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    Summary
    EudraCT Number:2015-000263-14
    Sponsor's Protocol Code Number:PS017-15
    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:2015-02-12
    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 number2015-000263-14
    A.3Full title of the trial
    Mycophenolate Treatment for Longstanding Complex Regional Pain Syndrome (MYPS I)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Mycophenolate Treatment for Longstanding Complex Regional Pain Syndrome (MYPS I)
    A.3.2Name or abbreviated title of the trial where available
    MYPS I
    A.4.1Sponsor's protocol code numberPS017-15
    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 SponsorWalton Centre NHS Foundation Trust
    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 supportPain Relief Foundation
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationWalton Centre NHS Foundation Trust
    B.5.2Functional name of contact pointDr Andreas Goebel
    B.5.3 Address:
    B.5.3.1Street AddressLower Lane
    B.5.3.2Town/ cityLiverpool
    B.5.3.3Post codeL9 7LJ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 (0) 151 529 5820
    B.5.6E-mailandreasgoebel@rocketmail.com
    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 Mycophenolate mofetil
    D.2.1.1.2Name of the Marketing Authorisation holderAccord Healthcare Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameMycophenolate mofetil
    D.3.2Product code LS017-15
    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 INNMycophenolate mofetil
    D.3.9.1CAS number 128794-94-5
    D.3.9.2Current sponsor codeL017-15
    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 number500
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Complex Regional Pain Syndrome (CRPS)
    E.1.1.1Medical condition in easily understood language
    A chronic regional disease characterised by pain, swelling and changes in the skin
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    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
    To provide first prospective proof of concept data on the activity (pain relief, and change in objective markers: quantitative sensory testing (QST), limb volume) of mycophenolate, an immune suppressant drug, in patients with longstanding, moderate to severe complex regional pain syndrome (CRPS).

    Also to provide first feasibility data on the tolerability of mycophenolate in a UK CRPS patient setting, including the typical time required for up-titration to maximal dose; also to provide feasibility data on the standard deviation of the pain outcome measure.
    E.2.2Secondary objectives of the trial
    To gain first data on the safety of mycophenolate treatment in patients with moderate to severe CRPS; explore time to pain-return-to-baseline; and explore treatment effect on function, quality of life, and healthcare costs.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of Complex Regional Pain Syndrome I or II according to Budapest research criteria (appendix 2)
    2. Disease duration of >2 years, and a mean pain intensity on an 11-point (0-10) Numeric Rating Scale (NRS) over the first fourteen daily entries after screening of 5 or higher (and no single daily pain intensity value below 5, a minimum of 13 valid scores need to be available).
    3. Failure to respond (poor efficacy or unacceptable side effects) to drugs recommended for the treatment of neuropathic pain, including pregabalin or gabapentin, a tricyclic antidepressant, and mild and strong opioids (where not contraindicated or refused by the patient).
    4. Previous pain-physiotherapy (where not contraindicated or refused)
    5. Willingness to confirm the use of adequate birth control while on the trial will be required in pre-menopausal women without evidence for an inability to become pregnant.
    6. Willingness to not start any other treatment for CRPS until the end of active treatment.
    7. Age 18 years and above.
    8. Blood antibodies against varicella zoster confirming immunity against varicella infection (expected present in 90% of the population), to mitigate the risk of new varicella injection under immunosuppression.
    E.4Principal exclusion criteria
    1. Other significant chronic pains, which in the view of the study doctor may make assessment of the pain arising from CRPS difficult.
    2. If the patient recently started a new therapy for CRPS, which in the view of the study doctor may change the patient’s pain level during the time of participation in the trial.
    3. Unstable medical conditions.
    4. Pregnant or breastfeeding patients.
    5. Receiving mycophenolate for other reasons, or previously tried mycophenolate.
    6. Concomitant systemic treatment with other immunosuppressant drugs.
    7. Ongoing drug or alcohol misuse.
    8. Psychiatric or mental health disorder, which could in the judgment of the study doctor interfere with successful study participation.
    9. Unwillingness or inability to complete daily diaries, or inability to understand the questionnaires being used.
    10. Cancer other than basal cell carcinoma within the last 5 years. However those patients who have received definite treatment, such as curative surgery more than 6 months ago, with no known recurrence can be included.
    11. Specific contraindications to mycophenolate.
    12. Renal failure or serum creatinine greater than 1.5 times the upper limit of normal at screening.
    13. Liver failure, any blood dyscresia.
    14. Any medical condition, which in the opinion of the investigator would make it unsafe for the patient to participate or which would interfere with assessment of the outcome measures.
    15. Participation in another interventional trial within 3 month before randomization. Participation in non-interventional studies is not a reason for exclusion.
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcome: the average pain relief at the primary endpoint (average 24h pain intensity on an 11-point NRS scale over a 14 day period starting 5 months after randomization (from day 150) versus baseline (baseline=14-day period following screening), compared between active and control groups.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Participants will fill in daily pain diaries for 14 days before randomisation (baseline data). This will be from day -21 onwards and the average pain score calculated.

    Participants in both active and control groups will fill in daily pain diaries from day 150 for 14 days. The average pain score will be calculated for comparison to baseline data. The change in pain intensity between the active and control groups will be compared.
    E.5.2Secondary end point(s)
    1: the average pain relief over the final 14 days of active treatment, compared with baseline in the active group (combined data from active group on active treatment, and control group on active treatment).

    2: the average change in QST parameters at the end of active treatment, compared with baseline.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Pain intensity data collected at baseline (-21 for 14 days) and between 150-164 days for active group and pain intensity data collected between 150-164 days and between 314-328 days.

    2. For the active group this is comparing the QST at randomisation (day 0) and day 164. For the control group this is comparing the QST at day 164 and day 328.
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Routine treatment as established before trial start
    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 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
    The end of study will be 5.5 months after the last participant’s final study visit. Participants will complete diaries weekly for 5.5 months after their final visit and then questionnaires after 5.5 months, these will be posted to the researchers and therefore will not require a visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days31
    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: 11
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 12
    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)
    Mycophenolate will not be available after the study has been completed and participants will continue with their standard of care treatments. If mycophenolate proves to be effective in this study then we will pursue further research to assess whether mycophenolate should be made available as routine treatment under the NHS.
    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 Decision2015-04-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-27
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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