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    Summary
    EudraCT Number:2014-004122-18
    Sponsor's Protocol Code Number:2012GR12
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-10-28
    Trial results View 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 number2014-004122-18
    A.3Full title of the trial
    A Prospective Study to Evaluate the Effect of Allopurinol on Muscle Energetics in Older People with Impaired Physical Function.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Allopurinol in Functional Impairment (ALFIE) Trial
    ‘Improving muscle strength’
    A.3.2Name or abbreviated title of the trial where available
    Allopurinol in Functional Impairment (ALFIE) Trial
    A.4.1Sponsor's protocol code number2012GR12
    A.5.4Other Identifiers
    Name:Sponsor ReferenceNumber:2012GR12
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity of Dundee, Tayside Clinical Trials Unit
    B.1.3.4Country
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Dundee, Tayside Clinical Trials Unit
    B.5.2Functional name of contact pointDr Stephen McSwiggan
    B.5.3 Address:
    B.5.3.1Street AddressTASC, Level 3 Residencies, Ninewells Hospital
    B.5.3.2Town/ cityDundee
    B.5.3.3Post codeDD1 9SY
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01382383233
    B.5.6E-mails.j.mcswiggan@dundee.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.2.5The 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 nameALLOPURINOL
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Capsule, hard
    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 INNALLOPURINOL
    D.3.9.1CAS number 315-30-0
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number300 to 600
    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, hard
    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
    FUNCTIONAL IMPAIRMENT
    E.1.1.1Medical condition in easily understood language
    decreased exercise capacity
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10065629
    E.1.2Term Decreased exercise endurance
    E.1.2System Organ Class 100000004867
    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 will be to see if Allopurinol can improve tiredness in the legs after exercise. To measure this we will be assessing the rate of metabolism (how quickly or efficiently the leg muscle uses up energy) before, during and after exercising leg muscles and using an MRI machine to measure this.
    E.2.2Secondary objectives of the trial
    There are a number of secondary objectives all designed to assess the effects of allopurinol on functional impairment.
    Namely how far the participant can walk in 6 minutes and on a short battery of exercise tests before and after a 20 week course of allopurinol or placebo

    • To assess the effect of allopurinol on the health of blood vessels walls elasticity (healthy blood vessels are more elastic than unhealthy one which stiffen up) and blood markers which indicate the health of blood vessels, how well the participant uses energy and how well their muscle metabolises oxygen.

    The study will also assess the effect of allopurinol on Quality of Life as measured by a short questionnaire
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age 65 and over
    • 6-Minute Walk Distance less than 400m
    E.4Principal exclusion criteria
    -Documented history of peripheral arterial disease
    -Pre-existing diagnosis of severe heart failure (LVEF<35%)
    -Malignancy under active treatment (excluding basal cell carcinoma)
    -Severe COPD (Physician diagnosis)
    -Intolerance to allopurinol
    -On long term high dose steroids (eq. Prednisolone>10mg/day due to risk of steroid induced myopathy and osteoporosis)
    -Immobility that would render the patient incapable of doing the Short Physical Performance Battery Test (SPPB) or 6MWT
    -Patients who have participated in any other clinical drug trial within the previous 30 days will be excluded
    -Cognitive impairment precluding informed consent
    -Patients with active acute gout
    -Patients who have had allopurinol in the previous 30 days or those on long-term allopurinol
    -Patients with chronic kidney disease with an eGFR of 30ml/ or less
    -Patients who have contraindications to MRS scanning
    As the leg is the only part of the body in the scanner (unlike traditional MRI) we will not specifically exclude patients who have claustrophobia. Should they still not wish to take part, this is covered under the exclusion criteria: “Any other considered by a study physician to be inappropriate for inclusion”
    -Patients who are allergic or contraindicated to GTN should be excluded from undertaking FMD
    -Any other considered by a study physician to be inappropriate for inclusion
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is to determine if allopurinol improves the initial rate of Phosphocreatine (PCr) recovery (ViPCr) in patients with impaired functional ability as measured by MRI, compared to placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    20 weeks
    E.5.2Secondary end point(s)
    • Change in forearm blood flow: measured by Flow Mediated Dilatation (FMD)
    • 6-Minute Walk Test- a measure of walking physical performance
    o Short Physical Performance Battery (SPPB) test-a brief validated measure of functional performance (gait speed, balance, chair stands) that is outcome measure of choice for trials to improve physical function in older people, and has been proposed to the FDA as a surrogate licensing marker
    • Health-related quality of life, measured using the EuroQoL, EQ-5D questionnaire
    • Lean body mass, measured using bioimpedance (Tanita 101 BIA machine)
    o F2-Isoprostanes and 8-OHdG – circulating biomarkers of oxidative stress (lipid peroxidation and oxidative DNA damage respectively)
    o Muscle Biopsy markers: TBARS, 4HE conjugation, and carbonylation, ATP, PCr, creatine, free ADP,AMP concentration and lactate assays
    o Post-exercise muscle perfusion: measured by Arterial spin labelling (ASL) using MR Spectroscopy
    • Muscle ADP level: measured by Pi/PCr ratio via MR Spectroscopy
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoint for all above secondary outcome measures is 20 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 No
    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) 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 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 trial1
    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 Information not present in EudraCT
    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 years2
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days30
    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: 0
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 124
    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 state124
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 124
    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)
    None
    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 not applicable
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-12-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-07-06
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