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    Summary
    EudraCT Number:2005-004334-41
    Sponsor's Protocol Code Number:LAQ/5063
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-03-01
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2005-004334-41
    A.3Full title of the trial
    An active extension of LAQ/5062 study. A multinational, multi-center, randomized, double-blind, parallel-group study, to evaluate the safety, tolerability and efficacy of two doses (0.3mg and 0.6mg) of laquinimod, orally administered in relapsing remitting (R-R) Multiple Sclerosis (MS) subjects (study LAQ/5063 active double-blind phase) followed by an open label phase of laquinimod 0.6 mg daily (LAQ/5063 OL).
    Estensione dello studio LAQ/5062. Studio multinazionale, multicentrico, randomizzato, in doppio cieco, con gruppi paralleli di valutazione dell efficacia, della tollerabilita` e della sicurezza di due dosaggi (0.3 mg e 0.6 mg) di Laquinimod somministrato per via orale in pazienti affetti da Sclerosi Multipla (SM) con fasi d esacerbazione e remissione (R-R) (studio LAQ/5063 fase attiva in doppio cieco) seguita da una fase in aperto con laquinimod 0.6 mg somministrato una volta al giorno (LAQ/5063 OL).
    A.4.1Sponsor's protocol code numberLAQ/5063
    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 Pharmaceutical Industries Ldt
    B.1.3.4CountryIsrael
    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 nameLaquinimod
    D.3.2Product code ABR-215062
    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 codeABR-215062 sale di sodio
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number.6
    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
    Relapsing Remitting Multiple Sclerosis
    Sclerosi Multipla con esacerbazioni e remissioni
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting multiple sclerosis
    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 make treatment with laquinimod available to all subjects who previously participated in both LAQ/5062 study and the LAQ/5063 active double-blind phase (completion of the full 36 weeks or as requested by the Sponsor). To assess the long-term safety, and tolerability in the group that received active treatment in LAQ/5062 protocol and additional short term safety and tolerability in the group who received placebo treatment. LAQ/5063 OL phase will assess long-term safety and tolerability of 0.6 mg laquinimod once daily.
    Rendere disponibile il trattamento con Laquinimod a tutti i pazienti che hanno partecipato allo studio LAQ/5062 e alla fase attiva in doppio cieco LAQ/5063 (completamento delle 36 settimane o come richiesto dallo Sponsor). Valutare, a lungo termine, sicurezza, tollerabilita` nel gruppo che ha ricevuto il trattamento attivo nel protocollo LAQ/5062 e un`ulteriore valutazione a breve termine della sicurezza e tollerabilita` nel gruppo che ha ricevuto il trattamento con placebo. La fase LAQ/5063 OL valutera` sicurezza e la tollerabilita` a lungo termine di 0.6 mg laquinimod somministrato una volta al giorno.
    E.2.2Secondary objectives of the trial
    Further efficacy data will be obtained by comparing baseline to termination in the group who received placebo treatment in LAQ/5062 core study protocol.
    Ulteriori dati di efficacia saranno ottenuti confrontando il basale verso il finale nel gruppo che ha ricevuto il trattamento con placebo nel protocollo principale iniziale LAQ/5062.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects must have completed the 36 weeks of treatment (completion of the full 36 weeks or as requested by the Sponsor), of the active double-blind phase. 2. Women of child- bearing potential must practice a reliable method of birth control. (Acceptable methods of birth control in this study include: double barrier methods such as diaphragms with spermicide, condoms and spermicide. Also intrauterine devices; hormonal contraception must be accompanied by an additional method of birth control.). 3. Subjects must be willing and able to comply with the protocol requirements for the duration of the open-label phase (LAQ/5063 OL). 4. Subjects must give signed, written informed consent prior to entering the openlabel phase (LAQ/5063 OL). Inclusion Criteria for the LAQ/5063 OL open-label phase - further extension (after visit month 24) a. Subjects must have completed the 24 months of treatment of the first period of the open label phase. b. Women of child- bearing potential must practice a reliable method of birth control. (Acceptable methods of birth control in this study include: double barrier methods such as diaphragms with spermicide, condoms and spermicide. Also intrauterine devices; hormonal contraception must be accompanied by an additional method of birth control).
    1. Pazienti che abbiano completato le 36 settimane di trattamento (completamento delle 36 settimane o come richiesto dallo Sponsor) della fase attiva in doppio cieco 2. Donne in eta` fertile devono utilizzare un metodo contraccettivo accettabile. (I metodi contraccettivi accettabili in questo studio includono: doppi metodi di barriera come diaframma e crema spermicida, preservativo e crema spermicida. Anche sitemi intrauterini; contraccezione ormonale deve essere accompagnata da un ulteriore metodo contraccettivo) 3. I pazienti devono essere idonei ed in grado di aderire alle richieste del protocollo per tutta la durata della fase in aperto dello studio (LAQ/5063 OL) 4. I pazienti devono essere in grado di fornire il proprio Consenso Informato per iscritto, prima dell inclusione nella fase in aperto dello studio (LAQ/5063 OL). Criteri di inclusione per la fase in aperto dello studio (LAQ/5063 OL) - ulteriore estensione (dopo visita mese 24) a. I pazienti devono aver completato i 24 mesi di trattamento del primo periodo della fase in aperto b. Donne in eta` fertile devono utilizzare un metodo contraccettivo accettabile. (I metodi contraccettivi accettabili in questo studio includono: doppi metodi di barriera come diaframma e crema spermicida, preservativo e crema spermicida. Anche sitemi intrauterini; contraccezione ormonale deve essere accompagnata da un ulteriore metodo contraccettivo)
    E.4Principal exclusion criteria
    Premature discontinuation from LAQ/5063 active double-blind phase for any reason other than sponsor`s request 2. Pregnancy or breastfeeding 3. Subjects with clinically significant or unstable medical or surgical condition, detected or worsened during the active double-blind phase of LAQ/5063, which would preclude safe and complete study participation 4. Use of experimental drugs, immunosuppressive drugs, and/or participation in clinical studies within the period from termination of LAQ/5063 active doubleblind phase to the open-label phase (LAQ/5063 OL) 5. Previous treatment with immunomodulators with the exception of laquinimod (including IFN 1a and 1b, Glatiramer Acetate and IVIG) within 2 months prior to entering the open-label phase for those subjects who have a time gap between termination of LAQ/5063 active double-blind phase to the open-label phase (LAQ/5063 OL) 6. Use of corticosteroids within 30 days prior to entering the open-label phase, except for IV methylprednisolone 1 g/day for a maximum of 3 days, in the period from termination of LAQ/5063 active double-blind phase to the openlabel phase (LAQ/5063 OL) 7. Use of potent inhibitors of CYP3A4 within 2 weeks prior to open label phase (LAQ/5063 OL) and/or use of fluoxetine one month prior entering the open label phase (LAQ/5063 OL), in the period from termination of LAQ/5063 active double-blind phase to the open-label phase (LAQ/5063 OL) (see list in appendix 5) 8. Use of the following substrates of CYP1A2: theophylline and/or warfarin within 2 weeks prior to entering the open-label phase (LAQ/5063 OL), in the label phase (LAQ/5063 OL) 9. Use of amiodarone in the period from termination of LAQ/5063 active doubleblind phase to the open-label phase (LAQ/5063 OL) 10. Following the switch to new formulation (capsules), hypersensitivity to: mannitol, meglumine or sodium stearyl fumarate. Exclusion Criteria for the LAQ/5063 OL open-label phase- further extension (after visit month 24) a. Premature discontinuation from LAQ/5063 OL phase prior to completion of 24 months of treatment period b. Pregnancy or breastfeeding.
    1. Interruzione prematura dalla fase attiva in doppio cieco dello studio LAQ/5063 per qualsiasi motivo diverso da una richiesta dello Sponsor 2. Gravidanza o allattamento 3. Pazienti con patologie mediche o chirurgiche clinicamente significative o instabili, emerse o peggiorate durante la fase attiva in doppio cieco dello studio LAQ/5063, che potrebbero precludere una completa e sicura partecipazione allo studio 4. Utilizzo di farmaci sperimentali, farmaci immunosoppressori e/o partecipazione a studi clinici dal termine della fase attiva in doppio cieco dello studio LAQ/5063 alla fase in aperto (LAQ/5063 OL) 5. Trattamento precedente con immunomodulatori, con l`eccezione di laquinimod (incluso IFN&#946; 1a e 1b, Glatiramer acetato e IVIG), nei 2 mesi precedenti l`entrata nella fase in aperto per quei pazienti che hanno un intervallo tra il termine della fase attiva in doppio cieco dello studio LAQ/5063 e la fase in aperto (LAQ/5063 OL) 6. Utilizzo di corticosteroidi nei trenta giorni precedenti l`entrata nella fase in aperto, eccetto per metilprednisolone IV 1 g/giorno, per un massimo di tre giorni, dal termine della fase attiva in doppio cieco dello studio LAQ/5063 alla fase in aperto (LAQ/5063 OL) 7. Utilizzo di potenti inibitori dell` enzima CYP3A4 nelle 2 settimane precedenti la fase in aperto (LAQ/5063 OL) e/o utilizzo di fluoxetina 1 mese prima dell`entrata nella fase in aperto (LAQ/5063 OL), dal termine della fase attiva in doppio cieco dello studio LAQ/5063 alla fase in aperto (LAQ/5063 OL) 8. Utilizzo dei substrati per l` enzima CYP1A2 quali teofillina e/o warfarin, nelle 2 settimane precedenti l`entrata nella fase in aperto (LAQ/5063 OL), dal termine della fase attiva in doppio cieco dello studio LAQ/5063 alla fase in aperto (LAQ/5063 OL) 9. Utilizzo di amiodarone dal termine della fase attiva in doppio cieco dello studio LAQ/5063 alla fase in aperto (LAQ/5063 OL) 10. In seguito al passaggio alla nuova formulazione (capsule), ipersensibilita` a mannitolo, meglumina o sodio stearil fumarato Criteri di esclusione per la fase in aperto dello studio (LAQ/5063 OL) - ulteriore estensione (dopo visita mese 24) a. Interruzione prematura dalla fase LAQ/5063 OL prima del completamento del periodo di trattamento di 24 mesi b. Gravidanza o allattamento
    E.5 End points
    E.5.1Primary end point(s)
    Long term safety
    Sicurezza a lungo termine
    E.5.2Secondary end point(s)
    Not applicable
    Non applicabile
    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 No
    E.6.6Pharmacokinetic No
    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.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 No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    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 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 years0
    E.8.9.1In the Member State concerned months60
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months60
    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.1.1Number of subjects for this age range: 0
    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.1.3Elderly (>=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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-03-01. Yes
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 167
    F.4.2.2In the whole clinical trial 246
    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 Decision2005-11-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-11-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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