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    Clinical Trial Results:
    A randomised, placebo-controlled, multicentre phase IIb study evaluating the efficacy of pirepemat on falls frequency in patients with Parkinson’s disease

    Summary
    EudraCT number
    		 2019-002627-16
    Trial protocol
    		 DE   PL   FR   ES   NL  
    Global end of trial date
    09 Jan 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Jun 2026
    First version publication date
    11 Jun 2026
    Other versions
    Summary report(s)
    		 Study report synopsis
    IRL752C003_Poster ADPD2026_REACT-PD results

    Trial information

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    Trial identification
    Sponsor protocol code
    IRL752C003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05258071
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Integrative Research Laboratories Sweden AB (IRLAB)
    Sponsor organisation address
    Arvid Wallgrens Backe 20, Gothenburg, Sweden,
    Public contact
    Clinical Trial Information Desk, Integrative Research Laboratories Sweden AB (IRLAB), +46 31 757 38 00, info@irlab.se
    Scientific contact
    Clinical Trial Information Desk, Integrative Research Laboratories Sweden AB (IRLAB), +46 31 757 38 00, info@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
    19 Mar 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Dec 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Jan 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the effects of pirepemat on fall frequency as compared to placebo.
    Protection of trial subjects
    To monitor safety of the trial subjects, measurements of vital signs, physical examinations, clinical laboratory safety tests and ECGs were performed regularly. Discontinuation protocol was in place if any of the protocol stopping criteria was met.
    Background therapy
    		 All participants are receiving their standard Parkinson's treatment. Parkinson's treatment must be stable for at least 30 days prior to the start of IMP (Investigational Medicinal Product).
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 May 2022
    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
    Netherlands: 1
    Country: Number of subjects enrolled
    Poland: 56
    Country: Number of subjects enrolled
    Spain: 14
    Country: Number of subjects enrolled
    Sweden: 5
    Country: Number of subjects enrolled
    France: 14
    Country: Number of subjects enrolled
    Germany: 14
    Worldwide total number of subjects
    104
    EEA total number of subjects
    104
    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)
    19
    From 65 to 84 years
    85
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment was open from Jun-2022 to Sep-2024 at 38 trial centers across France, Germany, Poland, Spain, Sweden and the Netherlands.

    Pre-assignment
    Screening details
    		 Screening period was between 4 and 6 weeks from the date of signature of the ICF by the subject. Participants were screened for eligibility according to study-specific inclusion/exclusion criteria. Key inclusion criteria: Parkinson's disease diagnostic with stable treatment, MoCA score between 10 and 26, 2 falls during the 4 weeks before baseline

    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
    		 Pirepemat 300 mg
    Arm description
    		 Pirepemat tablets, dose 50 mg, 2 tablets t.i.d. for 84 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    IRL757
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    IRL757, 50 mg tablet, 2 tablets t.i.d.

    Arm title
    		 Pirepemat 600 mg
    Arm description
    		 Pirepemat tablets, dose 100 mg, 2 tablets t.i.d. for 84 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    IRL757
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    IRL757, 100 mg tablet, 2 tablets t.i.d.

    Arm title
    		 Placebo
    Arm description
    		 Placebo tablets, 2 tablets t.i.d. for 84 days
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo, 2 tablets t.i.d.

    Number of subjects in period 1
    		Pirepemat 300 mg Pirepemat 600 mg Placebo
    Started
    35
    35
    34
    Completed
    32
    28
    30
    Not completed
    3
    7
    4
         Adverse event, serious fatal
    -
    -
    1
         Consent withdrawn by subject
    1
    4
    2
         Adverse event, non-fatal
    1
    1
    1
         Elevation of Liver Enzymes
    1
    2
    -

    Baseline characteristics

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

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 104 104
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        geometric mean (standard deviation)
    		 71.6 ( 7.10 ) -
    Gender categorical
    Units: Subjects
        Female
    		 41 41
        Male
    		 63 63
    Subject analysis sets

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set includes all patients who are randomized and treated, who receive at least 1 dose of IMP and who provide at least 1 post baseline efficacy assessment on primary or secondary endpoints.

    Subject analysis sets values
    		 Full Analysis Set
    Number of subjects
    101
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        geometric mean (standard deviation)
    71.6 ( 7.10 )
    Gender categorical
    Units: Subjects
        Female
    41
        Male
    60

    End points

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    End points reporting groups
    Reporting group title
    Pirepemat 300 mg
    Reporting group description
    		 Pirepemat tablets, dose 50 mg, 2 tablets t.i.d. for 84 days

    Reporting group title
    Pirepemat 600 mg
    Reporting group description
    		 Pirepemat tablets, dose 100 mg, 2 tablets t.i.d. for 84 days

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo tablets, 2 tablets t.i.d. for 84 days

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set includes all patients who are randomized and treated, who receive at least 1 dose of IMP and who provide at least 1 post baseline efficacy assessment on primary or secondary endpoints.

    Primary: Change in fall frequency as assessed with fall diary from baseline period to the end of treatment.

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    End point title
    		 Change in fall frequency as assessed with fall diary from baseline period to the end of treatment.
    End point description
    The number of falls is being recorded using a paper fall diary (Patient Reported Outcome, PRO). Change in falls is reported as a relative fall rate (fall rate at evaluation period / fall rate at baseline period).
    End point type
    Primary
    End point timeframe
    For the Baseline period, all collected data before first IMP administration are considered for baseline fall rate (min 28 days). For the fall rate at Evaluation period, the data collected during the last 28 days with full IMP dose are considered.
    End point values
    		 Pirepemat 300 mg Pirepemat 600 mg Placebo
    Number of subjects analysed
    31
    28
    31
    Units: % of baseline fall rate
    77
    64
    69
    Statistical analysis title
    		 Analysis 1 - MMRM with ranked relative fall rate
    Statistical analysis description
    Comparing high dose group vs placebo, using Mixed Model Repeated Measurements with ranked relative fall rate as dependent variable, with treatment group and acetylcholinesterase as covariates.
    Comparison groups
    Placebo v Pirepemat 600 mg
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.5753
    Method
    		 Ranked Relative Fall Rate MMRM
    Parameter type
    		 Median ratio
    Point estimate
    0.973
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.706
         upper limit
    		 1.274
    Notes
    [1] - Estimate and confidence interval for primary analysis for Median Relative Fall Rate Ratio ((median relative fall rate of Pirepemat Group) / (median relative fall rate of placebo group)), is computed through bootstrap procedure (10000 estimates) described in the SAP. Confidence intervals are the 2.5 and 97.5% percentile values.
    Statistical analysis title
    		 Analysis 2 - Negative binomial regression
    Statistical analysis description
    Comparing high dose group vs placebo by means of negative binomial regression.
    Comparison groups
    Pirepemat 600 mg v Placebo
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 = 0.5156
    Method
    		 Negative binomial regression
    Parameter type
    		 Relative Fall Rate treatment/placebo
    Point estimate
    0.854
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.53
         upper limit
    		 1.376
    Notes
    [2] - Fall rate frequency and confidence intervals are calculated from a negative binomial regression in SAS Proc Genmod, with baseline days, log(fall rate at baseline) and strata for cholinesterase inhibitor use as covariates, treatment group as a factor

    Secondary: Change in the total score of MDS-UPDRS part 2 (M-EDL) from baseline to end of full dose treatment (with pirepemat compared to placebo)

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    End point title
    		 Change in the total score of MDS-UPDRS part 2 (M-EDL) from baseline to end of full dose treatment (with pirepemat compared to placebo)
    End point description
    The total scoring range is 0-52, where a higher score indicates more severe impact on Motor Aspects of Experiences of Daily Living (M-EDL). The endpoint measure is the difference between the score measured at the last full dose visit and the score measured at baseline visit.
    End point type
    Secondary
    End point timeframe
    Baseline to end of full dose treatment (week 11)
    End point values
    		 Pirepemat 300 mg Pirepemat 600 mg Placebo
    Number of subjects analysed
    32
    28
    29
    Units: point
    0
    1
    2
    Statistical analysis title
    		 Analysis MDS-UPDRS
    Comparison groups
    Pirepemat 600 mg v Placebo
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.04
         upper limit
    		 3.65

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected from signature of ICF to completion of trial (20-22 weeks). The AE presented here in the results are only treatment-emergent AEs (meaning AE occurring once the study treatment was started).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.1
    Reporting groups
    Reporting group title
    Pirepemat 300 mg
    Reporting group description
    		 Pirepemat tablets, dose 50 mg, 2 tablets t.i.d. for 84 days

    Reporting group title
    Pirepemat 600 mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Pirepemat 300 mg Pirepemat 600 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 35 (11.43%)
    4 / 35 (11.43%)
    3 / 34 (8.82%)
         number of deaths (all causes)
    0
    0
    1
         number of deaths resulting from adverse events
    0
    0
    1
    Investigations
    Cystatin C increased
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Glomerular filtration rate decreased
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Papillary thyroid cancer
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Bradykinesia
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neurodegenerative disorder
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Gastrointestinal disorders
    Duodenal ulcer
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatitis cholestatic
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatitis toxic
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Delusion
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Pirepemat 300 mg Pirepemat 600 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    26 / 35 (74.29%)
    27 / 35 (77.14%)
    18 / 34 (52.94%)
    Investigations
    Hepatic enzyme increased
         subjects affected / exposed
    7 / 35 (20.00%)
    4 / 35 (11.43%)
    0 / 34 (0.00%)
         occurrences all number
    7
    4
    0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 35 (0.00%)
    2 / 35 (5.71%)
    0 / 34 (0.00%)
         occurrences all number
    0
    2
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 35 (0.00%)
    3 / 34 (8.82%)
         occurrences all number
    2
    0
    3
    Head injury
         subjects affected / exposed
    4 / 35 (11.43%)
    1 / 35 (2.86%)
    0 / 34 (0.00%)
         occurrences all number
    4
    1
    0
    Joint injury
         subjects affected / exposed
    1 / 35 (2.86%)
    1 / 35 (2.86%)
    2 / 34 (5.88%)
         occurrences all number
    1
    1
    2
    Fall
         subjects affected / exposed
    0 / 35 (0.00%)
    2 / 35 (5.71%)
    1 / 34 (2.94%)
         occurrences all number
    0
    2
    1
    Skin abrasion
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 35 (2.86%)
    0 / 34 (0.00%)
         occurrences all number
    2
    1
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 35 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    2
    0
    1
    Surgical and medical procedures
    Dental implantation
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    0
    0
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 35 (8.57%)
    1 / 35 (2.86%)
    1 / 34 (2.94%)
         occurrences all number
    3
    1
    1
    Dizziness
         subjects affected / exposed
    1 / 35 (2.86%)
    3 / 35 (8.57%)
    0 / 34 (0.00%)
         occurrences all number
    1
    3
    0
    Freezing phenomenon
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 35 (2.86%)
    0 / 34 (0.00%)
         occurrences all number
    2
    1
    0
    Somnolence
         subjects affected / exposed
    0 / 35 (0.00%)
    2 / 35 (5.71%)
    1 / 34 (2.94%)
         occurrences all number
    0
    2
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 35 (2.86%)
    2 / 35 (5.71%)
    0 / 34 (0.00%)
         occurrences all number
    1
    2
    0
    Fatigue
         subjects affected / exposed
    0 / 35 (0.00%)
    2 / 35 (5.71%)
    0 / 34 (0.00%)
         occurrences all number
    0
    2
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    4 / 35 (11.43%)
    3 / 35 (8.57%)
    0 / 34 (0.00%)
         occurrences all number
    4
    3
    0
    Nausea
         subjects affected / exposed
    1 / 35 (2.86%)
    3 / 35 (8.57%)
    3 / 34 (8.82%)
         occurrences all number
    1
    3
    3
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 35 (5.71%)
    3 / 35 (8.57%)
    3 / 34 (8.82%)
         occurrences all number
    2
    3
    3
    Pain in extremity
         subjects affected / exposed
    3 / 35 (8.57%)
    1 / 35 (2.86%)
    0 / 34 (0.00%)
         occurrences all number
    3
    1
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 35 (2.86%)
    0 / 34 (0.00%)
         occurrences all number
    2
    1
    0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    1 / 35 (2.86%)
    3 / 35 (8.57%)
    0 / 34 (0.00%)
         occurrences all number
    1
    3
    0
    COVID-19
         subjects affected / exposed
    0 / 35 (0.00%)
    2 / 35 (5.71%)
    1 / 34 (2.94%)
         occurrences all number
    0
    2
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 35 (2.86%)
    2 / 35 (5.71%)
    0 / 34 (0.00%)
         occurrences all number
    1
    2
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Sep 2023
    Correction of discrepancies and clarifications and update following implementation of urgent safety measure (adding a visit for safety laboratory assessments at week 3). Removal of two safety follow-up visits.
    23 Jan 2024
    Re-estimation of the sample size. Revision of analysis model for the primary endpoint. Clarification of the primary outcome measure and revision of secondary, tertiary objectives classification. Correction of discrepancies.

    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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