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    Summary
    EudraCT Number:2012-000801-64
    Sponsor's Protocol Code Number:BTG001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-11-26
    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 number2012-000801-64
    A.3Full title of the trial
    A Phase IV Acceptability and Feasibility Trial of the Effects of Medication on Memory in Idiopathic Nondementing Parkinson’s Disease.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of the effects of medication on memory in Parkinson's Disease
    A.3.2Name or abbreviated title of the trial where available
    Medication and Memory in Parkinson’s Disease (MeMory PaD)
    A.4.1Sponsor's protocol code numberBTG001
    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 SponsorUniversity Hospital of North Staffordshire
    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 supportNational Institute for Health Research
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKeele University
    B.5.2Functional name of contact pointProf Nicola Edelstyn
    B.5.3 Address:
    B.5.3.1Street AddressSchool of Psychology, Keele University,
    B.5.3.2Town/ cityKeele
    B.5.3.3Post codeST5 5BG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01782734318
    B.5.5Fax number01782733387
    B.5.6E-mailn.edelstyn@keele.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorKeele University
    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 supportNational Institute for Health Research
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKeele University
    B.5.2Functional name of contact pointProf Nicky Edelstyn
    B.5.3 Address:
    B.5.3.1Street AddressSchool of Psychology,
    B.5.3.2Town/ cityKeele, Staffordshire
    B.5.3.3Post codeST5 5BG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01782734318
    B.5.5Fax number01782733387
    B.5.6E-mailn.edelstyn@keele.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 Mirapexin extended release various strengths
    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 namePramipexole dihydrochloride monohydrate extended release
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Modified-release tablet
    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 INNpramipexole dihydrochloride monohydrate
    D.3.9.1CAS number 104632-26-0
    D.3.9.2Current sponsor codenot available
    D.3.9.3Other descriptive nameMirapexin
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number3.15
    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.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.2.1.1.1Trade name Requip prolonged release
    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 nameRopinirole hydrochloride prolonged release
    D.3.4Pharmaceutical form Modified-release tablet
    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 INNRopinirole (as hydrochloride)
    D.3.9.1CAS number 91374-21-9
    D.3.9.2Current sponsor codenot available
    D.3.9.3Other descriptive nameRequip XL prolonged-release
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number24
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Idiopathic Parkinson's Disease
    E.1.1.1Medical condition in easily understood language
    Parkinson's Disease in the absence of other family history of the condition.
    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 17.0
    E.1.2Level LLT
    E.1.2Classification code 10013113
    E.1.2Term Disease Parkinson's
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This is a feasibility study designed to inform the following process / primary outcomes:
    • to obtain estimates of memory performance which will inform a power calculation;
    • to explore with patient-participants and carers barriers to participation which include management of symptoms during washout period. This will be achieved formally using the end of study focus group as well as informally during mid-and end of study clinic visits with clinical members of research team, and during ON/OFF research visits with the PhD student/assessor.

    E.2.2Secondary objectives of the trial
    • drop-out rate;
    • effectiveness of recruitment strategy;
    • identification of training needs of members of the research team and patient-participant participant panel (PPI);
    • to obtain estimates of memory performance which will inform a power calculation gathered during ON and OFF research sessions;
    • establish the likely staffing resources and timetable needed for the subsequent main study;
    • validate composition of the neuropsychological test battery;
    • to gather personal reflections of patient-participant participants and public and patient-participant involvement (PPI) members on their respective research experience.
    • to explore with patient-participants and carers barriers to participation which include
    o relative timing of ON and OFF sessions in each treatment arm
    o duration of the ON and OFF research sessions.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Demographic characteristics

    • Males and females.
    • Aged between 50-80 years.

    Medical condition

    • Idiopathic, sporadic Parkinson’s disease, diagnosed by as determined by the UK Parkinson’s Disease Society Brain Bank Clinical Diagnostic Criteria (1992).
    • Parkinson’s disease stages, mild: 1, 2, 2.5; or moderate: 3 and 4, as determined by the modified Hoehn-Yahr (HY) disease severity rating scale.
    • Capacity to provide fully informed signed consent.

    Indicated treatments:

    • Currently medicated with either Pramipexole modified release (Mirapexin® Prolonged Release) 520 micrograms to 3.15mg or Ropinirole modified release (Requip® XL) range 2mg to 12mg.
    • Maybe receiving adjuvant therapy with l-dopa and / or a monoamine oxidase B inhibitor (such as rasagiline/AZILECT or selegiline/ ELDEPRYL, ZELAPAR).

    *Note Patients who are not receiving adjuvant therapy will also meet the inclusion criteria.
    E.4Principal exclusion criteria
    All doses of IMP that fall outside of the inclusion criteria

    Demographic Characteristics:
    - Patient-participant-participants younger than 50 and over 80 years of age;
    - English is a second language.

    Medical, Psychiatric, Developmental Conditions:
    Renal impairment (creatinine clearance <50ml/min or eGFR less than 50 ml/minute/1.73m2)Severe hepatic impairment (liver function tests: ALT, Total Bilirubin, Albumin Alk phos/ALP; GGT may also be assessed– depending on the Alk level - 3 times upper limit of normal range)
    Women of child bearing potential unless they are using a recognised effective form of contraception or are not sexually active, and have no intention of becoming sexually active during the course of the trial;
    Cognitive impairment as assessed with the Mini-Mental State Examination scoring 25 or less;
    Severe PD, indicated by a score of 5 on the Hoehn and Yahr disease severity rating scale;
    - Unable to provide informed consent due to cognitive decline;
    - Co-morbid for another neurological illness (other than PD);
    - History of learning difficulty including dyslexia;
    - Physical inability to attend or comply with treatment scheduling, such as upper limb amputations, crippling degenerative arthritis;
    - Current or planned participation in another drug trial;
    - Active malignancy;
    - Family history of PD;
    -Patient or family history of allergic reaction to either ropinirole or pramipexole
    - Drug abuse or alcoholism;
    - Major psychotic phenomenology including hallucinations or lack of awareness of dyskinesias;
    - Hypotension;
    - Severe dizziness or fainting on standing;
    - Impulse control disorders or compulsive behaviours;
    - Incapacitating dyskinesias on a stable dose of l-dopa;
    - pre-planned or elective surgeries during the period of involvement in the trial.

    Contraindicated Medication and Treatments:
    COMT inhibitors; apomorphine; amantadine; anticholinergics; dopamine antagonists; ciprofloxacin; immediate-release preparations of either pramipexole dihydrochloride monohydrate or ropinirole hydrochloride; deep brain stimulation.
    E.5 End points
    E.5.1Primary end point(s)
    This is a feasibility study designed to inform the following process outcomes:

    - to obtain estimates of memory performance which will inform a power calculation;

    - management of symptoms during washout period
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of study.
    E.5.2Secondary end point(s)
    None.
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    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 No
    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 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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 16
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 34
    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 state55
    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)
    At the end of study visit with the clinical team, once participation in the study has ceased, the PI will make a decision about each patient's on-going medication regimen. This decision will be informed by the patient's subjective experience of being on each drug, the patient's pre-study clinical history, and clinical efficacy and tolerability of ropinirole hydrochloride prolonged release and pramipexole dihydrochloride monohydrate extended release.
    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 West Midlands (North) CLRN
    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 Decision2012-11-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-03-04
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