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    Clinical Trial Results:
    Effects of different concentrations of dexmedetomidine on basal ganglia neuronal activity (local field potentials) in Parkinson's disease.

    Summary
    EudraCT number
    		 2016-002680-34
    Trial protocol
    		 ES  
    Global end of trial date
    28 Nov 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Nov 2021
    First version publication date
    24 Nov 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DEXPAR
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02982512
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Clinica Universidad de Navarra
    Sponsor organisation address
    AVENIDA PÍO XII, Nº 36, PAMPLONA/IRUÑA, Spain, 31008
    Public contact
    UCEC, Clinica Universidad de Navarra, 34 948 255 400, ucicec@unav.es
    Scientific contact
    UCEC, Clinica Universidad de Navarra, 34 948 255 400, ucicec@unav.es
    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
    31 Jan 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Nov 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Nov 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To study and quantify the possible effect of different doses of dexmedetomidine (0.2-0.6 µg/kg/h) on the local field potentials (deep brain activity) in patients with Parkinson´s disease undergoing deep brain stimulation implantion.
    Protection of trial subjects
    NA
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Oct 2016
    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: 12
    Worldwide total number of subjects
    12
    EEA total number of subjects
    12
    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)
    8
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients, of legal age, undergoing DBS placement for Parkinson's disease (NST or GPi) in two stages.

    Pre-assignment
    Screening details
    		 14 patients agreed to participate in the trial, but eventually only 12 patients were exposed to the study drug.

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Treatment
    Arm description
    		 No Intervention: Control recording Recording of local field potentials without drugs from the deep brain stimulator Experimental: Dexmedetomodine recording Recording of local field potentials at different dexmedetomidine concentrations from the deep brain stimulator Intervention: Drug: Dexmedetomidine
    Arm type
    		 Experimental

    Investigational medicinal product name
    DEXMEDETOMIDINE
    Investigational medicinal product code
    Other name
    (S)-4-[1-(2,3-Dimethylphenyl)ethyl]-3H-imidazole
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The administration of the drug will be carried out in a single session for 3 hours and 55 minutes. A loading dose of the drug will be administered (0.5 μg / kg in 10 min) and increasing doses of 0.2, 0.3, 0.4, 0.5 and 0.6 μg / kg / h spaced in periods of time of 45 min.

    Number of subjects in period 1
    		Treatment
    Started
    12
    Completed
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment period
    Reporting group description
    		 -

    Reporting group values
    		 Treatment period Total
    Number of subjects
    		 12 12
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 8 8
        From 65-84 years
    		 4 4
    Gender categorical
    Units: Subjects
        Female
    		 6 6
        Male
    		 6 6

    End points

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    End points reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 No Intervention: Control recording Recording of local field potentials without drugs from the deep brain stimulator Experimental: Dexmedetomodine recording Recording of local field potentials at different dexmedetomidine concentrations from the deep brain stimulator Intervention: Drug: Dexmedetomidine

    Primary: Changes in neuronal activity. Dexmedetomidine.

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    End point title
    		 Changes in neuronal activity. Dexmedetomidine. [1]
    End point description
    A loading dose of the drug will be administered (0.5 μg / kg in 10 min) and increasing doses of 0.2, 0.3, 0.4, 0.5 and 0.6 μg / kg / h spaced in periods of time of 45 min.
    End point type
    Primary
    End point timeframe
    The administration of the drug will be carried out in a single session for 3 hours and 55 minutes.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: With dexmedetomidine infusion, patients became clinically sedated, and at higher doses (0.5-0.6 mg/kg/h) a significant decrease in the characteristic Parkinsonian subthalamic activity was observed (P<0.05 in beta activity). All subjects awoke to external stimulus over a median of 1 (range: 0e9) min, showing full restoration of subthalamic activity. Dexmedetomidine dose administered and plasma levels showed a positive correlation (repeated measures correlation coefficient¼0.504; P<0.001).
    End point values
    		 Treatment
    Number of subjects analysed
    12
    Units: mV/m2
        number (not applicable)
    12
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse events are collected from the time the patient is treated until the end of their follow-up.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 ND
    Dictionary version
    ND
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No adverse events were reported.

    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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