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    Clinical Trial Results:
    Effects of Montelukast on neuroinflammation in Parkinson's Disease. An open-label single-center trial.

    Summary
    EudraCT number
    		 2020-000148-76
    Trial protocol
    		 SE  
    Global end of trial date
    07 Jul 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 May 2023
    First version publication date
    01 May 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    3.0
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Academic Specialist Center
    Sponsor organisation address
    Solnavägen 1E, Stockholm, Sweden, 11365
    Public contact
    Academic Specialist Center, Stockholm Health Care Services, 0046 812367300,
    Scientific contact
    Academic Specialist Center, Stockholm Health Care Services, 0046 812367300,
    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
    01 Jan 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Jul 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Jul 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Safety and tolerability of Montelukast treatment in Parkinson's disease.
    Protection of trial subjects
    Study subjects were treated with Montelukast, an approved drug for 12 weeks. Dosage was higher than in regular clinical practice. Adverse events were closely monitored. Other examinations did not differ from regular clinical practice for patients with Parkinson's disease.
    Background therapy
    		 Regular dopaminergic treatment for Parkinson's disease.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Feb 2021
    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
    Sweden: 15
    Worldwide total number of subjects
    15
    EEA total number of subjects
    15
    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)
    7
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Candidates for the trial will be patients followed at the Academic Specialist Centre, Stockholm, a highly specialized outpatient clinic for parkinsonian disorders. More than 600 patients with PD are treated at the Academic Specialist Centrum.

    Pre-assignment
    Screening details
    		 Patients will be screened using the history of their Parkinson’s disease, supported by any available clinical correspondence according to usual standard of care. Participants will be considered eligible for enrolment in this trial if they fulfil all the inclusion criteria and none of the exclusion criteria.

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    All participants received Montelukast treatment.

    Arms
    Arm title
    		 Baseline
    Arm description
    		 Only one arm. 40 mg of Montelukast daily.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Montelukast
    Investigational medicinal product code
    Other name
    Singulair
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2 tabletts of 10 mg Montelukast were taken by the subject at morning and evening for a total daily dose of 40 mg.

    Number of subjects in period 1
    		Baseline
    Started
    15
    Completed
    15
    Period 2
    Period 2 title
    12 weeks
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 12 weeks of Montelukast
    Arm description
    		 Only one arm. 40 mg of Montelukast daily.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Montelukast
    Investigational medicinal product code
    Other name
    Singulair
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2 tabletts of 10 mg Montelukast were taken by the subject at morning and evening for a total daily dose of 40 mg.

    Number of subjects in period 2
    		12 weeks of Montelukast
    Started
    15
    Completed
    15

    Baseline characteristics

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

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 15 15
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 7 7
        From 65-84 years
    		 8 8
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 65 (63 to 69) -
    Gender categorical
    Units: Subjects
        Female
    		 8 8
        Male
    		 7 7

    End points

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    End points reporting groups
    Reporting group title
    Baseline
    Reporting group description
    		 Only one arm. 40 mg of Montelukast daily.
    Reporting group title
    12 weeks of Montelukast
    Reporting group description
    		 Only one arm. 40 mg of Montelukast daily.

    Primary: • Safety and tolerability of Montelukast in PD patients

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    End point title
    		 • Safety and tolerability of Montelukast in PD patients [1]
    End point description
    End point type
    Primary
    End point timeframe
    Between baseline and 12 weeks of treatment
    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: Primary endpoint was safety and tolerability. All participants finished the trial. No meaningful statistical analysis can be made from the count of adverse events since there is no control group.
    End point values
    		 Baseline 12 weeks of Montelukast
    Number of subjects analysed
    15
    15
    Units: Adverse events
    0
    10
    Attachments
    		 Untitled (Filename: Adverse events.pdf)
    No statistical analyses for this end point

    Secondary: • Microglia activation in the brain measured as measured by [11C]PBR28 PET

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    End point title
    		 • Microglia activation in the brain measured as measured by [11C]PBR28 PET
    End point description
    Pooled grey matter binding of TSPO PET before and after treatment.
    End point type
    Secondary
    End point timeframe
    Between baseline and 12 weeks of treatment
    End point values
    		 Baseline 12 weeks of Montelukast
    Number of subjects analysed
    13
    13
    Units: Mean Vt
        arithmetic mean (standard deviation)
    4.25 ( 2.0 )
    4.17 ( 1.44 )
    Statistical analysis title
    		 Paired t-test
    Comparison groups
    12 weeks of Montelukast v Baseline
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.8 [2]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [2] - Non significant.

    Secondary: Changes in clinical rating scales

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    End point title
    		 Changes in clinical rating scales
    End point description
    Changes in MDS-UPDRS part 1-4, MoCA, BDI, NMSQuest, PDQ-39.
    End point type
    Secondary
    End point timeframe
    Between baseline and 12 weeks.
    End point values
    		 Baseline 12 weeks of Montelukast
    Number of subjects analysed
    15
    15
    Units: mean score
    arithmetic mean (standard deviation)
        MDS-UPDRS 1
    7.20 ( 4.55 )
    4.87 ( 3.46 )
        MDS-UPDRS 2
    6.87 ( 6.14 )
    5.20 ( 4.38 )
        MDS-UPDRS 3
    17.33 ( 17.33 )
    14.53 ( 8.53 )
        MDS-UPDRS 4
    1.73 ( 1.44 )
    1.60 ( 1.3 )
        MoCA
    28.33 ( 1.23 )
    29.07 ( 1.10 )
        BDI
    5.93 ( 4.95 )
    4.67 ( 3.56 )
        NMSQuest
    5.13 ( 3.93 )
    5.27 ( 3.26 )
        PDQ-39
    9.76 ( 8.86 )
    7.95 ( 7.16 )
    Statistical analysis title
    		 MoCA
    Statistical analysis description
    Before and after treatment
    Comparison groups
    12 weeks of Montelukast v Baseline
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.021
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 NMSQuest
    Statistical analysis description
    Before and after treatment.
    Comparison groups
    12 weeks of Montelukast v Baseline
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.685
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 PDQ-39
    Statistical analysis description
    Before and after treatment
    Comparison groups
    12 weeks of Montelukast v Baseline
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.053
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 MDS-UPDRS part 1
    Statistical analysis description
    Before and after treatment
    Comparison groups
    12 weeks of Montelukast v Baseline
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 MDS-UPDRS part 2
    Statistical analysis description
    Before and after treatment.
    Comparison groups
    12 weeks of Montelukast v Baseline
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.015
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 MDS-UPDRS Part 3
    Statistical analysis description
    Before and after treatment.
    Comparison groups
    12 weeks of Montelukast v Baseline
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.024
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 MDS-UPDRS Part 4
    Statistical analysis description
    Before and after treatment.
    Comparison groups
    12 weeks of Montelukast v Baseline
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.758
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 BDI
    Statistical analysis description
    Before and after treatment.
    Comparison groups
    12 weeks of Montelukast v Baseline
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.038
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Montelukast levels in plasma and CSF

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    End point title
    		 Montelukast levels in plasma and CSF
    End point description
    End point type
    Secondary
    End point timeframe
    Between baseline and 12-weeks of treatment.
    End point values
    		 Baseline 12 weeks of Montelukast
    Number of subjects analysed
    13
    13
    Units: ng/l
    arithmetic mean (standard deviation)
        Plasma
    0 ( 0 )
    1621.26 ( 361.11 )
        CSF
    0 ( 0 )
    3.66 ( 1.31 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Telephone inquiry two weeks after baseline, 4 week follow-up visit, 6 week telephone inquiry, 9 week telephone inquiry and lastly at 12 week final visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Bioportal MedDRA
    Dictionary version
    2022AB
    Reporting groups
    Reporting group title
    All participants
    Reporting group description
    		 Only one arm in the study. All exposed to trial treatment.

    Serious adverse events
    		 All participants
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 15 (6.67%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Vascular disorders
    Pulmonary embolism
    Additional description: 1 patient got an pulmonary embolism after immobilisation post-op. It was not deemed connected to IMP. The condition resolved with anti-coagulant therapy.
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 All participants
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 15 (60.00%)
    Injury, poisoning and procedural complications
    Catheter site hematoma
    Additional description: From arterial catheter placed for PET examination
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    2
    Surgical and medical procedures
    Lumbar puncture headache
         subjects affected / exposed
    4 / 15 (26.67%)
         occurrences all number
    4
    Nervous system disorders
    Tremor
    Additional description: Worsening of Parkinsonian tremor.
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Gastrointestinal disorders
    Stools loose
         subjects affected / exposed
    3 / 15 (20.00%)
         occurrences all number
    3
    Psychiatric disorders
    Fatigue
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Musculoskeletal stiffness
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    1
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1

    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.
    Small sample size of 15 patients. No control group. Short treatment period. The primary endpoint was reached however and we plan a larger RCT based on these results.
    For support, Contact us.
    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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