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    Clinical Trial Results:
    A Phase IV Acceptability and Feasibility Trial of the Effects of Medication on Memory in Idiopathic Parkinson’s Disease without Cognitive Impairment

    Summary
    EudraCT number
    2012-000801-64
    Trial protocol
    GB  
    Global end of trial date
    04 Mar 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    20 Mar 2016
    First version publication date
    20 Mar 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BTG001
    Additional study identifiers
    ISRCTN number
    ISRCTN39374171
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    University Hospitals of North Midlands NHS Trust
    Sponsor organisation address
    Newcastle Road, Stoke-on-Trent, United Kingdom, ST4 6QG
    Public contact
    Dr Darren Clement, University Hospitals of North Midlands NHS Trust, 01782 675379, Darren.clement@uhns.nhs.uk
    Scientific contact
    Dr Darren Clement, University Hospitals of North Midlands NHS Trust, 01782 675379, Darren.clement@uhns.nhs.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    02 Jun 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Jan 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Mar 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    This is a feasibility and acceptability trial designed to inform the following process / primary outcomes: • to obtain estimates of memory performance which will inform a power calculation; data collected during ON and OFF research sessions • to examine the efficacy of processes and procedures used to manage symptoms during the washout periods (assessed at the mid and end of study clinic visits, and the semi-structured interview administered at the end of the trial). In addition there were several secondary outcomes including assessing the drop out rate, effectiveness of the recruitment strategy, identifying training needs of the team, establishing the likely staffing resources for a fully powered trial, validate the composition of the neuropsychological test battery, gather personal reflections of participants on their research experience and explore barriers to participation.
    Protection of trial subjects
    Participants were required to have a recent blood sample to ensure the kidney and liver function was not impaired (Exclusion criteria included renal impairment and severe liver impairment). Participants were given a 24 hour contact number should the participant encounter any problems during the study.
    Background therapy
    Participants may (or may not) be receiving adjuvant therapy with L-dopa and / or a monoamine oxidase B inhibitor (such as rasagiline / AZILECT or selegiline/ ELDEPRYL, ZELAPAR).
    Evidence for comparator
    -
    Actual start date of recruitment
    23 Apr 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 22
    Worldwide total number of subjects
    22
    EEA total number of subjects
    22
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    12
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    This was a single centre trial (based at University Hospital of North Midlands NHS Trust). Local GP practices and community pharmacists acted as Participant Identification Centres, passing on study details to potential participants.

    Pre-assignment
    Screening details
    Screening visit assessments/questionnaires: Functional assessment of mental capacity by CI/PI, Informed consent, Mini-Mental State examination , Review inclusion/exclusion criteria, Physical exam, Vital signs (BP, pulse, respiration rate, temperature, weight, height), blood test, PD symptom assessment, Hospital depression and anxiety scale, mood.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Single blind
    Roles blinded
    Assessor [1]
    Blinding implementation details
    The PhD student /assessor was blind to the participants' medications during the trial and for the analysis period.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    ARM 1:Pramipexole followed by Ropinirole
    Arm description
    The order of IMPs in treatment arm 1 is pramipexole prolonged release followed by ropinirole prolonged release.
    Arm type
    Change to the order of drugs

    Investigational medicinal product name
    Pramipexole prolonged release
    Investigational medicinal product code
    ATC N04BC05
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Pramipexole prolonged release max. 3.15 mg once daily, min. 0.52mg once daily.

    Investigational medicinal product name
    Ropinirole prolonged release
    Investigational medicinal product code
    ATC N04BC04
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ropinirole prolonged release max. 12 mg once daily, min 2mg once daily

    Arm title
    ARM 2: Ropinirole followed by Pramipexole
    Arm description
    The order of IMPs in treatment arm 2 is ropinirole prolonged release followed by pramipexole prolonged release.
    Arm type
    Order of IMPs is reversed

    Investigational medicinal product name
    Ropinirole prolonged release
    Investigational medicinal product code
    ATC N04BC04
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ropinirole prolonged release max. 12 mg once daily, min 2mg once daily

    Investigational medicinal product name
    Pramipexole prolonged release
    Investigational medicinal product code
    ATC N04BC05
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Pramipexole prolonged release max. 3.15 mg once daily, min. 0.52mg once daily

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: Only the PhD student/assessor (who performed memory recollection assessments with the participant) was blinded to the participants trial drug.
    Number of subjects in period 1
    ARM 1:Pramipexole followed by Ropinirole ARM 2: Ropinirole followed by Pramipexole
    Started
    10
    12
    Completed
    7
    9
    Not completed
    3
    3
         Adverse event, non-fatal
             3
             3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    Twenty two participants represents the number of participants randomised into the trial and received trial drugs. A total of 28 participants consented into the study, however these were determined to be ineligible at the screening visit, and therefore did not participate in the trial or receive study drugs.

    Reporting group values
    Overall trial Total
    Number of subjects
    22 22
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Age characteristics for 22 participants randomised into the trial and received trial drugs.
    Units: years
        arithmetic mean (standard deviation)
    65.7 ± 8.1 -
    Gender categorical
    Gender characteristics for 22 participants randomised into the trial and received trial drugs.
    Units: Subjects
        Female
    6 6
        Male
    16 16

    End points

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    End points reporting groups
    Reporting group title
    ARM 1:Pramipexole followed by Ropinirole
    Reporting group description
    The order of IMPs in treatment arm 1 is pramipexole prolonged release followed by ropinirole prolonged release.

    Reporting group title
    ARM 2: Ropinirole followed by Pramipexole
    Reporting group description
    The order of IMPs in treatment arm 2 is ropinirole prolonged release followed by pramipexole prolonged release.

    Primary: Provide estimates of memory performance which will inform a power calculation for a large randomised controlled trial (memory recollection data collected during ON- and OFF-medication research sessions)

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    End point title
    Provide estimates of memory performance which will inform a power calculation for a large randomised controlled trial (memory recollection data collected during ON- and OFF-medication research sessions)
    End point description
    For the ON research session, medication was taken as usual roughly 60 minutes before the session. For the OFF session, medication was delayed prior to the memory recollection. Medication was resumed following completion of the memory recollection, according to criteria discussed with the CI/PI.
    End point type
    Primary
    End point timeframe
    As per protocol, assessments (memory recollection) performed after a six week stabilisation period on IMP. Assessments were conducted both ON and OFF drug (the medication was withheld during the OFF session according to the half lives of the drug).
    End point values
    ARM 1:Pramipexole followed by Ropinirole ARM 2: Ropinirole followed by Pramipexole
    Number of subjects analysed
    7 [1]
    9 [2]
    Units: Memory recall
    7
    9
    Notes
    [1] - All patients received both IMPs (order of IMPS randomised between 2 arms). 7 had pramipexole first.
    [2] - All patients received both IMPs (order of IMPS randomised between 2 arms). 9 had ropinirole first.
    Statistical analysis title
    Confidence interval ropinirole
    Statistical analysis description
    Acceptability and feasibility trial: The confidence interval around the mean difference in memory recollection between ON and OFF each IMP (trial drug) was calculated. Data from both arms was combined for the analysis.
    Comparison groups
    ARM 1:Pramipexole followed by Ropinirole v ARM 2: Ropinirole followed by Pramipexole
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    other [3]
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    0.007
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.07
         upper limit
    0.084
    Variability estimate
    Standard deviation
    Notes
    [3] - As this was a acceptability and feasibility trial, we were not concerned with statistical significance with regards to memory recollection as the group sizes were not large enough to detect a difference if it existed. It is important to note that at this stage in the program of research there is still no firm evidence that dopaminergic medication in particular pramipexole affects memory. Therefore people with Parkinson’s should not change their medication based on this trial.
    Statistical analysis title
    Confidence interval pramipexole
    Statistical analysis description
    Acceptability and feasibility trial: The confidence interval around the mean difference in memory recollection between ON and OFF each IMP (trial drug) was calculated. Data from both arms was combined for the analysis.
    Comparison groups
    ARM 1:Pramipexole followed by Ropinirole v ARM 2: Ropinirole followed by Pramipexole
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    other [4]
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    0.03
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.019
         upper limit
    0.079
    Variability estimate
    Standard deviation
    Notes
    [4] - As this was a acceptability and feasibility trial, we were not concerned with statistical significance with regards to memory recollection as the group sizes were not large enough to detect a difference if it existed. It is important to note that at this stage in the program of research there is still no firm evidence that dopaminergic medication in particular pramipexole affects memory. Therefore people with Parkinson’s should not change their medication based on this trial.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected from the time of informed consent to the participants' end of study visit with the Principle Investigator.
    Adverse event reporting additional description
    Adverse events were collected at Mid and End of study visits by discussion with the participant. Participant had contact telephone numbers for the PI/research team and a 24 hour ward number as patient support. Please note all adverse events were collected (regardless of whether the adverse event was considered to be caused by the trial drug).
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    WHO ICD10
    Dictionary version
    2016
    Reporting groups
    Reporting group title
    Pramipexole
    Reporting group description
    Participants who received any dose of pramipexole following patient consent

    Reporting group title
    Ropinirole
    Reporting group description
    Any participant who received any dose of ropinirole following consent. Please note there was one additional participant who consented to the study, then had a adverse event to ropinirole (usual prescription). This participant was withdrawn and did not receive trial drugs.

    Serious adverse events
    Pramipexole Ropinirole
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Pramipexole Ropinirole
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 20 (90.00%)
    21 / 22 (95.45%)
    Vascular disorders
    Postural hypotension
    Additional description: Includes "hypotension when sitting and standing"
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 22 (9.09%)
         occurrences all number
    1
    2
    Thrombophlebitis
    Additional description: Thrombophebitis (swollen ankle)
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Epistaxis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Social circumstances
    Work related stress
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Malaise
    Additional description: Includes unwell and fatigue
         subjects affected / exposed
    4 / 20 (20.00%)
    3 / 22 (13.64%)
         occurrences all number
    4
    3
    Excessive sweating
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Swollen extremities
         subjects affected / exposed
    1 / 20 (5.00%)
    3 / 22 (13.64%)
         occurrences all number
    1
    1
    Psychiatric disorders
    Sleep disorder
    Additional description: Includes restless sleep, sleep disturbance, interrupted sleep, insomnia, increased aggressive sleeping behaviour.
         subjects affected / exposed
    5 / 20 (25.00%)
    1 / 22 (4.55%)
         occurrences all number
    5
    1
    Anxiety
         subjects affected / exposed
    1 / 20 (5.00%)
    3 / 22 (13.64%)
         occurrences all number
    1
    3
    Low mood
    Additional description: In association with a medication error (insufficient dose of study drug taken)
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Drowsiness
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    1
    Confusional state
         subjects affected / exposed
    2 / 20 (10.00%)
    1 / 22 (4.55%)
         occurrences all number
    2
    1
    Hallucinations
         subjects affected / exposed
    3 / 20 (15.00%)
    0 / 22 (0.00%)
         occurrences all number
    3
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    Road Traffic accident
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Weight gain
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Angina pectoris
    Additional description: Increased frequency of angina
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Atrial fibrilliation
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Palpitations
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Wheezing
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Breathlessness
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Nervous system disorders
    Tension headache
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Worsening Tremor
         subjects affected / exposed
    3 / 20 (15.00%)
    3 / 22 (13.64%)
         occurrences all number
    3
    3
    Increased jerky movements
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Increased Parkinson's symptoms
    Additional description: Includes shaky from hand to foot. One report was in association with a medication error (insufficient dose of study drug taken).
         subjects affected / exposed
    0 / 20 (0.00%)
    3 / 22 (13.64%)
         occurrences all number
    0
    3
    Coordination disorder
    Additional description: Includes slow movements and tripping
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    2
    Vivid dreams
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    0
    Memory impairment
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    Balance disorder
    Additional description: In association with a fall
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Increased dizziness and giddiness
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    2
    Headache
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    1
    Ear and labyrinth disorders
    Otitis media
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Ear wax
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Umbilical hernia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Bloating
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    1
    Gagging
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Hiccups
    Additional description: Increased hiccups
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    1
    Hypersensitivity rash
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Paraesthesia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Aching legs
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Back pain
    Additional description: Exacerbation of back pain
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Over eating
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Apr 2013
    Protocol 4: Changes Includes: • Addition of nearest dosage of tablets of pramipexole to medication conversation table (Protocol section 6.2.1). • Update to appendix 5 (conversion table for transferring patients between trial treatments), reference used to match table in body of protocol. • Exclusion criteria: clarification of hepatic impairment added (3X Upper limit of normal) for clarity. • Exclusion criteria: Added all doses that fall outside inclusion criteria • Updated process details for prescribing IMPs and pharmacy records • Added the research nurse to phone patient 48 hours after starting IMP to monitor adverse events. • Mid study visit: Blood tests to be performed if not completed in previous 3 months
    03 Sep 2013
    Amendment to IMP from branded drugs to use of generics (this was consistent with original Clinical Trial Authorisation from the MHRA)
    20 Jan 2014
    Protocol V6 changes includes: • Updates to IMPs (Pramipexole base (not salt) now referred to throughout the protocol, minor change to IMP conversion tables). • Further pharmacy/prescribing related details updated. • Pharmacy will keep records of destroyed IMPs • Barriers to recruitment questionnaire sub study added
    06 May 2014
    Due to recruitment difficulties, use of Participant Identification Centres were added to the protocol. This amendment included new documents to support Participants to be identified via local GP practices.
    06 May 2014
    To further aid the identification of potential participants: Update to the protocol to include use of Community Pharmacies to raise awareness of the clinical trial (Participant Identification activity) Supportive documents for the barriers to recruitment sub-study approved
    21 Jul 2014
    • Clarifications to the consent process (PI to take consent) • Amendment to perform the blood test at screening for all patients • Changes to the emergency contact number • New study documents include: • New drug Swap trial cards (to ensure participants had written information regarding swapping from one IMP to the other).
    23 Oct 2014
    Request to temporarily halt recruitment accepted by MHRA. An error was identified in the patient information sheet regarding the side effect profile of the study drugs. Decision made by sponsor to temporarily halt further recruitment until the patient information sheet had been corrected.
    28 Oct 2014
    REC accepted temporarily halt to recruitment and approved new documentation. MHRA accepted updated protocol, change to reference safety information and trial restart on 10-Dec-2014. • Update to reference safety information (RSI) (from section 4.8 of the summary of product characteristics (SmPC) Requip XL April 2012 to the latest available SPC 13 March 2014 and from section 4.8 Mirapexin 1.05mg prolonged release July 2011 (one dosage selected) to the latest available Mirapexin 3.15mg prolonged release February 2014. • Clarification to inclusion / Exclusion criteria:  Inclusion criteria clarified that patients who are not receiving adjuvant therapy also meet the inclusion criteria  Added detail of the liver function tests examined locally (for clarity)  Renal impairment exclusion criteria is clarified to be creatinine clearance or eGFR.  Clarification that planned or current participation in a drug trial is not permitted • Mid visit assessment on mental capacity  As per the recommendation of the CI/PI, the mini mental state examination will not be repeated at mid visit as failing some aspects of the test can be upsetting to the patient. Clinical judgement will be used to assess that the patient has mental capacity to continue. • Correction to side effect profile of the IMPs (protocol and Patient information Sheet)  Section 7.5.1 of protocol now includes the section 4.8 of the RSI for both IMPs • Minimum stabilisation period on IMP stated as 4 weeks. • Correction to Patient Information Sheet regarding the side effect profile of the IMPs.
    28 Oct 2014
    Approval of two (monotherapy and adjuvant therapy) patient letters describing the error in patient information sheet concerning the incorrect side effect profile of the IMPs.
    28 Nov 2014
    REC approved Trial restart. MHRA approved trial restart on 10-December-2014 (along with the updated protocol) (see REC amendment dated 28-Oct-2014)

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    22 Sep 2014
    Note trial temporarily stopped from 22-Sep-2014 to 18-Dec-2014 due to an error identified in the participant information sheet regarding errors in the side effect profile of the trial drugs in the participant information sheet. This error was rectified and the trial was restarted on 18-Dec-2014.
    18 Dec 2014

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The trial failed to meet the target recruitment of 50 participants. This was a feasibility study and a number a protocol deviations were reported. People with Parkinson’s should not change their medication based on this trial.
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