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    Summary
    EudraCT Number:2016-004710-95
    Sponsor's Protocol Code Number:REPAS161118
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-01-10
    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 ConcernedSweden - MPA
    A.2EudraCT number2016-004710-95
    A.3Full title of the trial
    Extended-release injectable suspension naltrexone (XR-NTX) as an adjunt pharmacotherapy for prevention of substance use in patients with SUD who are currently in treatment for ADHD: A multicenter randomized placebo-controlled trial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Extended-release injectable suspension naltrexone (XR-NTX) as an adjunct pharmacotherapy for prevention of drug use in patients with substance use disorder in treatment for ADHD
    A.3.2Name or abbreviated title of the trial where available
    REPAS (Relapse prevention in ADHD/SUD)
    A.4.1Sponsor's protocol code numberREPAS161118
    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 SponsorBeroendecentrum Stockholm
    B.1.3.4CountrySweden
    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 supportBeroendecentrum Stockholm
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportAlkermes
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportSwedish research council
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportSwedish research council for health, working life and welfare
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBeroendecentrum Stockholm
    B.5.2Functional name of contact pointMagnus Huss clinic
    B.5.3 Address:
    B.5.3.1Street AddressGävlegatan 22C, level 6
    B.5.3.2Town/ citystockholm
    B.5.3.3Post code11330
    B.5.3.4CountrySweden
    B.5.6E-mailnasim.caspillo@sll.se
    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 vivitrol
    D.2.1.1.2Name of the Marketing Authorisation holderFDA
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameNaltrexone
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNALTREXONE
    D.3.9.1CAS number 16590-41-3
    D.3.9.4EV Substance CodeSUB09143MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1140
    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 placeboInjection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Amphetamine dependence and ADHD (Attention-Deficit/Hyperactivity
    Disorder)
    E.1.1.1Medical condition in easily understood language
    Patients who fulfil DSMIV/5 criteria for amphetamine dependence and
    ADHD (Attention-Deficit/Hyperactivity Disorder), respectively
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    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
    Evaluation of naltrexone as relapse prevention for substance use in
    patients with ADHD who are currently using central stimulant
    medication.
    E.2.2Secondary objectives of the trial
    Proportion of urine samples free of drugs of abuse (with the exclusion of
    THC), (ITT and completers analysis) without imputing missing data
    Proportion of urine samples free of THC (qualitative measure; below the
    laboratory's standard cutoff) in all randomized participants who took at
    least 1 study medication dose (ITT)
    Time to first relapse (first positive urine toxicology; any of tested drugs)
    Self-reported days of drug and alcohol use as measured by TLFB
    Proportion of urine samples positive of benzodiazepines
    Craving as measured by VAS scale
    Depression rating as measured by MADRS-S Scale
    Levels of NTX and its metabolite in plasma and correlation with
    measures of drug use, craving and side effects over the course of
    treatment
    Levels of ASAT and ALAT
    Levels of PEth
    Cognitive function as measured by CANTAB between 2 treatment arms
    Change in observer-rated ADHD-symptoms as measured with Conners'
    Adult ADHD Scale
    Observer version (CAARS-O: SV)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Adult male or female aged 18-70 years
    2) Written, informed consent to participate
    3) Fulfil DSM-5 criteria for ADHD
    4) Ongoing central stimulant pharmacotherapy (e.g. methylphenidate,
    amphetamines) for ADHD,
    irrespective of duration or dose, formulation or brand.
    5) Fulfil DSM-5 criteria for alcohol use disorder, and/or stimulant use
    disorder, and/or opioid use
    disorder, having a minimum of 2 relapses (=drug use on two separate
    days, and/or two heavy drinking
    days) in the last 30 days as defined by self-report and/or by urine
    toxicology
    6) One negative urine sample (amphetamine, cocaine, opiates, THC and
    benzodiazepines) and
    negative alcohol breathalyser test within four days prior to the day of
    inclusion
    7) One negative urine sample for opiates (dip stick test) immediately
    prior to administering the first
    dose of study medication
    8) Address and telephone in the metropolitan area of each participating
    centre, respectively, where the
    participant can be reached
    E.4Principal exclusion criteria
    1) Current DSM-5 diagnosis of severe opioid substance use disorder,
    2) Manifestation of withdrawal symptoms or reports of current withdrawal symptoms of opioids
    3) Current psychiatric condition considered by the study physician to be severe and/or unstable (e.g., psychosis, schizophrenia, bipolar, suicidal or homicidal)
    4) Known or suspected use of any opioid medication or illicit opiates in the last 7 days prior to inclusion
    5) Ongoing benzodiazepine pharmacotherapy (medically motivated doses for e g withdrawal treatment during the trial do not constitute a reason for exclusion)
    6) Somatic disorder (e.g., cancer, seizure disorder, severe hypertension and liver cirrhosis) determined to be serious in the clinical judgement of the study physician
    7) Acute hepatitis or liver damage as evidenced by serum aspartate (AST) or alanine aminotransferase (ALT) concentration greater than three times the upper normal reference range, or serum bilirubin greater than 10% above the upper normal limit.
    8) Female subjects who are pregnant or lactating or of child bearing potential who are not using acceptable methods of birth control. Specified as combined hormonal contraception associated with inhibition of ovulation (orally, intravaginal or transdermal), progesterone-only hormonal contraception associated with inhibition of ovulation (oral, injectable,
    implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner, condom or sexual abstinence.
    9) Known hypersensitivity to naltrexone, polylactide-co-glycolide (PLG), carboxymethylcellulose or any other compounds of the diluent
    10) Likely to receive opioid analgesics in the next 6-months associated with possible or scheduled surgery or procedure
    11) Use of an investigational agent in the last 30 days
    11) Subjects with a body abnormality precluding the use of the customized needle for intramuscularinjection, based on clinical judgement
    E.5 End points
    E.5.1Primary end point(s)
    a) Proportion of urine samples free of drugs, where missing urine data is
    considered as a positive
    sample (with the exclusion of THC), with intention-to-treat analysis and
    completers analysis,
    respectively.
    b) Percent of heavy drinking days defined as five or more drinks for men,
    four or more for women
    assessed by TLFB.
    c) Change in self-rated ADHD symptoms as measured by the Adult ADHD
    self-report scale (ASRS v.
    1.1) in all participants who took at least the 1st study medication dose.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    E.5.2Secondary end point(s)
    Proportion of urine samples free of drugs of abuse (with the exclusion of
    THC), in all randomized
    participants who took at least 1 study medication dose (ITT and
    completers analysis) without imputing
    missing data for positives
    Proportion of urine samples free of THC (qualitative measure; below the
    laboratory's standard cutoff)
    in all randomized participants who took at least 1 study medication dose
    (ITT)
    Time to first relapse (first positive urine toxicology; any of tested drugs)
    Self-reported days of drug and alcohol use as measured by TLFB
    Proportion of urine samples positive of benzodiazepines
    Craving as measured by VAS scale
    Depression rating as measured by MADRS-S Scale
    Levels of NTX and its metabolite in plasma and correlation with
    measures of drug use, craving and
    side effects over the course of treatment
    Levels of ASAT and ALAT to evaluate medication safety and tolerability-
    Levels of PEth to monitor heavy alcohol use Cognitive function as measured by CANTAB between 2 treatment arms
    Change in observer-rated ADHD-symptoms as measured with Conners'
    Adult ADHD Scale Observer version (CAARS-O: SV)
    Drug and alcohol use as measured by TLFB at the follow-up period, post
    12 weeks treatment.
    E.5.2.1Timepoint(s) of evaluation of this end point
    LPLV
    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 Yes
    E.6.7Pharmacodynamic Yes
    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 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.8.2.4Number of treatment arms in the trial2
    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 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 years3
    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: 128
    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 No
    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 2017-01-10. 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 state128
    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
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-02-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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