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    Summary
    EudraCT Number:2005-002088-98
    Sponsor's Protocol Code Number:AN01.01.0012
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-11-28
    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 ConcernedGermany - BfArM
    A.2EudraCT number2005-002088-98
    A.3Full title of the trial
    Full title of the trial : A multicentre, multi-national, double-blind, randomised, parallel group placebo-controlled trial of ethyl-EPA (ethyl-icosapent) in patients with Huntington’s Disease
    A.4.1Sponsor's protocol code numberAN01.01.0012
    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 SponsorAmarin Neuroscience Ltd
    B.1.3.4CountryUnited Kingdom
    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 Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/00/013
    D.3 Description of the IMP
    D.3.1Product nameEthyl-EPA
    D.3.2Product code LAX-101
    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.3.8INN - Proposed INNEthyl-Icosapent
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number485
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    HUNTINGTON’S DISEASE
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.0
    E.1.2Level LLT
    E.1.2Classification code 10010331
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To examine the effect of ethyl-EPA versus placebo on the motor phenotype of HD patients as measured by the TMS-4 derived from the UHDRS-Total-Motor-Score (TMS) over a period of 6 months.
    E.2.2Secondary objectives of the trial
    To examine the effect of ethyl-EPA versus placebo on Chorea (as measured by the UHDRS-TMS Subscale)over a period of 6 months
    To examine the effect of ethyl-EPA versus placebo on the Total Motor Score component (TMS) of the Unified Huntington’s Disease Rating Scale (UHDRS) over a period of 6 months
    To examine the effect of ethyl-EPA versus placebo on the Clinical Global Impressions (CGI) score over a period of 6 months.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    - Written informed consent.
    - Aged 35 or older of either gender
    - Has clinical features of Huntington’s Disease (HD) and a confirmatory family history of HD, and/or a CAG repeat expansion greater than or equal to 36.
    - Maximal dystonia score of 2 or less in both trunk and extremities items.
    - Chorea score of at least 2 in at least one extremity item.
    - Maximal bradykinesia score of 2 or less in each of the items: body, pronation/supination and finger tapping
    - Able to travel to the assessment centre and judged by the Investigator as likely to be able to continue to travel for the duration of the trial.
    E.4Principal exclusion criteria
    - Unable to give written informed consent.
    - Requires 24 hour care and usually bedridden
    - Unlikely to comply with trial visit schedule or with trial medication due to irritability, symptoms of depression or other reason(s)
    - Diagnosis of major depressive disorder as defined in the DSM-IV-TR
    - Score positive for item A9 on the DSM-IV-TR
    - Severe intercurrent illness which, in the opinion of the Investigator, may put the patient at risk when participating in the trial or may influence the results of the trial or affect the patients’ ability to take part in the trial.
    - Clinically significant, abnormal, baseline laboratory result(s), which in the opinion of the Investigator affect(s) the patients suitability for the trial e.g. abnormal TSH.
    - Females who, in the opinion of the Investigator, have the potential of childbearing but are not taking adequate contraceptive precautions; or who are pregnant or lactating.
    - Alcohol and / or drug abuse as defined in theDSM IV criteria for substance abuse - applies to alcohol and / or any illicit drug, including cannabis within the last 12 months.
    - Omega 3 supplementation within 4 weeks of visit 1 and throughout the trial period.
    - Treatment with tetrabenazine – current or within 4 weeks of visit 1.
    - Treatment with neuroleptics (including atypical neuroleptics) except when taken at a stable dose for 4 weeks or more prior to visit 1
    - Treatment with benzodiazepines on a regular basis within 8 weeks of visit 1, except when used at a low doses for insomnia e.g. valium 5mg, temazepam 10mg, diazepam and lorazepam 1mg at night.
    - Treatment with steroids (other than topical preparations) – current or within 4 weeks of visit 1.
    - Selenium supplementation > 55mcg/day within 4 weeks of visit 1.
    - Magnesium supplementation >150mg/day, riluzole or NMDA antagonists (memantine and amantadine) within 4 weeks of visit 1.
    - Treatment with lithium medication – current or within 6 months of visit 0.
    - Treatment with antiepileptic medication – current or within 6 months of visit 0.
    - Have participated in another interventional clinical trial or taken Investigational Medication in the last 3 months.
    - Have participated in any clinical trial with ethyl-EPA.
    - Known allergy to any ingredients of the trial medication or placebo.
    - Currently taking anticoagulants.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in TMS-4 over 6 months
    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 Information not present in EudraCT
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Amendment 1: Open-label extension
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    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 Information not present in EudraCT
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 240
    F.4.2.2In the whole clinical trial 240
    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 Decision2006-02-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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