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    Clinical Trial Results:
    A randomised, double-blind, placebo-controlled, phase IIA study evaluating the efficacy and tolerability of IRL790 in Parkinson's disease dyskinesia

    Summary
    EudraCT number
    		 2017-003458-18
    Trial protocol
    		 GB   SE  
    Global end of trial date
    12 Jun 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Mar 2020
    First version publication date
    20 Mar 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IRL790C003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03368170
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Integrative Research Laboratories AB (IRLAB)
    Sponsor organisation address
    Arvid Wallgrens backe 20, Gothenburg, Sweden, 413 46
    Public contact
    Clinical Trials Information, Integrative Research Laboratories AB (IRLAB), +46 (0)707601691, joakim.tedroff@irlab.se
    Scientific contact
    Clinical Trials Information, Integrative Research Laboratories AB (IRLAB), +46 (0)707601691, joakim.tedroff@irlab.se
    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 Nov 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Jun 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Jun 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of IRL790 in Parkinson's disease dyskinesia
    Protection of trial subjects
    This study was conducted in compliance with International Conference for Harmonisation Good Clinical Practice (ICH GCP) guidelines and with the ethical principles originating in the Declaration of Helsinki. Written informed consent was obtained from all study subjects before any study related procedures were performed. A Data Safety Monitoring Board (DSMB) were used for this study, responsible for reviewing and commenting on the cumulative safety data.
    Background therapy
    		 Patients included in the study had to be on stable anti-Parkinson treatment for at least 30 days prior screening and during the study.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Nov 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Sweden: 15
    Country: Number of subjects enrolled
    United Kingdom: 60
    Worldwide total number of subjects
    75
    EEA total number of subjects
    75
    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)
    28
    From 65 to 84 years
    47
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment period 13 months (12 Apr 18 - 9 May 19). First patient first visit: 12 April 2019. Last patient last visit: 12 June 2019. Participating countries: UK and Sweden. A total of 75 subjects were randomized study (39 on active study drug and 36 on placebo). 72 subjects completed the study (37 on active study drug and 35 on placebo).

    Pre-assignment
    Screening details
    		 The screening period was up to 4 weeks and the treatment period was 4 weeks followed by a follow-up visit 5-8 days after end of treatment. A total of 108 subjects were enrolled in the study and a total of 75 subjects were randomized in the study.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Mesdopetam
    Arm description
    		 Mesdopetam (IRL790). Capsule 2.5 mg. Oral administration b.i.d.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mesdopetam
    Investigational medicinal product code
    IRL790
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    This was a randomized, placebo-controlled study with the patients taking the study drug for 4 weeks at home. Mesdopetam was taken twice daily (5 mg, 7.5 mg or 10 mg b.i.d.) as adjunctive treatment to the patients' regular and stable antiparkinsonian medication. The first two weeks of treatment allowed for per patient titration of study medication to the highest tolerated per patient dose for an additional two weeks. Capsules were to be swallowed intact together with 200 mL of tap water in the morning and in the afternoon approximately 8 hours apart of each administration day. Formulation details: 2.5 mg free base equivalent: White hard Hydroxypropyl Methylcellulose (HPMC) capsule, coni snap size 3, colour with containing IRL790 X 1/2 L-tartrate.

    Arm title
    		 Placebo
    Arm description
    		 Placebo comparator. Matching placebo capsule. Oral administration b.i.d.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    This was a randomized, placebo-controlled study with the patients taking the study drug for 4 weeks at home. Placebo capsules were taken twice daily (b.i.d.) as adjunctive treatment to the patients' regular and stable antiparkinsonian medication. The first two weeks of treatment allowed for per patient titration of study medication to the highest number of placebo capsules (1 capsule x 4) per patient tolerated dose for an additional two weeks. Capsules were to be swallowed intact together with 200 mL of tap water in the morning and in the afternoon approximately 8 hours apart of each administration day. Formulation details: White hard Hydroxypropyl Methylcellulose (HPMC) capsule, coni snap size 3, colour white containing starch.

    Number of subjects in period 1
    		Mesdopetam Placebo
    Started
    39
    36
    Completed
    37
    35
    Not completed
    2
    1
         Adverse event, non-fatal
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Mesdopetam
    Reporting group description
    		 Mesdopetam (IRL790). Capsule 2.5 mg. Oral administration b.i.d.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo comparator. Matching placebo capsule. Oral administration b.i.d.

    Reporting group values
    		 Mesdopetam Placebo Total
    Number of subjects
    		 39 36 75
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 15 13 28
        From 65-84 years
    		 24 23 47
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 65.5 ± 8.9 67.7 ± 7.7 -
    Gender categorical
    Units: Subjects
        Female
    		 20 13 33
        Male
    		 19 23 42
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 0 1 1
        Not Hispanic or Latino
    		 39 35 74
    Race
    Units: Subjects
        Asian
    		 1 0 1
        White
    		 38 35 73
        Unknown or not reported
    		 0 1 1
    Body Mass Index (BMI)
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 26.6 ± 7.2 25.3 ± 4.2 -
    Height
    Units: centimeter
        arithmetic mean (standard deviation)
    		 166.7 ± 10.3 169 ± 9.4 -
    Years with Parkinson's disease
    Units: Years
        arithmetic mean (standard deviation)
    		 10.7 ± 5.9 10.7 ± 4.3 -

    End points

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    End points reporting groups
    Reporting group title
    Mesdopetam
    Reporting group description
    		 Mesdopetam (IRL790). Capsule 2.5 mg. Oral administration b.i.d.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo comparator. Matching placebo capsule. Oral administration b.i.d.

    Primary: The change from baseline to day 28 of treatment (Visit 4) in the sum of the items comprising the Unified Dyskinesia Rating Scale (UDysRS).

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    End point title
    		 The change from baseline to day 28 of treatment (Visit 4) in the sum of the items comprising the Unified Dyskinesia Rating Scale (UDysRS).
    End point description
    The UDysRS is administered to assess dyskinesia. The scoring range is 0-104, where higher score means more dyskinesia.
    End point type
    Primary
    End point timeframe
    The change from baseline to day 28 of treatment (Visit 4).
    End point values
    		 Mesdopetam Placebo
    Number of subjects analysed
    36
    34
    Units: Score on a scale
        least squares mean (confidence interval 95%)
    -4.2 (-7.3 to -1.0)
    -7.0 (-10.3 to -3.8)
    Statistical analysis title
    		 Total UDysRS score
    Statistical analysis description
    Absolute change from baseline to end of treatment.
    Comparison groups
    Mesdopetam v Placebo
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.7
         upper limit
    		 7.5

    Secondary: Change in MDS-UPDRS sum score of questions 4.1 (Time spent with dyskinesias) and 4.2 (Functional impact of dyskinesias) in part IV from baseline to visit 4.

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    End point title
    		 Change in MDS-UPDRS sum score of questions 4.1 (Time spent with dyskinesias) and 4.2 (Functional impact of dyskinesias) in part IV from baseline to visit 4.
    End point description
    Maximum score is 8, where a higher score means more dyskinesia.
    End point type
    Secondary
    End point timeframe
    Change from baseline to visit 4.
    End point values
    		 Mesdopetam Placebo
    Number of subjects analysed
    37
    35
    Units: Score on a scale
        least squares mean (confidence interval 95%)
    -1.3 (-1.8 to 0.8)
    -0.6 (-1.1 to 0.1)
    No statistical analyses for this end point

    Secondary: Change in MDS-UPDRS sum score of parts II+III (Motor aspects of Experiences of Daily living + Motor Examination) from baseline to visit 4.

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    End point title
    		 Change in MDS-UPDRS sum score of parts II+III (Motor aspects of Experiences of Daily living + Motor Examination) from baseline to visit 4.
    End point description
    Minimum value is 0 and maximum value is 124. Higher score mean a worse outcome.
    End point type
    Secondary
    End point timeframe
    Change from baseline to visit 4.
    End point values
    		 Mesdopetam Placebo
    Number of subjects analysed
    37
    35
    Units: score on a scale
        least squares mean (confidence interval 95%)
    -3.0 (-6.5 to 0.6)
    -2.2 (-5.9 to 1.4)
    No statistical analyses for this end point

    Other pre-specified: Change in "ON"-time with troublesome dyskinesia as assessed by patient completed 24-hour diaries, from run-in to visit 4.

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    End point title
    		 Change in "ON"-time with troublesome dyskinesia as assessed by patient completed 24-hour diaries, from run-in to visit 4.
    End point description
    This is a self administered diary where patients assess their motor state every half hour during 24 hours.
    End point type
    Other pre-specified
    End point timeframe
    Change in from run-in to visit 4.
    End point values
    		 Mesdopetam Placebo
    Number of subjects analysed
    37
    34
    Units: Daily hours
        least squares mean (confidence interval 95%)
    -3.3 (-4.3 to 2.4)
    -1.7 (-2.8 to 0.7)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    5 weeks (from the randomization visit to the follow up visit)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Mesdopetam
    Reporting group description
    		 mesdopetam (IRL790). Capsule 2.5 mg, oral administration b.i.d.

    Reporting group title
    Placebo
    Reporting group description
    		 placebo comparator. Identical capsule, oral administration b.i.d.

    Serious adverse events
    		 Mesdopetam Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 36 (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: 5%
    Non-serious adverse events
    		 Mesdopetam Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    29 / 39 (74.36%)
    28 / 36 (77.78%)
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    4 / 39 (10.26%)
    3 / 36 (8.33%)
         occurrences all number
    5
    7
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 39 (5.13%)
    3 / 36 (8.33%)
         occurrences all number
    2
    3
    Dyskinesia
         subjects affected / exposed
    4 / 39 (10.26%)
    2 / 36 (5.56%)
         occurrences all number
    4
    3
    Freezing phenomenon
         subjects affected / exposed
    1 / 39 (2.56%)
    4 / 36 (11.11%)
         occurrences all number
    1
    4
    Gait disturbance
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    2
    Headache
         subjects affected / exposed
    5 / 39 (12.82%)
    5 / 36 (13.89%)
         occurrences all number
    6
    5
    On and off phenomenon
         subjects affected / exposed
    2 / 39 (5.13%)
    1 / 36 (2.78%)
         occurrences all number
    2
    2
    Parkinsonism
    Additional description: In the mesdopetam group, 7 of the parkinsonism adverse events occurred during the titration phase (i.e. the first 2 weeks of study treatment) and only 2 of the parkinsonism event during steady state (i.e. the last two weeks of study treatment.
         subjects affected / exposed
    9 / 39 (23.08%)
    3 / 36 (8.33%)
         occurrences all number
    9
    3
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 39 (5.13%)
    9 / 36 (25.00%)
         occurrences all number
    2
    9
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 39 (0.00%)
    4 / 36 (11.11%)
         occurrences all number
    0
    4
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    2
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    2 / 39 (5.13%)
    2 / 36 (5.56%)
         occurrences all number
    2
    2
    Sleep disorder
         subjects affected / exposed
    3 / 39 (7.69%)
    2 / 36 (5.56%)
         occurrences all number
    3
    2
    Musculoskeletal and connective tissue disorders
    Muscle spasms
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    2
    muscoloskeletal stiffness
         subjects affected / exposed
    1 / 39 (2.56%)
    3 / 36 (8.33%)
         occurrences all number
    1
    4
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    2 / 39 (5.13%)
    2 / 36 (5.56%)
         occurrences all number
    2
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Oct 2017
    Version 2. Updates to section 6.4 "Blinding and randomization".
    14 Nov 2017
    Version 3. Updates to sections "synopsis & schedule of assessments", 8.2.2.4 "MDS-UPDRS", 6.4 "Blinding & randomization", 8.2.2.5.1 "Rush filming protocol", 4.3 "Inclusion/Exclusion criteria", 1.3 "summary of risk management". 2.2 "Secondary objectives", 3.1 "Study design", 7.2 + 7.6 (Visit descriptions), 8.2.2.6 "PKG", 11.7 "Efficacy endpoints", 1.1.2 "Efficacy", abbreviations and contact details to statistics and IRS.
    11 Jun 2018
    Version 4. Updates to sections 8.1.1 "Ethnic origin", 8.1.5 "ECG", 11.4 "Ethnicity", 9 "statistical analysis" and change of statistician.
    24 Jul 2018
    Version 5. Updates to sections 7.8 (updated visit description) and 5.2 "non-permitted concomitant medications".
    14 Jan 2019
    Version 6. Updates to sections 4 "Inclusion/Exclusion criteria", 7.3 "Contraception methods", 4.1 "re-screening clarification" and addition of CTC as Swedish CRO.

    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.
    Technical difficulties in administration of UDysRS objective score. A post-hoc analysis was performed on 41 rush films and showed that 24% of the patients were NOT in ON-phase during the UDysRS part III+IV dyskinesia assessment.
    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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