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    Summary
    EudraCT Number:2005-000411-10
    Sponsor's Protocol Code Number:4478944789
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2006-06-06
    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 ConcernedGermany - BfArM
    A.2EudraCT number2005-000411-10
    A.3Full title of the trial
    Effects of Pregabalin on mechanical hyperalgesia - EPOM
    A.3.2Name or abbreviated title of the trial where available
    EPOM
    A.4.1Sponsor's protocol code number4478944789
    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 SponsorBG-Kliniken Bergmannsheil, Dept. of Pain Management
    B.1.3.4CountryGermany
    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 organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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 nameLyrica
    D.3.2Product code not applicable
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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
    patients with pain for at least 6 months and hyperalgesia with one of the following diagnoses: peripheral nerve lesion, plexus lesion, radicular lesion, spinal lesion, polyneuropathy, postzosteric neuralgia, complex regional pain syndrome (CRPS)

    ICD classification codes : M54.1 ; G54.0 – 9 ; G55.0 – 8 ; G56.0 – 9 ; G57.0 – 9 ; G58.0 ; G59.8 ; G62.0 – 9 ; G63.2 ; G62.3 ; G63.8 ; G53.0
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10036105
    E.1.2Term Polyneuropathy
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10036105
    E.1.2Term Polyneuropathy
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10036378
    E.1.2Term Postherpetic trigeminal neuralgia
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10064334
    E.1.2Term Complex regional pain syndrome Type I
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10064335
    E.1.2Term Complex regional pain syndrome Type II
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • evaluation of the number of responders and non-responders in respect of mechanical hyperalgesia (stimulus-response-function (SRF) on static punctual stimuli evoking pain determined via pinprick)
    E.2.2Secondary objectives of the trial
    • Differences between active drug and placebo group in respect of:
    – Mechanical hyperalgesia;
    – Ongoing pain (rated via numerical rating scale);

    • Differences in additional QST (qualitative sensory testing) variables of the examination protocol (CDT = cold detection threshold, HDT = heat detection threshold, TSL = thermal sensory limen, PHS = number of paradoxical heat sensations during the TSL Procedure, CPT = cold pain threshold, HPT = heat pain threshold, MDT = mechanical detection threshold, MPT = mechanical pain threshold, ALL = dynamic mechanical allodynia, WUR = windup ratio, VDT = vibration detection threshold, PPT = pressure pain threshold);

    • Neuropathic Pain Symptom Inventory [Bouhassira et al. Development and validation of the Neuropathic Pain Symptom Inventory. Pain 2004; 108(3): 248-257.].
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Recruitment
    • Age above 18 years;
    • Neuropathic pain of at least 4/10 for at least 6 months;
    • Mechanical hyperalgesia;
    • One of the following diagnoses: peripheral nerve lesion, plexus lesion, radicular lesion, spinal lesion, polyneuropathy, postzosteric neuralgia, complex regional pain syndrome (CRPS);
    • No nerve block or other interventional treatment for at least 4 weeks;
    • Constant medication for at least 4 weeks;
    • Signed informed consent;
    • WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study medication;
    • Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy is minimized.
    WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea >= 12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level > 35mIU/mL]. Even women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential.

    Enrolment open titration
    • All principal inclusion criteria at recruitment
    • Relevant mechanical hyperalgesia: SRF affected/control at least 2.0 with a minimal SRF of 0.8. Extended specification for polyneuropathy: SRF outside normal range on one foot (normal range: women und 40 years: SRF > 4,65, women above 40 years: SRF > 5,71; men under 40 years: SRF > 7,10, men above 40 years: SRF> 4,49) OR SRF within normal range, but SRF affected/control at least 2.0 with a minimal SRF of 0.8 with a control region located at the ipsilateral hand.

    Enrolment double-blind phase
    • At least 30% reduction in mechanical hyperalgesia (SRF) (=”clinically meaningful reduction”) in the open titration;
    • WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study medication;
    • Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study (see above recruitment).
    E.4Principal exclusion criteria
    - Anaphylaxis on the active component or any other component of Lyrica or the
    placebo (Lyrica®: pregabalin, lactose-monohydrate, corn starch, talcum;
    capsule shells: gelatine, titanium dioxide (E 171), natriumdodecylsulfat,
    high dispersive siliciumdioxide, purified water; ink: shellac, black
    iron(II,III)-oxide (E 172), propyleneglycol, kaliumhydroxide; additionally
    in placebo: microcrystalline cellulose, sucrose octaacetate, magnesium
    stearate)
    - Intake of gabapentin or pregabalin within the last 4 weeks prior to
    recruitment
    - Any surgery within the last two months or any scheduled surgery within the
    study period (20 weeks);
    - Concurrent unstable disease involving any system, e.g. advanced carcinoma,
    acute myocardial infarction, renal failure, or any other condition that in
    the opinion of the Investigator would deem the patient unsuitable for the
    study;
    - History of cerebral vascular or other cerebral disease;
    - Concurrent chronic or acute pain of other origin (osteoarthritis), which is
    not treated effectively
    - Concurrent severe mental deficit, e.g. psychiatric disorders as defined by
    DSM IV including schizophrenia, mood disorders, organic brain syndrome,
    psychotic/delusional disorders, serious psychosis;
    - Concurrent serious neurological disease, e.g. dementia, multiple sclerosis,
    or any other disease that would have impact on the ability of the patient to
    give their consent for the participation in the study or influences the pain
    perception;
    - Concurrent atrioventricular block second degree or higher
    - Concurrent renal failure (CLcr < 30 ml/min)
    - Concurrent hereditary galactose-intolerance
    - Concurrent lapp-lactase insufficiency
    - Concurrent glucose-galactose-malabsorption
    - Concurrent sub-optimal stabilized Diabetes Mellitus (Hb1Ac > 12%)
    - Clinical apparent overdosage of opioids or psychopharmaca
    - Recent history (6 months) or current evidence of alcohol or drug abuse;
    - Participation in any other investigational drug or therapy study within the
    previous 90 days;
    - Women who are pregnant or breastfeeding;
    - Women with a positive pregnancy test on enrollment or prior to study drug
    administration;
    - Women of childbearing potential who are unwilling or unable to use an
    acceptable method to avoid pregnancy for the entire study period and for up
    to 4 weeks after the study. Women practicing abstinence should use a
    reliable method of contraception (except birth control pills) if they choose
    to become sexually active during the study.
    E.5 End points
    E.5.1Primary end point(s)
    number of responder /non-responder in respect of mechanical hyperalgesia
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    enriched design
    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.8.3 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.8.5The 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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    last subject’s decision to discontinue the taking of Lyrica resp. placebo, which means to end the trial
    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 months11
    E.8.9.1In the Member State concerned days
    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) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-06-06. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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)
    According to the protocol, all subjects can take part in an add-on phase, where they can obtain Lyrica® for up to 8 weeks for free. Because of its marketing authorisation Lyrica® can be prescribed by every physician after the add-on phase.
    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 Decision2005-03-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusOngoing
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