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    Summary
    EudraCT Number:2013-001511-70
    Sponsor's Protocol Code Number:44313
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-09-06
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-001511-70
    A.3Full title of the trial
    Efficacy, safety and tolerability of lacosamide in patients with gain-of-function Nav1.7 mutations related small fiber neuropathy:
    a randomized, double-blind, placebo controlled, crossover trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy, safety and tolerability of lacosamide in patients with small fiber neuropathy with a mutation in sodiumchannel 1.7:
    a randomized, double-blind, placebo controlled, crossover trial
    A.3.2Name or abbreviated title of the trial where available
    MaYa-Nav1.7 study
    A.4.1Sponsor's protocol code number44313
    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 SponsorMaastricht University Medical Center
    B.1.3.4CountryNetherlands
    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 supportPrinses Beatris Spierfonds
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMaastricht University Medical Center
    B.5.2Functional name of contact pointDepartment of neurology
    B.5.3 Address:
    B.5.3.1Street AddressPO-Box 5800
    B.5.3.2Town/ cityMaastricht
    B.5.3.3Post code6202 AZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31433877059
    B.5.5Fax number+31433877055
    B.5.6E-mailkim.bekelaar@mumc.nl
    D. IMP Identification
    D.IMP: 1
    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 Vimpat
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Pharma SA
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameVimpat
    D.3.2Product code SUB25407
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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) 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
    SCN9A mutation related small fiber neuropathy
    E.1.1.1Medical condition in easily understood language
    Disease of small nerve fibers related to a mutation in the SCN9A gene
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    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 of this study is to evaluate the efficacy of lacosamide versus placebo in subjects with SCN9A-associated SFN.
    E.2.2Secondary objectives of the trial
    •To evaluate effect on maximum pain of subjects treated with lacosamide versus placebo.
    •To evaluate effect on neuropathic pain quality in subjects treated with lacosamide versus –placebo.
    •To evaluate subject – reported sleep interference due to pain in subjects treated with lacosamide versus placebo.
    •To evaluate subject’s global impression of change in subjects treated with lacosamide versus placebo.
    •To determine the effect of lacosamide versus placebo on autonomic symptoms in SCN9A-associated SFN.
    •To determine the effect of lacosamide versus placebo on health-related quality of life (HQoL).
    •To evaluate the safety and tolerability of lacosamide in subjects with SCN9A-associated SFN.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and/or female subjects between the ages of 18 and 78 years.
    2. Presence of a clinical diagnosis of Small Fiber Neuropathy (SFN) for at least 3 months prior to Screening, with at least 2 of the following clinical symptoms:
    • Burning feet.
    • Allodynia.
    • Diminished pain and/or temperature sensation.
    • Dry eyes or mouth.
    • Orthostatic dizziness.
    • Bowel disturbances (constipation, diarrhea, gastroparesis).
    • Urinary disturbances.
    • Sweat changes (hyper-/hypohidrosis).
    • Visual accommodation problems and/or blurred vision.
    • Hot flashes/palpitations.
    • Impotence, diminished ejaculation or lubrication.
    3. In addition to the clinical diagnosis of SFN, presence of confirmed abnormality on intra-epidermal nerve fiber density evaluation (IENFD) and/or Quantitative Sensory Testing (QST) and a mutation in the SCN9A gene, confirmed by sequencing. Where possible, in vitro confirmation of the functionality of the mutation should have been performed and documented.
    4. Presence of pain due to SFN for at least 3 months prior to Screening and an average self-reported pain score of at least 3 during this time.
    5. If on analgesic medication to manage pain due to SFN, subject must have stable analgesic medication for a minimum of 30 days prior to the start of the study and should continue with the same regimen throughout the study.
    6. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
    7. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    E.4Principal exclusion criteria
    1. Subjects with predominantly signs of large nerve fiber involvement (muscle weakness, loss of vibration sense, hypo-/-areflexia), clinically significant abnormal nerve conduction studies (NCS).
    2. History or presence of illnesses known to cause SFN (excluding diabetes mellitus), including liver, kidney or thyroid dysfunction, monoclonal gammopathy, connective tissue disorders, sarcoidosis, Sjogren syndrome, amyloidosis, Fabry disease, celiac disease, HIV and neurotoxic drugs (e.g., chemotherapy).
    3. Subjects with other severe pain conditions which may impair the self-assessment of pain due to SFN.
    4. Any condition possibly affecting drug intake and absorption (e.g., difficulty in swallowing, gastrectomy and /or bowel resection).
    5. History of known alcohol, analgesic or illicit drug abuse within 12 months of Screening.
    6. Subjects taking medications with activity at sodium channels e.g., lamotrigine, carbamazapine, oxcarbazapine, mexiletine, amitriptyline, topical analgesics e.g., lidocaine patches, capsaicin patches and oral/injectable corticosteroids. These medications are prohibited until the end of the study period and require a washout period of at least 5 half lives (90 days for capsaicin patches) prior to the Screening visit.
    7. 12-lead ECG demonstrating QTcF (Fridericia’s correction) >450 or a QRS interval >120 msec at Screening. If QTcF exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTcF values should be used to determine the subject’s eligibility.
    8. Severe renal impairment (creatinine clearance ≤ 30 mL/min).
    9. Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
    10. Participation in other studies during the period of current study participation, or has planned surgery during the course of the study.
    11. Pregnant females; breastfeeding females; females of childbearing potential not using effective contraception or not agreeing to continue effective contraception for at least 28 days after the last dose of investigational product.
    12. Other clinically significant or unstable, or severe acute or chronic medical or psychiatric/psychological condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in the average pain score as measured using a Pain Intensity Numerical Rating Scale [PI-NRS], an 11-point numerical scale where 0 = no pain and 10 = worst possible pain.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The subject will be asked to complete the PI-NRS twice daily, it will be evaluated at each visit or telephone call and at the end of the study.
    E.5.2Secondary end point(s)
    •Maximum Pain Score on the PI-NRS.
    •Neuropathic Pain Scale (NPS).
    •Daily Sleep Interference Scale (DSIS).
    •Patient Global Impression of Change (PGIC).
    •Small Fiber Neuropathy Symptoms Inventory questionnaire (SFN-SIQ).
    •Generic short-form SF-36 health survey (SF-36).
    •Adverse Events, Laboratory Safety Tests (Hematology, Clinical Chemistry, Urinalysis), Blood Pressure, Pulse Rate, ECG
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondairy outcomes will be evaluated at each visit or telephone call and at the end of the study.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    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.8.2.4Number 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.8.5The 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 years1
    E.8.9.1In the Member State concerned months
    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) Yes
    F.1.2.1Number of subjects for this age range: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state20
    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)
    If patients experience good effect of medication, lacosamide can be used off-label as a treatment against neuropathic pain.
    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 Decision2015-08-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-08-21
    P. End of Trial
    P.End of Trial StatusCompleted
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