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    Summary
    EudraCT Number:2014-005548-17
    Sponsor's Protocol Code Number:69HCL14-0438
    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:2015-06-03
    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 ConcernedFrance - ANSM
    A.2EudraCT number2014-005548-17
    A.3Full title of the trial
    TREATMENT OF PENDULAR NYSTAGMUS WITH GABAPENTIN AND MEMANTINE IN PATIENTS WITH MULTIPLE SCLEROSIS or OCULOPALATAL TREMOR:
    A CONTROLED OPEN-LABEL STUDY
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    TREATMENT OF PENDULAR NYSTAGMUS WITH GABAPENTIN AND MEMANTINE IN PATIENTS WITH MULTIPLE SCLEROSIS or OCULOPALATAL TREMOR:
    A CONTROLED OPEN-LABEL STUDY
    A.4.1Sponsor's protocol code number69HCL14-0438
    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 SponsorHOSPICES CIVILS DE LYON
    B.1.3.4CountryFrance
    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 supportHOSPICES CIVILS DE LYON
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHOSPICES CIVILS DE LYON
    B.5.2Functional name of contact pointZUBLENA
    B.5.3 Address:
    B.5.3.1Street Address3 quai des Celestins
    B.5.3.2Town/ cityLYON
    B.5.3.3Post code69002
    B.5.3.4CountryFrance
    B.5.4Telephone number04 72 40 68 46
    B.5.5Fax number04 72 11 51 90
    B.5.6E-mailirene.zublena@chu-lyon.fr
    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 NEURONTIN
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER HOLDING FRANCE
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameGabapentine
    D.3.2Product code N03AX12
    D.3.4Pharmaceutical form Capsule
    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.3.9.1CAS number 60142-96-3
    D.3.9.3Other descriptive nameGABAPENTIN
    D.3.9.4EV Substance CodeSUB07857MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 EBIXA
    D.2.1.1.2Name of the Marketing Authorisation holderH. Lundbeck A/S
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameMEMANTINE
    D.3.2Product code N06DX01
    D.3.4Pharmaceutical form Coated 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 INNMEMANTINE
    D.3.9.1CAS number 19982-08-2
    D.3.9.4EV Substance CodeSUB08731MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    PENDULAR NYSTAGMUS IN PATIENTS WITH MULTIPLE SCLEROSIS OR OCULOPALATAL TREMOR
    E.1.1.1Medical condition in easily understood language
    PENDULAR NYSTAGMUS IN PATIENTS WITH MULTIPLE SCLEROSIS OR OCULOPALATAL TREMOR
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10029864
    E.1.2Term Nystagmus
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the effect of gabapentine and memantine on nystagmus in a OPT patients population and a MS population.
    E.2.2Secondary objectives of the trial
    To compare the effect of gabapentine and memantine on nystagmus in a OPT patients population versus a MS patients population.
    To describe the tolerance of the investigational drugs in OPT and MS patients.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients may have either
    o a diagnosis of oculopalatal tremor (OPT), following a focal brainstem lesion.
    o a clinically definite, laboratory-supported diagnosis of MS according to the Mac Donald criteria
    - All patients may present a chronic acquired pendular nystagmus due to OPT or MS, observed over a period of 6 months.
    - All patients will be informed about the design and purpose of the study, and all will give their informed, written consent to the protocol, which may have been approved by the local ethics committee.
    - Age: above 18
    - Able to understand the instructions
    - Having a health coverage
    - Able to sit down for 1 hour
    - Stable dosage of previous medications (beginning 3 weeks previously and terminating at the end of the trial duration), except gabapentin or memantine
    E.4Principal exclusion criteria
    - Ophthalmological
    o Other ophthalmological disorder that could impair corrected visual acuity (Maculopathy, Retinopathy…)
    - Neurological
    o Ongoing seizure
    o Severe handicap that does not allow sitting down position for 1 hour
    - Suicidal behavior or risk
    - Treatment
    o Under memantine or gabapentin medication (these medications should have been stopped for at least 1 week for gabapentin and 3 weeks for memantine)
    o Under morphine, N-methyl-D-aspartate such as amantadine, ketamine or dextromethorphan
    o Steroid medication for a current relapse (beginning 3 weeks previously and terminating at the end of the trial duration
    o Known hypersensitivity to memantine or gabapentin
    - General
    o Unstable medical state
    o Patient with a galactose intolerance, a lapp lactase deficiency or glucose-galactose malabsorption
    o Moderate renal failure (creatinine clearance < 50 mL/min on bioassay dated from less than one month)
    o Recent heart infarction (<3months)
    o Unstable congestive heart insufficiency
    o Unstable arterial hypertension
    o Leucopenia (<2500/mm3)
    o Transaminase increase (>5 time normal values)
    - Pregnancy (on questioning)
    - Tutelage or any legal protection measure
    E.5 End points
    E.5.1Primary end point(s)
    Clinical examination :All patients undergo a thorough ophthalmic examination including fundi and best corrected visual acuity measurement

    Eye movement recording :A quantitative recording of eye position for each eye is performed in all patients in using a 3D infrared video-oculography (25 Hz frequency) and a 2D infrared video-oculagraphy (100 Hz) (Synapsys®, Marseille, France).

    Eye movements analysis:Based on the trajectories of each eye projected in the three planes the following values are extracted:
    • The dominant plane (H, V or T) as the plane in which the largest amplitude of eye oscillation was measured.
    • The mean amplitude and the mean peak velocity calculated on 20 consecutive cycles of nystagmus in the dominant plane.
    • The frequency of pendular nystagmus, manually calculated over a 30 sec period. For the purpose of analyzing more precisely the frequency of nystagmus, we also perform a Fast Fourier Transform of 2D eye position data (100 Hz frequency recording)


    VFQ-25 :To examine vision-specific health-related quality of life we use the 25-Item National Eye Institute Visual Function Questionnaire (VFQ-25), which has been validated in patients with optic neuritis (Ma, Shea et al. 2002).

    Oscillopsia measurement :Patients will estimate monocularly and binocularly the direction and amplitude of their oscillopsia while viewing, with best correction, a stationary target at far (5 m) and near (57 cm) location.

    Tolerance :Tolerance of medications and side effects will be recorded.
    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 No
    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 No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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.8.4.1Number of sites anticipated in Member State concerned1
    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
    LVLS
    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 months8
    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) 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) Information not present in EudraCT
    F.1.3Elderly (>=65 years) Information not present in EudraCT
    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 state20
    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 Decision2015-03-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-28
    P. End of Trial
    P.End of Trial StatusCompleted
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