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    Summary
    EudraCT Number:2012-003136-23
    Sponsor's Protocol Code Number:CRO1990
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-11-16
    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 ConcernedUK - MHRA
    A.2EudraCT number2012-003136-23
    A.3Full title of the trial
    Lamotrigine And Borderline Personality Disorder: Investigating Long-Term Effectiveness
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Lamotrigine And Borderline Personality Disorder: Investigating Long-Term Effectiveness
    A.3.2Name or abbreviated title of the trial where available
    LABILE
    A.4.1Sponsor's protocol code numberCRO1990
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN90916365
    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 SponsorImperial College London
    B.1.3.4CountryUnited Kingdom
    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 supportNIHR Health Technology Assessment
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationImperial College London
    B.5.2Functional name of contact pointLABILE Trial Coordinating Office
    B.5.3 Address:
    B.5.3.1Street AddressClaybrook Centre, 37 Claybrook Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW6 8LN
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02073861220
    B.5.5Fax number02073861216
    B.5.6E-maillabile@imperial.ac.uk
    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 Lamotrigine - generic product
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameLamotrigine
    D.3.2Product code n/a
    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.3.8INN - Proposed INNLamotrigine
    D.3.9.1CAS number 84057-84-1
    D.3.9.3Other descriptive name6-(2,3-dichlorophenyl)-1,2,4-triazine-3,5-diamine
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25mg to 200mg
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    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
    Borderline Personality Disorder
    E.1.1.1Medical condition in easily understood language
    People with borderline personality disorder experience high levels of emotional distress and often experience other problems including negative feelings about themselves and rapid changes in mood.
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10042033
    E.1.2Term Stevens-Johnson syndrome
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10019211
    E.1.2Term Headache
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10028821
    E.1.2Term Nausea with vomiting
    E.1.2System Organ Class 100000004856
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10040913
    E.1.2Term Skin rash
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10024264
    E.1.2Term Lethargy
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10013649
    E.1.2Term Drowsiness
    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
    The principal aim is to investigate the clinical and cost-effectiveness of adding lamotrigine to usual care for adults with Borderline Personality Disorder. To achieve this, we will: - Test whether adding lamotrigine to usual care for adults with Borderline Personality Disorder improves mental health over a 52 week period, in comparison to a placebo control. - Examine whether the addition of lamotrigine to usual care for adults with Borderline Personality Disorder improves social functioning and quality of life, reduces the incidence of suicidal behaviour, and lowers the amount of antipsychotic and other psychotropic medication that people are prescribed, in comparison to a placebo control. - Compare the incidence of side effects among those prescribed lamotrigine in addition to usual care for adults with Borderline Personality Disorder, in comparison to a placebo control. - Examine the cost, cost-utility and cost-effectiveness of adding lamotrigine to usual care for a
    E.2.2Secondary objectives of the trial
    n/a
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria: - Age 18 and over. - Fulfilling DSM-IV diagnostic criteria for Borderline Personality Disorder. - Competent and willing to provide written, informed consent.
    E.4Principal exclusion criteria
    Exclusion Criteria: - Currently fulfilling criteria for Bipolar affective disorder (type I & II), or psychotic disorder (schizophrenia, schizoaffective disorder, or mood disorder with psychotic features). - At present receiving a mood stabiliser(s) (e.g lithium, carbamazepine, or valproate)*. - Known medical history of liver or kidney impairment. - Cognitive or language difficulties that would preclude subjects providing informed consent or compromise participation in study procedures. - Any woman who is pregnant or planning a pregnancy, and any woman of child bearing potential unless using adequate contraception. This will be established using structured questioning at screening and follow-up, and documented in the case report form. - Participation in any other clinical trial within the past 4 months. *Participants will be required to discontinue any mood stabiser(s) (e.g. lithium, carbamazepine, or valproate) for at least four weeks before entry into the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure is symptoms of Borderline Personality Disorder measured at 52 weeks using the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD). The ZAN-BPD is a widely used measure of symptoms and behavioural problems experienced by people with BPD. It includes measures of anger, impulsivity and affective instability. The ZAN-BPD has been used in previous studies of pharmacological and psychological treatments for people with BPD and is sensitive to change.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Stated above.
    E.5.2Secondary end point(s)
    - Total score on the ZAN-BPD at baseline, 12 and 24 weeks; - Depression: depressive symptoms will be assessed using the 21-item Beck Depression Inventory at baseline, 12, 24 and 52 weeks. The Beck Depression Inventory has been widely used as a self-complete questionnaire, providing a valid assessment of the severity of depressive symptoms and can be completed in less than 10 minutes. - Self-harm: incidence and severity of suicidal behaviour will be assessed using the Acts of Deliberate Self-Harm Inventory at baseline, 12, 24 and 52 weeks. This structured interview collects detailed information about the number and severity of episodes of self-harm and has been used successfully in other trials of treatments for people with BPD31. - Social functioning: social functioning will be assessed using the Social Functioning Questionnaire at baseline, 12, 24 and 52 weeks. The questionnaire is an eight-item self-report scale that asks people about problems across a range of settings that people with personality disorder often experience. - Health-related quality of life: health related quality of life will be assessed using the Euro-QOL-5D (EQ-5D) at baseline, 12, 24 and 52 weeks. The EQ-5D provides a brief and reliable measure of health-related quality of life which is responsive to change in people with BPD. - Side effect scale: possible side effects of lamotrigine will be assessed using a proforma designed to cover the possible effects listed in the British National Formulary (BNF) entry for lamotrigine, at baseline, 12, 24, and 52 weeks. - Service use: resource use will be collected using a modified version of the Adult Service Use Schedule at baseline, 12, 24 and 52 weeks. This questionnaire collects detailed data on use of all hospital and community health and social care services including medication. - Medication adherence: to assess medication adherence at 12, 24 and 52 weeks the Morisky Scale shall be utilized.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Stated above.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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.8.3 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 concerned5
    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 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
    The trial will finish once the last/final participant ceases to take the study medication, whether this is due to them reaching the end of the participation period (54 weeks), withdrawal or other reason.
    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 months6
    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 months6
    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.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    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 state252
    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)
    Prescribing clinician can decide to maintain lamotrigine treatment after the end of the trial if they have percieved a favourable risk-benefit balance and consider that continued treatment is clinically indicated. 52 weeks after a participant is randomised into the study, regardless of whether the participant withdraws from the study early or completes the participation period in full, a letter will be sent to the referring psychiatrist informing them of the participant’s trial arm allocation
    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 Mental Health Research Network
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-11-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-09-22
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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