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    The EU Clinical Trials Register currently displays   42758   clinical trials with a EudraCT protocol, of which   7042   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2017-001950-33
    Sponsor's Protocol Code Number:15/0592
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2018-06-06
    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 ConcernedUK - MHRA
    A.2EudraCT number2017-001950-33
    A.3Full title of the trial
    Methylphenidate versus placebo for fatigue in advanced cancer (MePFAC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Methylphenidate versus placebo for fatigue in advanced cancer (MePFAC)
    A.3.2Name or abbreviated title of the trial where available
    MePFAC
    A.4.1Sponsor's protocol code number15/0592
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN79478762
    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 SponsorUCL
    B.1.3.4CountryUnited Kingdom
    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 supportNational Institute for Health Research
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMarie Curie Palliative Care Research Department, UCL
    B.5.2Functional name of contact pointElli Enayat
    B.5.3 Address:
    B.5.3.1Street Address6th Floor Maple House, Wing B
    B.5.3.2Town/ city149 Tottenham Court Road
    B.5.3.3Post codeW1T 7NF
    B.5.4Telephone number020 7679 9713
    B.5.6E-mailz.enayat@ucl.ac.uk
    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.2.1.1.2Name of the Marketing Authorisation holderTioPharma
    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.3.8INN - Proposed INNmethylphenidate hydrochloride
    D.3.9.1CAS number 113-45-1
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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
    E.1.1.1Medical condition in easily understood language
    Fatigue caused by cancer or its treatment
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10016256
    E.1.2Term Fatigue
    E.1.2System Organ Class 10018065 - General disorders and administration site conditions
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    What is the clinical effectiveness of methylphenidate versus placebo for cancer-related fatigue in patients receiving palliative care?
    E.2.2Secondary objectives of the trial
    1. What are the effects of methylphenidate (versus placebo) on quality of life; mood; and activities of daily living in patients receiving palliative care?

    2. What are the adverse effects of methylphenidate (versus placebo) in patients receiving palliative care?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Aged 18 years or over
    2. Participant is willing and able to give informed consent for participation
    3. Advanced incurable cancer of all tumour types
    4. Moderate or severe fatigue (>3/10 on a numerical rating scale)
    5. Able and willing to comply with all study requirements, including ability to participate in study for ten weeks
    6. Participant is receiving generalist or specialist palliative care
    7. Willing to allow his or her General Practitioner to be notified of participation in the study
    E.4Principal exclusion criteria
    1. Pregnancy
    2. Females of childbearing potential and males who have sexual partners with child-bearing potential must be willing to use an effective method of contraception (hormonal or barrier method of birth control; true abstinence) from the time consent is signed until 6 weeks after treatment discontinuation and inform the trial if pregnancy occurs. For the purpose of clarity, true abstinence is when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence, withdrawal, spermicides only or lactational amenorrhoea method for the duration of a trial, are not acceptable methods of contraception)
    3. Females of childbearing potential must have a negative pregnancy test seven days or fewer prior to first dose administration and must be willing to have a pregnancy test at every physical visit during the study
    4. Females must not be breastfeeding
    5. Known sensitivity to methylphenidate or to any of the excipients
    6. History of glaucoma
    7. Known phaechromocytoma
    8. Planned general anaesthesia in the next nine weeks
    9. During treatment with non-selective, irreversible monoamine oxidase (MAO) inhibitors, or within a minimum of 14 days of discontinuing those drugs
    10. Clinical Hyperthyroidism or thyrotoxicosis. Patients must have a thyroid function test (T4 and TSH) showing no evidence of hyperthyroidism in three months prior to first dose administration of study medication
    11. Known diagnosis or history of severe depression, anorexia nervosa/anorexic disorders, suicidal tendencies, psychotic symptoms, severe mood disorders, mania, schizophrenia, psychopathic/borderline personality disorder
    12. Known diagnosis or history of severe and episodic (Type 1) bipolar (affective) disorder (that is not well controlled)
    13. Known pre-existing cardiovascular disorders including severe hypertension (BP >160/100mmHg), uncontrolled heart failure uncontrolled angina, arterial occlusive disease, haemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction (within last one year), potentially life-threatening arrhythmias and channelopathies
    14. Pre-existing cerebrovascular disorders, cerebral aneurysm, vascular abnormalities including vasculitis or stroke (within last one year) or known high risk factors for cerebrovascular disorders
    15. Current or previous psycho-stimulant use in last month
    16. Severe anaemia (Haemoglobin < 80g/L)
    17. Platelets <50 × 103/μL
    18. White blood count less than 1.5 x 109/litre
    19. Any evidence of severe or uncontrolled infection that in the view of the investigator makes it undesirable for the patient to participate in the trial
    20. Estimated glomerular filtration rate [eGFR] <45 ml/minute per 1·73 m²
    21. ALT > 2 x ULN or bilirubin > 1.5 x ULN
    22. Participating in another research study involving any investigational agents within four weeks prior to registration
    23. Insufficient English language skills to understand study documentation and complete assessments
    24. Current treatment with clonidine, warfarin, monoamine oxidase inhibitors or modafinil
    25. History of previous or current substance or alcohol dependency within the last one year
    26. Unable to swallow tablets/capsules
    27. History of poorly controlled epilepsy, or seizures related to underlying brain tumour
    28. Any other significant disease or disorder which, in the opinion of the Investigator, may put the participant at risk or affect the participant’s ability to take part in the study
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcome is fatigue at 6 weeks measured by the fatigue sub-scale of Functional Assessment of Chronic Illness Therapy (FACIT-F).
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 weeks
    E.5.2Secondary end point(s)
    Secondary outcomes are other measures of quality of life (using European Organisation for Research and Treatment of Cancer core Quality of Life Palliative Care questionnaire [EORTC QLQ-C15-PAL] and the EuroQol EQ-5D 5 level [EQ-5D-5L]), adverse events, activities of daily living; appetite; satisfaction of patients and carers; survival and need for other medication.
    E.5.2.1Timepoint(s) of evaluation of this end point
    3, 6 and 10 weeks
    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) 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 Yes
    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 concerned10
    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
    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 months5
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days16
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 115
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 115
    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 state215
    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)
    At the face-to face or telephone assessment at the end of week 10 (±4 days) the study will end. At that point participants will be assessed by the local clinical service and a decision will be made about whether or not methylphenidate should be prescribed depending upon local clinical assessment and patient and physician preference.

    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation North Thames Clinical Research Network
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-01-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-19
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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