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    Summary
    EudraCT Number:2005-004037-18
    Sponsor's Protocol Code Number:42603ATT3004
    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:2006-06-29
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2005-004037-18
    A.3Full title of the trial
    An Open Label, Multicenter Study to Evaluate the Long Term Safety of Prolonged Release (PR) OROS Methylphenidate (18, 36, 54, 72 and 90 mg/day) in Adults with Attention Deficit/Hyperactivity Disorder
    A.4.1Sponsor's protocol code number42603ATT3004
    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 SponsorJanssen-Cilag EMEA
    B.1.3.4CountryBelgium
    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 Yes
    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.3.4Pharmaceutical form Tablet
    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 INNMethylphenidate
    D.3.9.3Other descriptive nameMethylphenidate OROS®
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number18
    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.IMP: 2
    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.2.5The 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.3.4Pharmaceutical form Tablet
    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 INNMethylphenidate
    D.3.9.3Other descriptive nameMethylphenidate OROS®
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number36
    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.IMP: 3
    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.2.5The 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.3.4Pharmaceutical form Tablet
    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 INNMethylphenidate
    D.3.9.3Other descriptive nameMethylphenidate OROS®
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number54
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Attention Deficit/Hyperactivity Disorder
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.0
    E.1.2Level LLT
    E.1.2Classification code 10003733
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the open label study is to assess long term safety
    and tolerability of PR OROS methylphenidate in a flexible dose regimen
    (18-90 mg/day) in adult subjects diagnosed with ADHD.
    E.2.2Secondary objectives of the trial
    Secondary objectives are:
    · Assessment of the long term efficacy of PR OROS methylphenidate expressed
    as a function of change in the sum of the inattention and
    hyperactivity/impulsivity subscales of the investigator-rated CAARS.
    · Assessment of the long term effect on ADHD symptoms by means of change
    in total ADHD subscales.
    · Assessment of the long term effect on overall functioning, work, family and
    social functioning, and quality of life parameters as measured by the Clinical
    Global Impression Scale - Severity (CGI-S) and Change (CGI-C), Sheehan
    Disability Scale (SDS), Quality of Life Enjoyment and Satisfaction
    Questionnaire (Q-LES-Q) and Global Assessment of Effectiveness (GAE),
    respectively.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Subjects must satisfy the following criteria to be enrolled in the study:
    1. Subjects can be male or female.
    2. Age must be aged between 18 and 65 years, inclusive.
    3. Diagnosis of ADHD according to the Diagnostic and Statistical Manual
    of Mental Diseases, Fourth Edition (DSM-IV)1,32 and confirmed by the
    Conners’ Adult ADHD Diagnostic Interview for DSM-IV.
    4. Described chronic course of ADHD symptomatology from childhood to
    adulthood, with some symptoms present before age 7 years and continue
    to meet DSM-IV criteria at the time of assessment. ADHD is not
    diagnosed if the symptoms are better accounted for by another
    psychiatric disorder (e.g. mood disorder (especially bipolar disorder),
    anxiety disorder, psychotic disorder, personality disorder).
    5. Completion of the open label phase in the 42603ATT3002 trial
    according to protocol.
    6. Female subjects of child-bearing potential must agree to use an
    acceptable form of contraception (e.g., prescription oral contraceptives,
    contraceptive injections, intrauterine device, double-barrier method,
    contraceptive patch, male partner sterilisation) before entry and throughout the study, and must have a negative urine pregnancy test at
    screening.
    7. Informed Consent Form signed by the subject.
    8. Subject agrees to take only the supplied study drug as treatment for
    ADHD during the study.
    9. Subject agrees not to initiate a new behavioural modification
    programme during the study or if currently using a behavioural
    modification programme and agrees not to change this programme
    during the study.
    10. Subject is able to comply with the study visit schedule and willing and
    able to complete the protocol-specified assessments.
    11. Healthy on the basis of a physical examination, medical history and
    anamnesis.
    E.4Principal exclusion criteria
    Potential subjects who meet any of the following criteria will be excluded
    from participating in the study:
    1. Known to be a non-responder to methylphenidate, or subject has a child
    known to be a non-responder to methylphenidate.
    2. Known allergy or hypersensitivity to methylphenidate, or components of
    PR OROS methylphenidate.
    3. Has been treated with any methylphenidate-containing medication
    within 1 month of screening visit, except trial medication provided in
    42603ATT3002 trial
    4. Any clinically unstable psychiatric condition including but not limited to
    the following: acute mood disorder, bipolar disorder, acute obsessivecompulsive
    disorder (OCD), anti-social personality disorder, borderline
    personality disorder.
    5. Subjects with a family history of schizophrenia or family history of
    affective psychosis.
    6. Autism or Asperger’s syndrome.
    7. Subjects with presence of motor tics, history of Tourette’s syndrome or
    family history of Tourette’s syndrome.
    8. A diagnosis of substance use disorder (abuse/dependence) according to
    DSM-IV criteria within 6 months prior to screening evaluation (nicotine
    and caffeine dependence are not exclusionary). Episodic abuse in the
    past is not an exclusion criterion.
    9. Current eating disorder (e.g. bulimia, anorexia nervosa) or history of an
    eating disorder.
    10. Known or suspected mental retardation.
    11. Hyperthyroidism, myocardial infarction or stroke in the 6 months prior
    to screening for this study.
    12. Subjects with history of seizures, glaucoma or uncontrolled
    hypertension.
    13. Subjects with angina pectoris or cardiac arrhythmias
    14. Pregnant or breast-feeding females.
    15. Any co-existing medical condition or taking any concomitant
    medication that is likely to interfere with safe administration of
    methylphenidate including any herbal or homeopathic remedies; herbal
    and over-the-counter weight loss or diet preparations or drugs that
    contain stimulants.
    16. Use of monoamine oxidase inhibitors.
    17. Use of other anti-depressants (unless subject has been on a stable
    dosage during the 42603ATT3002 trial, in which case treatment may
    continue so long as dosage remains unchanged for the duration of the
    study) or mood stabilisers (e.g. anti-epileptics, lithium. Any medication
    likely to interfere with safe administration of methylphenidate.
    18. Use of clonidine or other alpha-2 adrenergic receptor agonists,
    antipsychotic medications, theophylline, coumarin anticoagulants,
    anticonvulsants.
    19. Subjects who have clinically significant gastrointestinal problems,
    including severe narrowing (pathologic or iatrogenic) of the
    gastrointestinal tract.
    20. Subjects who are unable to swallow the study medication whole with the
    aid of liquids (participants may not chew, divide, dissolve or crush the
    study medication).
    21. History of severe drug allergy or hypersensitivity.
    22. Any serious illnesses including, but not limited to liver or renal
    insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal,
    endocrine, neurological, psychiatric or metabolic disturbances.
    23. Confirmed cancer or malignancy.
    24. Employee of the investigator or the institution who have direct
    involvement in the trial or other trials under the direction of the
    investigator or their members.
    E.5 End points
    E.5.1Primary end point(s)
    EFFICACY CRITERIA:
    The primary efficacy criterion will be the change in the sum of the inattention and
    hyperactivity/impulsivity subscale scores of the investigator-rated CAARS from baseline at the end of
    the open follow-up phase.
    Secondary end points will include changes from baseline to the end of the treatment in:
    · CGI
    · Conners’ Adult ADHD Self-Report Short Version (CAARS-S:S)
    · SDS
    · Q-LES-Q
    · GAE
    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 No
    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 No
    E.8.1.2Open Yes
    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) No
    E.8.2.2Placebo No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Please refer to page 37 item 16.8 of the protocol.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months14
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months14
    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.1.3Elderly (>=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 Information not present in EudraCT
    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 2006-06-29. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 400
    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)
    Please refer to protocol provided.
    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 Decision2006-03-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-02-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-07-10
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