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    Clinical Trial Results:
    Double-blind, randomized, crossover design for evaluation of efficacy and safety of methylphenidate in cognition in patients with Parkinson's disease using electrophysiological measures

    Summary
    EudraCT number
    		 2020-005073-28
    Trial protocol
    		 ES  
    Global end of trial date
    14 Dec 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jan 2025
    First version publication date
    01 Jan 2025
    Other versions
    Summary report(s)
    		 MPD2024

    Trial information

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    Trial identification
    Sponsor protocol code
    ParKMetil/001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Rey Juan Carlos
    Sponsor organisation address
    Avenida de Atenas,, Alcorcon, Spain, 28922
    Public contact
    Sponsor , Universidad Rey Juan Carlos, nfogelson@gmail.com
    Scientific contact
    Sponsor , Universidad Rey Juan Carlos, nfogelson@gmail.com
    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
    14 Dec 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Feb 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Dec 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To examine the cognitive effects of a single 20 mg dose of methylphenidate (MPD) in non-demented patients with Parkinson's disease, using behavioural and electrophysiological measures, in a randomized, double-blind, placebo-controlled, single-dose, cross-over clinical trial study. Specifically we evaluated reaction time and event-related potentials associated with different types of stimuli and compared these for the MPD and placebo sessions in the patients.
    Protection of trial subjects
    Patients with the following criteria were excluded from the study: dementia, clinically significant depression, patients who have suffered from hallucinations, delusions or psychosis, severe motor fluctuations and prominent ON dyskinesia, unbalanced arterial hypertension of more than 140/80 during siting on the day of the study, uncontrolled hypertension, hepatic or renal failure, uncontrolled malignancy, or untreated glaucoma, and patients treated with Monoamine Oxidase Inhibitors.
    Background therapy
    		 Patients were asked to take their regular medication on the day of the experiment, including Parkinsonian treatment with levopdopa.
    Evidence for comparator
    		 We recorded EEG, during the performance of the task, in PD patients after the administration of methylphenidate (MPD) and placebo. Each subject performed a total of two recording sessions, one after the administration of 20 mg of MPD and another after the administration of a placebo saccharine pill. Each session was performed on a different day, 7 to 14 days apart, using the same procedures. EEG recordings were performed 90 mins after the administration of either the MPD or placebo pill. The order of administration of MPD versus placebo was randomized and counterbalanced across the subjects. All the sessions were recorded in the morning hours to control for environmental effects on attention, while the patients were in ON state.
    Actual start date of recruitment
    01 Feb 2022
    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
    Spain: 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)
    5
    From 65 to 84 years
    17
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Forty patients diagnosed with Parkinson's disease in Hospital Universitario Fundación Alcorcon, Spain fit the inclusion criteria and were contacted to participate in the study between February 2022 and 2024.

    Pre-assignment
    Screening details
    		 Patients diagnosed with PD fit the inclusion criteria and were contacted to participate in the study. Fourteen patients refused to participate, and four patients were unable to perform at least one of the recording sessions due to high blood pressure measurements on the day of the experiment.

    Pre-assignment period milestones
    Number of subjects started
    		 40 [1]
    Number of subjects completed
    		 22

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Physician decision: 4
    Reason: Number of subjects
    		 Consent withdrawn by subject: 14
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Fourteen subjects did not give their consent to proceed with the trial. Fouir subjects could not proceed on the day of the recordings due to high blood pressure.
    Period 1
    Period 1 title
    Methylphenidate
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst, Carer, Assessor
    Blinding implementation details
    Patients, clinicians assesing the patients, the researchers performing the EEG recordings and analyzing the data were blinded to the administration of either metghylphenidate or a placebo saccharine pill.

    Arms
    Arm title
    		 Methylphenidate
    Arm description
    		 Parkinson's disease patients administered 20 mg of methylphenidate
    Arm type
    		 Experimental

    Investigational medicinal product name
    Methylphenidate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    20 mg of methylphenidate swallowed orally

    Number of subjects in period 1
    		Methylphenidate
    Started
    22
    Completed
    22
    Period 2
    Period 2 title
    Placebo
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst, Carer, Assessor

    Arms
    Arm title
    		 Placebo
    Arm description
    		 Placebo session
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saccarine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 pill of saccarine swallowed with water

    Number of subjects in period 2
    		Placebo
    Started
    22
    Completed
    22

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Methylphenidate
    Reporting group description
    		 Twenty two patients performing two crossover sessions

    Reporting group values
    		 Methylphenidate Total
    Number of subjects
    		 22 22
    Age categorical
    Parkinson's diasease patients age range 30-78 years
    Units: Subjects
    Age continuous
    Parkinson's disease patients 30-78 years old
    Units: years
        arithmetic mean (standard deviation)
    		 68 ( 8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 10 10
        Male
    		 12 12

    End points

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    End points reporting groups
    Reporting group title
    Methylphenidate
    Reporting group description
    		 Parkinson's disease patients administered 20 mg of methylphenidate
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo session

    Primary: Change between MPD and placebo

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    End point title
    		 Change between MPD and placebo
    End point description
    End point type
    Primary
    End point timeframe
    P3b latency for targets for MPD session and placebo session in each subject
    End point values
    		 Methylphenidate Placebo
    Number of subjects analysed
    22
    22
    Units: ms
        arithmetic mean (standard deviation)
    401 ( 51 )
    432 ( 57 )
    Statistical analysis title
    		 Comparison of P3b latency between MPD and placebo
    Comparison groups
    Placebo v Methylphenidate
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 ≤ 0.05
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    No adverse events
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 regular
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Methylphenidate
    Reporting group description
    		 Parkinson's disease patients administered 20 mg of methylphenidate

    Reporting group title
    Placebo
    Reporting group description
    		 Parkinson's disease patients administered saccarine placebo pill

    Serious adverse events
    		 Methylphenidate Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 22 (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
    		 Methylphenidate Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 22 (0.00%)
    Cardiac disorders
    Dizziness
    Additional description: One adverse event was reported by a patient who experienced dizziness due to high blood pressure after completing the recording session, where methylphenidate was administered.
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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