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    Summary
    EudraCT Number:2008-001999-67
    Sponsor's Protocol Code Number:DRI10566
    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:2009-02-03
    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 number2008-001999-67
    A.3Full title of the trial
    A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients with Multiple Sclerosis
    A.4.1Sponsor's protocol code numberDRI10566
    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 Sponsorsanofi-aventis Recherche & Développement
    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.3.1Product nameNerispirdine hydrochloride
    D.3.2Product code HP184
    D.3.4Pharmaceutical form Film-coated tablet
    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.3.8INN - Proposed INNNerispirdine hydrochloride
    D.3.9.1CAS number 119229-64-0
    D.3.9.2Current sponsor codeHP184
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 placeboFilm-coated tablet
    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
    Multiple Sclerosis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 11.0
    E.1.2Level LLT
    E.1.2Classification code 10028245
    E.1.2Term <Manually entered code. Term in E.1.1>
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to assess the activity of nerispirdine in improving ability to walk, defined as a consistent improvement in walking speed as measured by the Timed 25-Foot Walk (T25-FW) in patients with MS.
    E.2.2Secondary objectives of the trial
    •To assess other measures of efficacy such as the MSWS-12, MFIS, LEMMT, MAS, SGI, and CGI
    •To assess the safety and tolerability of nerispirdine
    •To evaluate the pharmacokinetic (PK) parameters of nerispirdine and its active metabolite, HP183
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Clinically definite MS (McDonald criteria), which includes patients with remitting-relapsing, secondary progressive, progressive-relapsing, or primary progressive MS AND walking disability due to MS (untreated or treated with a stable regimen of a marketed compound for treatment of MS, limited to beta interferons or glatiramer acetate). MS type (relapsing-remitting, secondary progressive, primary progressive, or progressive relapsing) will be determined by the Investigator based on the AAN Practice Guidelines and Tools (http://www.aan.com/go/practice/guidelines) and reference 1 provided in the protocol.
    2. Signed Informed Consent form
    E.4Principal exclusion criteria
    Methodology-related
    1. Patient who is able to walk 25 feet in less than 8 seconds or subject who takes more than 45 seconds (for any of the 2 allowed trials) to walk 25 feet with or without an assistive device during the T25-FW assessment at V1-V4 (before randomization). Patients without valid V1, V2, and V4 T25-FW measurements are not eligible for randomization.
    2. Multiple sclerosis exacerbation or clinical relapse within 6 months prior to the screening visit (V1) or change in regimen or type of MS treatment during the last 3 months, or start of MS disease-modifying therapies within the 3 months prior to screening.
    3. Age <18 years
    4. Patients who participated in any previous nerispirdine (HP184) trials
    5. Patients who were previously exposed to 3,4-diaminopyridine or 4-aminopyridine (4-AP, fampridine, Fampridine-SR)
    6. Patients with current active psychiatric disorders including but not limited to active psychosis, exacerbation of schizophrenia, bipolar disorder, obsessive-compulsive disorder, major depressive disorder, anxiety disorder, and alcohol or substance abuse or dependence (except nicotine)
    7. Use of any investigational drug within 30 days or 5 half-lives whichever is longer
    8. Patient is the Investigator or any Subinvestigator, Research Assistant, Pharmacist, Study Coordinator, other staff or relative thereof directly involved in the conduct of the protocol/study
    9. Patients who are unable to participate for the entire duration of the study, or in the opinion of the Investigator, are likely to be non-compliant with the obligations inherent in the clinical trial participation
    10. Any clinically meaningful or unexplained laboratory abnormality(ies); clinically significant or unstable condition(s) or comorbidities; acute or chronically progressive medical or surgical disorder(s) other than MS which may interfere with walking and may affect patient safety (see Appendix L of the protocol)
    Patients with confirmed neutropenia (neutrophils < 1500/mm3 or according to ethnic group), thrombocytopenia (platelets < 100 000/ mm3), increase in aminotransferases (either ALT [SGPT] or AST [SGOT] >3 ULN and CPK normal) or creatinine clearance < 50 mL/min cannot be randomized (see Appendix L specifying criteria for discontinuation of IP).

    -Nerispirdine-related based on current knowledge on the compound
    11. Criteria to reduce reproductive risk:
    Breastfeeding and pregnant females cannot be included in a clinical study testing nerispirdine. Male subjects who are sexually active with a pregnant female should not participate in the study. Also, patients wishing to breastfeed or parent a child during the course of the study must not participate.
    Women of childbearing potential (WOCBP) as defined in the protocol or male patients not using an effective contraceptive method as described in the protocol cannot be included in clinical studies testing nerispirdine. Women of childbearing potential, who are unwilling to or unable to be tested for pregnancy at study entry and at each clinic visit, or who experience an unexpected delay of menses cannot participate in the study. The pregnancy test to be used in this study is a serum pregnancy test (β-HCG), and not an urine pregnancy test. This test will be performed at each visit.
    If, during any nerispirdine study, a female subject becomes pregnant or decides to attempt to become pregnant or if a male subject decides to attempt to father a child, then she or he must stop the study drug immediately. If a female subject becomes pregnant during the study, then the Investigator must work with sanofi-aventis to deliver appropriate reporting, and follow up as per the study protocol and ICH guidelines.
    “Women NOT of Child Bearing Potential,” as defined in the protocol, do not have to use any method of contraception during a study.
    Women of childbearing potential willing to participate in the study must agree that they will take means to reduce reproductive risk up to 2 weeks after the end of treatment, by agreeing to use a double (dual) method of contraception as needed and described in the protocol.
    Male subjects willing to participate in the study must agree that they will take means to reduce reproductive risk up to 2 weeks after the end of treatment, by agreeing to use a double (dual) method of contraception, as needed and described in the protocol, and to reduce risk to potentially expose fetus to the drug through vaginal absorption.
    E.5 End points
    E.5.1Primary end point(s)
    • Responder criterion, based on consistency of improved response in walking speed on the T25-FW
    A responder is defined as one whose last T25-FW measurement on-treatment and at least 2 other T25-FW measurement on-treatment are faster than the fastest speed recorded during any of the 3 “off drug” visits V2 to V4 before double-blind treatment and the 1 at the end of the 2-week placebo run-out period. All other randomized patients are defined 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 Yes
    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 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 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 Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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 months12
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months5
    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 state64
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 186
    F.4.2.2In the whole clinical trial 368
    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 Decision2009-02-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-03-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-03-02
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