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    Summary
    EudraCT Number:2017-004856-41
    Sponsor's Protocol Code Number:CCTU0178
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-01-23
    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 number2017-004856-41
    A.3Full title of the trial
    Regeneration in Cervical Degenerative Myelopathy - a multi-centre, double-blind, randomised, placebo controlled trial assessing the efficacy of Ibudilast as an adjuvant treatment to decompressive surgery for degenerative cervical myelopathy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomised Placebo-controlled Double Blind Clinical Trial in Degenerative Cervical Myelopathy: The RECEDE Myelopathy Trial
    A.3.2Name or abbreviated title of the trial where available
    RECEDE Myelopathy
    A.4.1Sponsor's protocol code numberCCTU0178
    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 SponsorCambridge University Hospitals NHS Foundation Trust and University of Cambridge
    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 supportNIHR
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCambridge University Hospitals NHS Foundation Trust and University of Cambridge
    B.5.2Functional name of contact pointCarrie Bayliss
    B.5.3 Address:
    B.5.3.1Street AddressCambridge Clinical Trials Unit, Coton House Level 6, Flat 63, Box 401, Hills Road
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post code CB2 0QQ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01223348158
    B.5.6E-mailcarrie.bayliss@addenbrookes.nhs.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 nameIbudilast
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Capsule
    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 INNIbudilast 10 mg: The Japanese Pharmacopoeia (JP)
    D.3.9.1CAS number 50847-11-5
    D.3.9.2Current sponsor codeIbudilast
    D.3.9.3Other descriptive nameKetas; Medicinova MN-166; Vichang; AV411; KC-404; Pinatos
    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 number60 to 100
    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
    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
    Degenerative Cervical Myelopathy
    E.1.1.1Medical condition in easily understood language
    ‘Wear and tear’ arthritis (degenerative) affects the part of the spine in the neck (cervical), causing structural changes that compress and damage the spinal cord (myelopathy)
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    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 aim of this trial is to estimate the difference in the modified Japanese Orthopaedic Association (mJOA) score and the Visual Analogue Scale (VAS) neck pain at 6 months after surgery between Degenerative Cervical Myelopathy (DCM) patients randomised to Ibudilast and those randomised to placebo. The mJOA is a fully validated outcome assessment for function in DCM. The VAS is the most popular tool for the measurement of pain in DCM. The hypothesis is that Ibudilast improves neurological recovery following surgical decompression of DCM.
    E.2.2Secondary objectives of the trial
    1) To compare the clinical efficacy of Ibudilast treatment at 3, 6 and 12 months after surgery, using a representative range of DCM outcome assessments

    The exploratory objectives include:
    1) To undertake a health economic evaluation of Ibudilast therapy
    2) To assess the bioavailability of Ibudilast in the CSF and blood.
    3) To assess the informal care burden of DCM
    4) To assess the potential of novel quantitative clinical assessments (Gait Laboratory)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1. Carer Quality of Life (QoL) (Optional):
    Objective: to assess the informal care burden of DCM
    Carers of trial subjects, as many as would like to be involved, will be asked to complete the CarerQOL self-assessment at baseline, preoperatively and 3, 6 and 12 months post-operatively.

    The questionnaire will also include their relation to the study participant. The questionnaire takes approximately 10 minutes to complete.


    2. Gait Lab (sub-study for Addenbrooke’s only):
    Objective: to assess the potential of gait laboratory as a novel quantitative clinical assessments
    Alongside their clinician-administered assessments, patients at Addenbrooke’s only will be invited to complete a formal, quantitative gait assessment. This involves walking across a pressure sensitive floor mat that will collect information about the steps, pressure, time elapsed, stride length and width. The assessment takes approximately 10 minutes and will be performed in the pre-operative visit and the 3 and 6 months post-operative visits. All Addenbrooke's trial participants will be invited to participate in this sub-study.
    E.3Principal inclusion criteria
    • Male or female, ages 18 to 80 years who have granted informed consent to participate
    • Patients suffering from Degenerative Cervical Myelopathy
    • Have a preoperative mJOA score ≥8 and ≤14
    • Scheduled for first surgical decompression as part of usual clinical practice
    E.4Principal exclusion criteria
    • Previous surgery for DCM
    • DCM symptoms due to cervical trauma (at the discretion of the investigator)
    • Hypersensitivity to Ibudilast or any of the formulation components
    • Evidence of acute hepatitis, clinically significant chronic hepatitis, or evidence of clinically significant impaired hepatic function through clinical and laboratory evaluation including ALP> 1.5x ULN; ALT or AST > 2x ULN; GGT > 3x ULN
    • Evidence of thrombocytopenia at screening through laboratory evaluation including platelet count <5000
    • Active malignancy defined as history of invasive malignancy, except if the patient has received treatment and displayed no clinical signs and symptoms for at least five years
    • Recent history (less than 3 years) of chemical substance dependency or significant psychosocial disturbance that may impact the outcome or trial participation
    • Female patients with child bearing potential who are unwilling or unable to use reliable methods of contraception
    • Female patients who are pregnant, lactating or planning pregnancy during the course of the trial.
    • Inability to comply with trial procedures or follow-up schedule including IMP regime
    • Unable to take gelatin based product
    • Participation in another CTIMP or device within the past 30 days from the time of recruitment
    • Functional disability from a concomitant neurological disease that would mask the symptoms of DCM (at the discretion of the investigator). Including but not limited to stroke with residual disability, cerebellar ataxia, Parkinson’s disease, symptomatic lumbar stenosis and multiple sclerosis.
    • Resting pulse < 50 bpm, SA or AV block, uncontrolled hypertension, or QTcF > 450 ms
    • History of stomach or intestinal surgery or any other condition that could interfere with or is judged by the investigator to interfere with absorption, distribution, metabolism, or excretion of IMP
    • Unable to converse, read or write English
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measures are the change in the modified Japanese Orthopaedic Association Score (mJOA) and the change in Visual Analogue Scale (VAS) neck pain between screening and 6 months post-operatively. The mJOA is an 18-point clinician administered scale (0 worst to 18 best), which evaluates motor dysfunction in upper and lower extremities, loss of sensation, and sphincter dysfunction. The VAS Neck pain is a 10cm horizontal line, on which a patient indicates their level of neck pain from 0 (no pain) to 10 (worst pain).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary outcome will be evaluated as the difference in these parameters between baseline (screening visit) and 6-months post-operatively (±21 days). These two parameters are also evaluated for exploratory purposes in the pre-operative, 3 months and 12 months follow-up visits. VAS neck pain is also evaluated for exploratory purposes at post-operative visit.
    E.5.2Secondary end point(s)
    1. Physical Summary Score (PSC) of the Short Form 36 (SF-36) questionnaire: a well-recognised measure of patient physical health
    2. Mental Summary Score (MSC) of the Short Form 36 (SF-36) questionnaire: a well-recognised measure of patient mental health
    E.5.2.1Timepoint(s) of evaluation of this end point
    SF36 is evaluated at screening, pre-operative and then 3, 6 and 12 months post-operatively
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 concerned6
    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
    The end of trial is the date of the last assessment for the last patient (i.e. 12 month assessment post-surgery for last patient recruited).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days1
    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) Yes
    F.1.2.1Number of subjects for this age range: 217
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 145
    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 state362
    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)
    Patients will return to their normal clinical management for their disease. There will be no continued provision of study drug
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-03-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-06
    P. End of Trial
    P.End of Trial StatusOngoing
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