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    The EU Clinical Trials Register currently displays   43935   clinical trials with a EudraCT protocol, of which   7309   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    EudraCT Number:2014-000418-75
    Sponsor's Protocol Code Number:TV5600-CNS-20007
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-09-25
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedPortugal - INFARMED
    A.2EudraCT number2014-000418-75
    A.3Full title of the trial
    A Multicenter, Multinational, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Laquinimod (0.5, 1.0 and 1.5 mg/day) as Treatment in Patients with Huntington's Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study in subjects with Huntington's Disease to assess the efficacy and safety of three oral doses of laquinimod, either 0.5 mg/day, 1.0 mg/day or 1.5 mg/day (experimental drug)
    A.3.2Name or abbreviated title of the trial where available
    LEGATO-HD (Laquinimod Efficacy and Safety in a GlobAl Trial Of HD)
    A.4.1Sponsor's protocol code numberTV5600-CNS-20007
    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 SponsorTeva Branded Pharmaceutical Products R&D, Inc.
    B.1.3.4CountryUnited States
    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 supportTeva Branded Pharmaceutical Products R&D, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTeva GmbH
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressGraf-Arco-Str.3
    B.5.3.2Town/ cityUlm
    B.5.3.3Post code89079
    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 nameLaquinimod capsules 0.5 mg
    D.3.2Product code TV-5600
    D.3.4Pharmaceutical form Capsule, hard
    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 INNLAQUINIMOD
    D.3.9.1CAS number 248282-07-7
    D.3.9.2Current sponsor codeTV-5600, ABR-215062 sodium salt
    D.3.9.3Other descriptive name5-Chloro-1,2-dihydro-N-ethyl-4-hydroxy-1-methyl-2-oxo-N-phenyl-3-quinolinecarboxamide sodium
    D.3.9.4EV Substance CodeSUB25236
    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) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    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
    Huntington's Disease (HD)
    E.1.1.1Medical condition in easily understood language
    Huntington's disease is a hereditary disorder causing degeneration of neurons in the brain that affects muscle coordination and leads to cognitive decline and emotional disturbance
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10070668
    E.1.2Term Huntington's disease
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to assess the efficacy of laquinimod (1.0 mg qd) in patients with HD after 12 months of treatment using the UHDRS-TMS.
    E.2.2Secondary objectives of the trial
    Secondary study objectives:
    • To assess the effect of laquinimod (1.0 mg qd) on brain atrophy in patients with HD after 12 months of treatment using MRI measures of caudate volume

    Safety and Tolerability Study Objectives:
    • To evaluate safety and tolerability of laquinimod in patients with HD during 12 months of treatment by evaluating adverse events, electrocardiography, and clinical laboratory parameters, vital signs, physical examinations, and premature discontinuations from the study

    Exploratory Study Objectives: see study protocol
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacogenomic Sub-Study:
    Pharmacogenomic (PGx) assessment will include DNA variations and RNA,gene expression pattern potentially associated with clinical treatment responses to laquinimod (e.g. clinical effect, Q-Motor, pharmacokinetics, tolerability, and safety features or disease susceptibility and severity features). Samples for DNA analysis will be collected at screening (or if not possible, at the next possible visit). Samples for RNA analysis will be collected at baseline, Month 6 and 12.

    Other Ancillary Studies:
    • Microglial activation state will be investigated in selected patients (N=aiming at 10 per treatment arm). Positron emission tomography (PET) scans and imaging analysis of microglial activation marker translocator protein (TSPO) will be performed at baseline and Month 12.
    • Change in putaminal and frontal white matter markers of neuronal integrity (N-acetylaspartate (NAA)) and astrocytosis (myo-inositol) will be investigated at selected sites using magnetic resonance spectroscopy (MRS) (N=aiming at 20 per treatment arm) at baseline and Month 12.
    • Monocyte gene expression and/or protein profile in response to treatment with laquinimod will be analyzed at selected sites and patients (N=aiming at 25 per treatment arm). Monocytes will be separated from isolated peripheral blood mononuclear cells (PBMC) and be analyzed for gene expression and/or protein profile at baseline and Month 12.
    • Peripheral cytokine and proteomic analysis in response to treatment with laquinimod will be investigated in a subgroup of patients at selected sites at baseline and Months 6 and 12.

    Ancillary Study Objectives (substudies):
    • To explore potential correlation between genetic polymorphisms in deoxyribonucleic acid (DNA) and pharmacokinetics, clinical response to laquinimod, and/or adverse drug reactions, if these occur
    • To explore potential correlation between ribonucleic acid (RNA) expression profile in blood cells and clinical response to laquinimod
    • To evaluate changes in cytokines and other soluble protein levels following treatment with laquinimod as potential biomarkers for laquinimod mechanism of action and/or response predictive factors
    • To explore gene expression and/or protein profile in monocytes in response to laquinimod treatment
    • To explore change in microglial activation state in response to treatment with laquinimod
    • To assess the correlation between microglial activation state at baseline and the clinical characteristics of HD patients (age, gender, number of triplets, disease onset, disease duration, motor and behavioral scores).
    • To explore changes in MRS metabolite levels in response to treatment with laquinimod that reflect neuronal integrity (NAA) and astrocytosis (myo-inositol) in the putamen and frontal white matter.
    E.3Principal inclusion criteria
    Patients may be included in the study if they meet all of the following criteria:
    a. Documentation of prior positive genetic testing for HD, or a clinical diagnosis of symptomatic HD (Diagnostic Confidence Level 4).
    b. Presence of 36-49 CAG repeats, inclusive, in the huntingtin gene based on centralized CAG testing during screening.
    c. Male or female between 21-55 years of age, inclusive, with an onset of HD at or after 18 years of age.
    d. Women of child-bearing potential (women who are not post-menopausal or who have not undergone surgical sterilization) must practice an acceptable method of birth control for 30 days before taking the study treatment, and 2 acceptable methods of birth control during all study duration and until 30 days after the last dose of treatment was administered. Acceptable methods of birth control in this study include: Intrauterine device, barrier method (condom or diaphragm with spermicide) and hormonal methods of birth control (e.g., oral contraceptive, contraceptive patch, long-acting injectable contraceptive).
    e. A sum of >5 points on the UHDRS-TMS at the screening visit
    f. UHDRS- TFC ≥ 8 at the screening visit.
    g. Able and willing to provide written informed consent prior to any study related procedure being performed at the screening visit. Patients with a legal guardian should be consented according to local requirements.
    h. Willing to provide a blood sample for genomic CAG analysis at the screening visit.
    i. Willing and able to take oral medication and able to comply with the study specific procedures.
    j. Ambulatory, being able to travel to the study centre, and judged by the investigator as likely to be able to continue to travel for the duration of the study
    k. Availability and willingness of a caregiver, informant, or family member to provide input at study visits assessing CIBIC-Plus, CDR-SB, PBA-s, and HD-QoL. A caregiver is recommended to be someone who attends to the patient at least 2 to 3 times per week for at least 3 hours per occasion, and the suitability of the caregiver should be judged by the investigator.
    l. For patients taking allowed antidepressant medication, the dosing of medication must have been kept constant for at least 30 days before baseline and must be kept constant during the study.
    E.4Principal exclusion criteria
    Patients are excluded from participating in this study if 1 or more of the following criteria are met:
    a. Use of immunosuppressive agents, or cytotoxic agents, including cyclophosphamide and azathioprine within 12 months prior to screening
    b. Previous use of laquinimod
    c. Use of moderate/strong inhibitors of cytochrome P450 (CYP)3A4 within 2 weeks prior to randomization.
    d. Use of inducers of CYP3A4 within 2 weeks prior to randomization.
    e. Pregnant or breastfeeding.
    f. Serum levels ≥2x upper limit of the normal range (ULN) of either alanine aminotransferase (ALT) or aspartate aminotransferase (AST) at screening.
    g. Serum direct bilirubin which is ≥1.5xULN at screening.
    h. Estimated creatinine clearance <60 mL/min at screening, calculated using the Cockcroft Gault equation: (140 - age) × mass (kg) × [0.85 if female] / 72 × serum creatinine (mg/dL)
    i. Subjects with a clinically significant or unstable medical or surgical condition that may put the patient at risk when participating in the study or may influence the results of the study or affect the patient's ability to take part in the study, as determined by medical history, physical examinations, ECG, or laboratory tests. Such conditions may include:
    1. A major cardiovascular event (e.g. myocardial infarction, acute
    coronary syndrome, de-compensated congestive heart failure,
    pulmonary embolism, coronary revascularization, angina) that occurred prior to randomization.
    2. Significant cardiovascular risk factors (such as, but not limited to,
    uncontrolled hypertension, uncontrolled diabetes), per investigator
    3. Any acute pulmonary disorder
    4. A CNS disorder other than HD that may jeopardize the subject's
    participation in the study, including such disorders that are
    demonstrated on the baseline MRI (based on local read).
    5. A gastrointestinal disorder that may affect the absorption of study medication.
    6. Acute or chronic renal disease including acute kidney injury (AKI).
    7. Any form of acute or chronic liver disease.
    8. Known human immunodeficiency virus positive status. Patients will
    undergo an HIV test at screening per local requirements, if applicable.
    9. Any malignancies, excluding basal cell carcinoma, in the 5 years prior
    to randomization.
    j. Any clinically significant, abnormal, screening laboratory result which in the opinion of the investigator, affects the patients’ suitability for the study or puts the patient at risk if he/she enters the study
    k. Unsuitable for MRI (e.g., claustrophobia, metal implants)
    l. Alcohol and/or drug abuse within the 12 months prior to screening, as defined by Diagnostic and Statistical Manual of Mental Disorders –
    Fourth Edition Text Revision (DSM-IV TR) criteria for substance abuse.
    For former alcohol and/or drug abusers, the abstinence should be
    confirmed by laboratory tests (drug testing and/or carbohydrate
    deficient transferrin (CDT) level in blood).
    m. Patients with active suicidal ideation during the past month as measured by a most severe suicide ideation score of 4 (Active Suicidal Ideation with Some Intent to Act, without Specific Plan) or 5 (Active Suicidal Ideation with Specific Plan and Intent) on the baseline screening Columbia-Suicide Severity Rating Scale (C-SSRS) or subjects who answer “Yes” on any of the 5 C-SSRS Suicidal Behavior Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior) if the attempt or acts were performed within 1 year of screening, or subjects who, in the opinion of the investigator, present a serious risk of suicide.
    n. Patients with known intracranial neoplasms, vascular malformations, or intracranial hemorrhage
    o. Known drug hypersensitivity that would preclude administration of laquinimod or placebo, such as hypersensitivity to mannitol, meglumine or sodium stearyl fumarate.
    p. Swallowing difficulties that would preclude administration of laquinimod or placebo capsules.
    q. Treatment with any investigational product within 30 days of
    screening or patients planning to participate in another clinical study
    assessing any investigational product during the study.
    Patients in non-interventional and/or observational studies will not be
    excluded from participating in this study.
    r. Treatment with tetrabenazine within 30 days of the study baseline
    s. Treatment with antipsychotic medication within 30 days of the study
    baseline visit
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable and endpoint for this study is change from baseline in the UHDRS TMS (defined as the sum of the scores of all UHDRS-TMS subitems) in patients treated with laquinimod (1.0 mg qd) at Month 12/ Early Termination (ET) (evaluated at baseline and Months 1, 3, 6 and 12).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Change from baseline in the UHDRS TMS in patients treated with laquinimod (1.0 mg qd) will be evaluated at Month 12/ ET (evaluated at baseline and Months 1, 3, 6 and 12).
    E.5.2Secondary end point(s)
    The secondary efficacy variable and endpoint for this study is:
    • Percent atrophy from baseline in caudate volume in patients treated with laquinimod (1.0 mg qd) at Month 12/ET (evaluated at baseline and Month 12)

    Exploratory Efficacy Variables and Endpoints:
    The exploratory efficacy variables and endpoints for this study are:
    • Change from baseline in the UHDRS-TMS (defined as the sum of the scores of all UHDRS-TMS subitems) in patients treated with laquinimod (0.5 mg qd) at Month 12/ ET (evaluated at baseline and Months 1, 3, 6 and 12).
    • Percent change from baseline in caudate volume in patients treated with laquinimod (0.5 mg qd) at Month 12/ET (evaluated at baseline and Month 12).
    • Change from baseline in HD-CAB total score (sum of the standardized sub-components) at Month 12/ET (evaluated at baseline and Months 6 and 12).
    • CIBIC-Plus global score at Month 12/ET (evaluated at Months 6 and 12) as compared to baseline (rated by an independent rater).
    • Change from baseline in UHDRS-TFC at Month 12/ET (evaluated at baseline, Months 6 and 12).
    • Change from baseline in brain atrophy as defined by the percentage change in volume in: whole brain volume and white matter volume at Month 12/ET and absolute change in ventricular volume at Month 12/ET (evaluated at baseline and Month 12)
    • Change from baseline in UHDRS- FA at Month 12/ET (evaluated at baseline and Months 6 and 12)
    • Change from baseline in Q-Motor assessments at Month 12/ET (evaluated at baseline and Months 1, 3, 6 and 12)
    • Change from baseline in mPPT at Month 12/ET (evaluated at baseline and Months 6 and 12)
    • Change from baseline in HD QoL and EQ-5D-5L at Month 12/ET (evaluated at baseline and Month 12)
    • Change from baseline in WLQ at Month 12/ET (evaluated at baseline and Month 12)
    • Change from baseline in HD-CAB sub-components at Month 12/ET (evaluated at baseline and Months 6 and 12): Symbol Digit Modalities Test (SDMT), Emotion Recognition, Trail Making Test, Hopkins Verbal Learning Test, revised (HVLT-R), Paced Tapping at 3 Hz, One Touch Stockings of Cambridge (OTS, abbreviated 10 trial version)
    • Change from baseline in CDR-SB at Month 12/ET (evaluated at baseline and Month 12)
    • Change from baseline in HADS at Month 12/ET (evaluated at baseline and Month 12)
    • Change from baseline in PBA-s at Month 12/ET (evaluated at baseline and Month 12)

    Safety Variables and Endpoints:
    Safety variables and endpoints will include the following:
    • Adverse events reports throughout the study
    • ECG findings throughout the study
    • Clinical safety laboratory tests throughout the study
    • Vital signs measurements throughout the study
    • Physical examination findings throughout the study
    • Changes from baseline suicidality (C-SSRS) scores throughout the study

    Tolerability variables and endpoints:
    • Proportion of subjects (%) who prematurely discontinued from the study, reason of discontinuation and the time to ET
    • Proportion of subjects (%) who prematurely discontinued from the study due to AEs and the time to ET
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary Efficacy Variables/Endpoints: Changes from baseline (BL) will be determined at Month 12/ET and evaluated as follows: Caudate volume (BL, Month 12), HD-CAB total score (BL, Months 6 and 12), CIBIC-Plus global score (BL, Months 6 and 12), UHDRS- TFC (BL, Months 6 and 12)

    Exploratory Efficacy Variables/Endpoints: Change from BL will be determined at Month 12/ET and evaluated as follows: Brain atrophy (BL, Month 12), UHDRS- FA (BL, Months 6 and 12), Q-Motor assessments (BL, Months 1, 3, 6 and 12), mPPT (BL, Months 6 and 12), HD QoL/EQ-5D-5L (BL, Month 12), WLQ (BL, Month 12), HD-CAB subcomponents (BL, Months 6 and 12), CDR-SB (BL, Month 12), HADS (BL, Month 12), PBA-s (BL, Month 12)

    Tolerability Variables/Endpoints will be determined at Month 12
    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 Yes
    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. 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.8.2.4Number of treatment arms in the trial3
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA29
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Czech Republic
    Russian Federation
    United Kingdom
    United States
    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 years3
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days0
    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: 330
    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 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 Yes
    F. of subjects incapable of giving consent
    According to the inclusion criteria in the study protocol, patients with a legal guardian can be included and are consented according to local requirements.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 191
    F.4.2.2In the whole clinical trial 330
    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)
    None / standard of care
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Huntington Study Group, Ltd. (HSG)
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation European Huntington Disease Network (EHDN)
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-10-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-06-19
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