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    Summary
    EudraCT Number:2010-021474-11
    Sponsor's Protocol Code Number:GE-001-013
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-09-20
    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 ConcernedGermany - BfArM
    A.2EudraCT number2010-021474-11
    A.3Full title of the trial
    A Multicentre, Randomised, Open-label, Comparative Phase IV Trial To Assess Changes in Dementia Diagnostic Category and Diagnostic Confidence After DaTSCAN Imaging in Subjects with an Uncertain Diagnosis of Dementia with Lewy Bodies (DLB)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to assess changes in diagnosis of dementia after DaTSCAN
    imaging in patients with suspected diagnosis of Dementia with Lewy
    Bodies
    A.4.1Sponsor's protocol code numberGE-001-013
    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 SponsorGE Healthcare Ltd. and its Affiliates
    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 supportGE Healthcare Ltd.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGE Healthcare Ltd.
    B.5.2Functional name of contact pointClinical Project Leader
    B.5.3 Address:
    B.5.3.1Street AddressCalle Gobelas 35 - 37 Urb. La Florida
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28023
    B.5.3.4CountrySpain
    B.5.4Telephone number34916630970
    B.5.6E-mailEmilio.Moreno@ge.com
    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 DaTSCAN
    D.2.1.1.2Name of the Marketing Authorisation holderGE Healthcare Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameDaTSCAN
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN[123I] ioflupane
    D.3.9.1CAS number 155798-07-5
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive name[123I]FP-CIT
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number74 to at reference time
    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 Yes
    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
    Subjects with possible Dementia with Lewy Bodies (DLB) who may or may not also fulfil the criteria for Alzheimers Disease (AD)
    E.1.1.1Medical condition in easily understood language
    Patients with diagnosis of dementia and suggestion of Dementia with
    Lewy Bodies (DLB)
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    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
    To evaluate the impact of DaTSCAN imaging on dementia diagnostic category and confidence in diagnosis in subjects with an uncertain diagnosis of Dementia with Lewy Bodies (possible DLB)
    E.2.2Secondary objectives of the trial
    To demonstrate that the use of DaTSCAN improves confidence in diagnosis in these subjects.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (1) Male or female 55 years of age or older.

    (2) Mini-Mental State Examination (MMSE) between 10 and 28.

    (3) Subjects with Possible DLB as defined by the International Consensus Criteria (dementia +1 core feature or 1 or more suggestive features), who may or may not also fulfil criteria for AD.

    (4) The subject and a legally acceptable representative (e.g., the subject’s carer) are able and willing to comply with study procedures and signed and dated informed consent is obtained from each.

    (5) The subject and a legally authorised representative are able to co-operate with the protocol and involvement would not adversely affect subject care, in the opinion of the investigator.

    (6) Women who are surgically sterile (have had documented oophorectomy and/or documented hysterectomy) or are postmenopausal (cessation of menses for more than 1 year) will be allowed to enrol in the study without a pregnancy test at screening.
    E.4Principal exclusion criteria
    (1) Having an established/certain clinical diagnosis of Probable DLB or non-DLB form of dementia.

    (2) Parkinsonism >1 year prior to onset of dementia.

    (3) Severe extrapyramidal symptoms (Unified Parkinson’s Disease Rating Scale, Part 3 [UPDRS-III] >30) or Parkinson’s disease dementia.

    (4) Known/suspected significant vascular pathology with multiple or strategic infarcts or vascular pathology in the striatum/basal ganglia as shown preferably by previous magnetic resonance imaging (MRI) or computed tomography (CT) examination. If MRI is not available prior to
    baseline and there is no contraindication, the subject will have to
    undergo an MRI scan during the course of the study to confirm that no
    significant vascular pathology is present. If an MRI is not clinically
    feasible, cerebral CT imaging within 6 months prior to baseline or during
    the study is also acceptable.

    (5) Symptoms suggestive of multiple system atrophy, corticobasal degeneration, progressive supranuclear palsy, or Huntington’s disease.

    (6) Persistent severe mental illness including depression, schizophrenia and schizoaffective illness.

    (7) Normal pressure hydrocephalus.

    (8) Use of any concomitant medication that is known or suspected to interact with striatal uptake through direct competition with binding of DaTSCAN to the DaT that could not be discontinued for at least 5 half-lives if the subject were to be randomized to the DaTSCAN group (these include amphetamine, benztropine, bupropion, cocaine, mazindol, methylphenidate, phentermine and sertraline).

    (9) Presence of moderate to severe renal or hepatic impairment.

    (10) Occupational exposure to radiation equal to or above 15 mSv per year.

    (11) History of abuse or current abuse of drugs.

    (12) History of alcohol abuse where period of abstinence is less than 3 years.

    (13) Hypersensitivity to DaTSCAN or any of its ingredients.

    (14) Previous inclusion in this study.

    (15) Female subjects who are pregnant or breast-feeding or planning a pregnancy during the course of this study or within 3 cycles of completing the study. Women of childbearing potential, have to provide a negative beta human chorionic gonadotropin (b-HCG) pregnancy test (by urine dipstick method) at screening and also prior to IMP administration.

    (16) Participation in a clinical study involving an unlicensed pharmaceutical product within 30 days prior to screening, and/or an unlicensed/licensed radiopharmaceutical within 5 radioactive half-lives prior to screening.

    (17) The subject has a life threatening disease state with a life expectancy of less than 1 year or history of significant medical disease, trauma, or surgical intervention that in the judgement of the investigators makes the subject unsuitable for the study.

    (18) The subject has already had DaTSCAN SPECT imaging or any other similar functional imaging test of the pre-synaptic and/or post-synaptic dopaminergic system (e.g., [18F]DOPA PET, [123I]iodobenzamide).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the proportion of subjects in each group who have had a change in a diagnostic category between the baseline visit (V1) and the 8-week visit (V2).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline visit V1
    8 week visit V2
    E.5.2Secondary end point(s)
    • Confidence in clinical diagnosis. This will be assessed at baseline (V1),
    8 weeks (V2), and 24 weeks (V3) visits, using a visual analogue scale
    ranging 0 to 100% with predefined qualitative levels of confidence.

    • Changes in clinical diagnostic category between the baseline (V1) and
    24 week (V3) visits.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Clinical diagnosis confidence evaluated at:
    Baseline V1
    8 weeks V2
    24 weeks V3

    Changes in clinical diagnostic category evaluated at:
    Baseline V1
    24 weeks V3
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    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 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 Yes
    E.7.1.3.1Other trial type description
    Phase IV diagnostic trial
    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 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 Yes
    E.8.2.3.1Comparator description
    parallel group without DaTSCAN imaging
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Last subject last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 74
    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 Yes
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 174
    F.4.2.2In the whole clinical trial 174
    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)
    No treatment or care planned after the trial. Expected normal
    treatment of the condition.
    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 Decision2010-11-10
    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 StatusCompleted
    P.Date of the global end of the trial2012-10-08
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