
    • Use of monoamine oxidase inhibitors within last two weeks
    • Known allergy to or side-effects from previous methylphenidate treatment
    • Pregnancy or breast feeding
    • Serious medical illness which in the judgement of the investigator would make the patient
    inappropriate for inclusion in the study
    E.5 End points
    E.5.1Primary end point(s)
    Primary end-point
    • Patient reported fatigue reduction after six weeks of MTP treatment measured by FACIT-F scale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of six weeks, end of 13th week and end of study 15th week
    E.5.2Secondary end point(s)
    Secondary end-points
    • Changes in hours awake
    • Changes in time spend at work, being social, house work / gardening, being outside, participating in excercise
    • Changes in WHO performance status
    • Changes in muscle strength and endurance
    • Changes in quality-of-life
    • Changes in number of blood transfusions
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of six weeks, end of 13th week and end of study 15th week
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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 concerned7
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months10
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 110
    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 state150
    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)
    Responders are offered to continue Methylphenidate after finishing protocol treatment
    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 Decision2017-09-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-21
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
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