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    Summary
    EudraCT Number:2008-001218-26
    Sponsor's Protocol Code Number:TRO19622 CL E Q 1204-1
    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:2008-05-05
    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 number2008-001218-26
    A.3Full title of the trial
    A double blind, placebo controlled study of the effect of 330mg QD of TRO19622 in the treatment of Chemotherapy Induced Peripheral Neuropathy.
    A.4.1Sponsor's protocol code numberTRO19622 CL E Q 1204-1
    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 SponsorTROPHOS SA
    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 TRO19622
    D.3.4Pharmaceutical form Capsule, soft
    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 2203-87-0
    D.3.9.2Current sponsor codeTRO19622
    D.3.9.3Other descriptive name4-cholesten-3-one, oxime
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number165
    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, soft
    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
    Symptoms of chemotherapy induced peripheral neuropathy
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10036109
    E.1.2Term Polyneuropathy due to drugs
    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 effect of TRO19622 on peripheral neuropathy scores after 6 weeks treatment and based on the separate assessment of pain and dysesthesia scores
    E.2.2Secondary objectives of the trial
    - Compare the efficacy on Neuropathic Pain Inventory Score on Dysgueusia if present ,Quality of life, Quantitative Sensory Testing , ENMG,safety profil, pain time course of TRO19622 versus placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Be a male >18 years or a female with adequate contraception if of child bearing potential.
    - Have paclitaxel (or other taxane) induced peripheral neuropathy assessed by the presence of a NCI-CTC version 2 neuropathy sensory grade ≥2 .
    - Peripheral neuropathy as clinically diagnosed during the neurological examination including sensitivity, motor function and deep tendon reflex assessments
    - With symptoms of:
    • Neuropathic pain as assessed by the presence of measurable pain perception (previous 24h) on the Likert numerical rating scale ≥4 points at the screening visit and confirmed on DN4 with a score ≥ 4.
    and/or
    • Dysesthesia as assessed by the presence of measurable dysesthesia (previous 24h) on the Likert numerical rating scale ≥ 4 points at the screening visit
    - Persistent neuropathy for at least 3, but no more than 12 months after the end of chemotherapy.
    - Be either pain treatment naive or have important side effects or inadequate relief from their current pain medication (stable over last month).

    The following inclusion criteria should be ascertained at the baseline visit:
    1. Peripheral neuropathy symptoms:
    • Have measurable pain perception (previous 24h) on the Likert numerical rating scale with a mean 4 ≥ points calculated from at least 4 daily measurements over the 7 days immediately prior to the Baseline Visit and/or
    • Dysesthesia as assessed by the presence of measurable dysesthesia with a mean ≥ 4 points calculated from at least 4 daily measurements over the 7 days immediately prior to the Baseline Visit.
    2. Have an electrocardiogram (ECG) at Baseline without any clinically significant abnormality.
    3. Have an expected survival rate of > 6 months.
    E.4Principal exclusion criteria
    1. Related to neuropathic pain
    a) Have a documented neuropathy or risk factors of neuropathy which might interfere
    with the assessment of the severity of pain (eg, including, but not limited to, type 2 diabetes,peripheral vascular disease, B12 Vitamin deficiency, thyroid dysfunction, post surgical neuropathic pain, post-traumatic neuropathy, or neuropathy in relation with disease progression).
    b) Have other neurological diseases that may produce weakness, sensory loss, or autonomic symptoms, or laboratory test abnormality.
    c) Refractory to treatment defined as not improved , according to the investigator,by 3 or more treatments prescribed for the current PN symptoms.

    2. Related to efficacy and safety evaluation
    a) HIV positive serology.
    b) History of, or current cardiac dysrhythmias and / or a history of cardiovascular disease,including myocardial infarction, except patients with only well controlled hypertension.
    c) Have had prior (within the past 6 months) or have concurrent neurotoxic drugs (e.g., but not limited to, docetaxel, cisplatin, vincristine, vinblastine, cytarabine, thalidomide, bortezomib, or procarbazine, capecitabine, navelbine).
    d) Have a current medication that may have a similar mechanism of action as TRO19622:acetyl-L-carnitine
    e) Have a current medication that could interfere with TRO19622 pharmacokinetics: tamoxifene
    f) Have current medications that could interfere with TRO19622 absorption such as ezetimibe,bile salts chelators, fibrates, phytosterols, fish oils.
    g) Have a current medication of lipid lowering agents other than statins.
    h) Have a recent history (within the previous 6 months) or current evidence of alcohol or drug abuse.
    i) Have concurrent unstable disease involving any system (eg, advanced carcinoma other than carcinoma justifying the recent treatment with taxanes, myocardial infarction, clinical or ECG signs of myocardial ischemia, cardiac insufficiency, anginal symptoms, current symptoms of CAD, renal impairment, or any other condition that in the opinion of the Investigator would make the patient unsuitable for study participation)
    j) Be pregnant female or lactating.
    k) Have renal impairment defined as blood creatinine > 1:5 x upper limit of normal (ULN)
    l) Hemostasis disorders or current treatment with oral anticoagulants.
    m) Have hepatic impairment hepatic function as follows: liver enzymes (ALT and AST) > 2 x ULN or > 3:5 x ULN in case of liver metastatis
    n) Are not able to comply with regard to the known contraindications, warnings and precautions,drug-interactions and dosing recommendations of paracetamol or tramadol.
    o) Be possibly dependent on the Investigator or the Sponsor (eg, including, but not limited to, affiliated employee).
    p) Participated in any other investigational drug or therapy study with a non approved medication, within the previous 3 months.
    q) Known hypersensitivity to one of the capsules’ ingredients
    r) Any other condition which, in the opinion of the investigator would impede competence or compliance or possibly hinder completion of the study.
    E.5 End points
    E.5.1Primary end point(s)
    Effect will be measured on the percentage of responders defined as patients with a minimum decrease of 50% of their maximum neuropathic pain dimension (either pain or dysesthesia) present at baseline.
    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 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 Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    unbalanced randomisation 5 verum/ 3 placebo
    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 concerned10
    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 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
    Primary efficacy criteria will be measured after 6 weeks of treatment and optional double-blind continuation study will be possible for another 6 weeks
    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 months10
    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 Information not present in EudraCT
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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.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)
    After the end of the 6 weeks double-blind treatment period , patients may continue with a double-blind optional treatment for another 6 weeks .
    Maximum study duration will be 13 weeks
    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 Decision2008-06-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-09-20
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