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    Summary
    EudraCT Number:2007-003230-42
    Sponsor's Protocol Code Number:F13640GE210
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-07-23
    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 ConcernedFrance - ANSM
    A.2EudraCT number2007-003230-42
    A.3Full title of the trial
    Study of the analgesic effects of repeated doses of F13640 in spinal cord injury patients with moderate to severe central neuropathic pain. A multinational, multicenter, randomized, double blind, parallel groups, placebo-controlled study.
    A.4.1Sponsor's protocol code numberF13640GE210
    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 SponsorPIERRE FABRE MEDICAMENT
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 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.3.2Product code F13640
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 208110-64-9
    D.3.9.2Current sponsor codeF13640
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 No
    D.3.11.8Extractive medicinal product No
    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
    Central neuropathic pain due to spinal cord injury, based on clinical history, clinical examination and appropriate assessment of patient’s signs and symptoms, according to the International Association for the Study of Pain (IASP) definition
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10064012
    E.1.2Term Central pain syndrome
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of F13640 in spinal cord injury patients with moderate to severe central neuropathic pain, when administered for 12 weeks including a 7-day titration period.
    E.2.2Secondary objectives of the trial
    To evaluate pain relief, impact on sleep, mood and motricity, safety and tolerability of F13640 in spinal cord injury patients with moderate to severe central neuropathic pain, when administered for 12 weeks including a 7-day titration period.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Out patient or institutionalised patient, male or female- Aged > or = 18 years and < or = 65 years
    - Diagnosis of spinal cord injury (post-traumatic, post-ischemic, non progressive myelitis, syringomylia…) for at least 1 year with stable neurological lesions for at least 6 months before the selection
    - Diagnosis of central neuropathic pain due to spinal cord injury, based on clinical history, clinical examination and appropriate assessment of patient’s signs and symptoms, according to the International Association for the Study of Pain (IASP) definition
    - Pain having persisted continuously for at least 6 months before the selection
    - 24-hour recall pain intensity score ≥ 4 and < or = 9 on a 11-point paper numerical rating scale at selection visit
    - Record of at least 4 assessable evaluations of the 24-hour recall pain intensity score in the PDA over the 7 days preceding the randomization
    - Average 24-hour recall pain intensity score of the last 7 days ≥ 4 on a 11-point numerical rating scale (NRS on PDA) before randomization visit- DN4 score ≥ 4 at selection
    - AST/SGOT and ALT/SGPT less than 2 times the upper normal values at the selection
    - Creatinine clearance > 60 ml/mn
    - QTc less than the upper limit of the normal range at the selection
    - For the other laboratory safety tests and ECG parameters, normal or considered as not clinically significant, in the investigator’s opinion
    - Patient having given his/her written informed consent or his/her oral informed consent attested by a witness independent of the investigator and the sponsor, in case of motor function impairement in the arms
    - Patients affiliated to a social security system, or is a workers beneficiary (if applicable in the national regulation)
    - Patient able to read and understand the text on the PDA screen, able to hear the audible prompts, and able to use a PDA device daily for the whole duration of the study. If the patient is physically unable to use the PDA or to complete self-reporting questionnaires or scales, he/she should be assisted by identified caregivers.
    E.4Principal exclusion criteria
    - All conditions that can interfere with the pain assessment: presence of pain of other origin (nociceptive, inflammatory or peripheral neuropathic pain component) that could confound the assessment of central neuropathic pain related to SCI (for example if the intensity of pain of other origin is higher than the intensity of the neuropathic pain or if the patients are unable to distinguish between neuropathic pain and pain of other origin)
    - Demyelinating disease (multiple sclerosis…)
    - Complex Regional Pain Syndrome and other above level neuropathic pain
    - Pain related to complete cauda equina lesions
    - Refractory neuropathic pain (no response to more than 3 therapeutic classes well conducted, previously taken for central neuropathic pain)
    - Significant cognitive impairment on the investigator’s opinion
    - Severe dysautonomic tension instability
    - Uncontrolled arterial hypertension (SBP >140 mm Hg and/or DBP > 90 mm Hg)
    - Major depression requiring a pharmacological treatment
    - Diabetes mellitus
    - Any clinically significant hepatic, renal, respiratory, gastro-intestinal, cardiovascular, autoimmune, hematological, neurological or psychiatric history or current disease unrelated to the cause of neuropathic pain which may interfere with pain evaluation and the course of the study on the investigator’s opinion
    - History of alcohol or narcotic abuse within the 6 months preceding the selection or alcohol or narcotic dependence within the 2 years preceding the selection
    - Pregnancy or breast-feeding
    - Woman of childbearing potential who is unwilling or unable to use a medically accepted and well documented method of contraception (chirurgical or hormonal birth control or intrauterine device only) during 2 months before the inclusion in the study, during the whole duration of the study and up to 1 month after the last dose of the study treatment, in order to avoid pregnancy while being exposed to the study treatment
    A pregnancy test will be carried out at the selection visit, on D1 before initiation of the treatment, after the last administration of study treatment on D84 (or PW) and at the end of study visit
    Man able to father a child unwilling or unable to practice an effective mean of birth control while participating in this study and up to one month after the last dose of the study treatment
    - Intake of any unauthorized treatment which cannot be stopped
    - For patients having been treated by a prohibited treatment, a wash-out period of at least 5 T1/2 of the treatment must be respected prior to inclusion on D1- Patient with previous history of pharmacological sensitivity or hypersensitivity to 5-HT agonists
    - History of drug allergy or current allergic reaction
    - Patient in the exclusion period of a previous study (at least 5 T1/2 of the previous investigational product)
    - Patient involved in any other biomedical research during the study
    - Patient who could not be contacted in case of emergency
    - Is a family member or work associate (secretary, nurse, technician,…) of the Investigator
    - Mentally unable to understand the nature, objectives and possible consequences of the trial; or refusing to subject himself / herself to its constraints
    - Has forfeited his/her freedom by administrative or legal award or is under guardianship
    E.5 End points
    E.5.1Primary end point(s)
    The primary criterion is the response to treatment defined as an average decrease from baseline, i.e. the last week before inclusion, of at least 30% on the 24-hour recall pain intensity score recorded on a Numeric Rating Scale by electronic diary within the last week before the end of treatment (D84 or premature withdrawal for any reason other than lack of efficacy); patients in whom the average daily dose of the intake of rescue medication during the last week before the end of treatment has increased by 15% or more compared to the last week before inclusion, will be considered as non responders.
    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 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 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.8.3 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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months16
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months16
    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) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 124
    F.4.2.2In the whole clinical trial 124
    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 Decision2007-08-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-05-18
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