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    Clinical Trial Results:
    A phase Ib, open label study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending oral doses of Rimeporide in patients with Duchenne Muscular Dystrophy

    Summary
    EudraCT number
    		 2015-002530-50
    Trial protocol
    		 ES   GB   FR   IT  
    Global end of trial date
    20 Dec 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Jul 2018
    First version publication date
    07 Jul 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EspeRare_RIM_001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02710591
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    QED Clinical Services
    Sponsor organisation address
    The Old School Newport Road, Woughton Park, Milton Keynes, United Kingdom,
    Public contact
    Director of Clinical Operations, QED Clinical Services, +44 1908 251 480, nmaruf@qed-clinical.com
    Scientific contact
    Director of Clinical Operations, QED Clinical Services, +44 1908 251 480, nmaruf@qed-clinical.com
    Sponsor organisation name
    EspeRare Foundation
    Sponsor organisation address
    14 chemin des Aulx, Plan les Ouates, Switzerland, CH-1228
    Public contact
    Caroline Kant, EspeRare Foundation, kant.caroline@esperare.org
    Scientific contact
    Florence Porte-Thomé, EspeRare Foundation, porte.florence@esperare.org
    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
    20 Dec 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Dec 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Dec 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary objective: To determine the preliminary safety and tolerability profile of multiple oral administrations of rimeporide. Secondary objective:
 To evaluate the pharmacokinetic profile of rimeporide in pediatric patients with DMD.
    Protection of trial subjects
    Prior to enrolment subjects received a full explanation of the nature and purpose of the study, the safety of the drug under investigation, and discussion of any potential therapeutic benefit, and that they were free to withdraw from the study at any time without prejudice. An informed consent form approved by the IEC was signed by the subject and legal representative and the Investigator before any study-related procedures were performed. The Investigator provided copies of the signed informed consent to the subject or legal representative, and the original was retained by the Investigator.
    Background therapy
    		 Patients on a stable dose of corticosteroids at least 6 months prior to baseline
    Evidence for comparator
    		 No comparator used
    Actual start date of recruitment
    17 Mar 2016
    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
    Spain: 3
    Country: Number of subjects enrolled
    United Kingdom: 5
    Country: Number of subjects enrolled
    France: 6
    Country: Number of subjects enrolled
    Italy: 6
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    20
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The recruitment period varied depending on the recruitment speed ; started in March 2016 to November 2017. it was competitive among the 4 sites: France, Spain, Italy and UK. A time interval of at least 1 week was maintained between adminstration of first dose in the first 3 patients of each cohort. It was extended to all patients for cohort 4.

    Pre-assignment
    Screening details
    		 Screening was carried out within 4 week prior to first administration of rimeporide (SD1) to enable confirmation of patient eligibility and following the signature of the Informed Consent Form.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1
    Arm description
    		 5 patients with a body weight less than or equal to 30kg at baseline were administered 50 mg TID. Patients with a body weight more than 30kg at baseline were administered 75 mg TID. Each patient received rimeporide during 4 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rimeporide
    Investigational medicinal product code
    EMD 87 580
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Eligible subjects received rimeporide 3 times per day (TID) over 4 weeks. Rimeporide was supplied to the sites in hard gel capsules at 25mg in bottles of 50 capsules each. The drug was appropriately labeled in the local language and adapted to the national requirements.

    Arm title
    		 Cohort 2
    Arm description
    		 5 patients with a body weight less than or equal to 30kg at baseline were administered 100 mg TID. Patients with a body weight more than 30kg at baseline were administered 150 mg TID. Each patient received rimeporide during 4 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rimeporide
    Investigational medicinal product code
    EMD 87 580
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Eligible subjects received rimeporide 3 times per day (TID) over 4 weeks. Rimeporide was supplied to the sites in hard gel capsules at 50mg in bottles of 50 capsules each. The drug was appropriately labeled in the local language and adapted to the national requirements.

    Arm title
    		 Cohort 3
    Arm description
    		 5 patients with a body weight less than or equal to 30kg at baseline were administered 150 mg TID. Patients with a body weight more than 30kg at baseline were administered 200 mg TID. Each patient received rimeporide during 4 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rimeporide
    Investigational medicinal product code
    EMD 87 580
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Elligible subjects received rimeporide 3 times per day (TID) over 4 weeks. Rimeporide was supplied to the sites in hard gel capsules at 50mg in bottles of 50 capsules each. The drug was appropriately labeled in the local language and adapted to the national requirements.

    Arm title
    		 Cohort 4
    Arm description
    		 5 patients with a body weight less than or equal to 30kg at baseline were administered 200 mg TID. Patients with a body weight more than 30kg at baseline were administered 300 mg TID. Each patient received rimeporide during 4 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rimeporide
    Investigational medicinal product code
    EMD 87 580
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Eligible subjects received rimeporide 3 times per day (TID) over 4 weeks. Rimeporide was supplied to the sites in hard gel capsules at 50mg in bottles of 50 capsules each. The drug was appropriately labeled in the local language and adapted to the national requirements.

    Number of subjects in period 1
    		Cohort 1 Cohort 2 Cohort 3 Cohort 4
    Started
    5
    5
    5
    5
    Completed
    5
    5
    5
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1
    Reporting group description
    		 5 patients with a body weight less than or equal to 30kg at baseline were administered 50 mg TID. Patients with a body weight more than 30kg at baseline were administered 75 mg TID. Each patient received rimeporide during 4 weeks.

    Reporting group title
    Cohort 2
    Reporting group description
    		 5 patients with a body weight less than or equal to 30kg at baseline were administered 100 mg TID. Patients with a body weight more than 30kg at baseline were administered 150 mg TID. Each patient received rimeporide during 4 weeks

    Reporting group title
    Cohort 3
    Reporting group description
    		 5 patients with a body weight less than or equal to 30kg at baseline were administered 150 mg TID. Patients with a body weight more than 30kg at baseline were administered 200 mg TID. Each patient received rimeporide during 4 weeks.

    Reporting group title
    Cohort 4
    Reporting group description
    		 5 patients with a body weight less than or equal to 30kg at baseline were administered 200 mg TID. Patients with a body weight more than 30kg at baseline were administered 300 mg TID. Each patient received rimeporide during 4 weeks

    Reporting group values
    		 Cohort 1 Cohort 2 Cohort 3 Cohort 4 Total
    Number of subjects
    		 5 5 5 5 20
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 5 5 5 5 20
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0 0
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Age continuous
    Age of patient at Screening
    Units: years
        arithmetic mean (standard deviation)
    		 8.4 ± 1.7 8.2 ± 1.5 8.8 ± 1.6 9.2 ± 0.4 -
    Gender categorical
    Units: Subjects
        Male
    		 5 5 5 5 20
    Ethnicity/Race
    Units: Subjects
        White
    		 5 4 5 5 19
        Black or African American
    		 0 1 0 0 1

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1
    Reporting group description
    		 5 patients with a body weight less than or equal to 30kg at baseline were administered 50 mg TID. Patients with a body weight more than 30kg at baseline were administered 75 mg TID. Each patient received rimeporide during 4 weeks.

    Reporting group title
    Cohort 2
    Reporting group description
    		 5 patients with a body weight less than or equal to 30kg at baseline were administered 100 mg TID. Patients with a body weight more than 30kg at baseline were administered 150 mg TID. Each patient received rimeporide during 4 weeks

    Reporting group title
    Cohort 3
    Reporting group description
    		 5 patients with a body weight less than or equal to 30kg at baseline were administered 150 mg TID. Patients with a body weight more than 30kg at baseline were administered 200 mg TID. Each patient received rimeporide during 4 weeks.

    Reporting group title
    Cohort 4
    Reporting group description
    		 5 patients with a body weight less than or equal to 30kg at baseline were administered 200 mg TID. Patients with a body weight more than 30kg at baseline were administered 300 mg TID. Each patient received rimeporide during 4 weeks

    Primary: Primary: overview of adverse events

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    End point title
    		 Primary: overview of adverse events [1]
    End point description
    End point description: No hypothesis testing performed. Observations are given for the safety population (all patients who received at least one dose of study drug). Categorical data are presented with the number of subjects with at least one event for the following selections: • treatment-emergent AEs (TEAEs) • study drug-related TEAEs (ADRs) • serious TEAEs • study drug-related serious TEAEs (serious ADRs) • TEAEs leading to withdrawal • study drug-related TEAEs (ADRs) leading to withdrawal • serious TEAEs leading to withdrawal • TEAEs leading to death as outcome
    End point type
    Primary
    End point timeframe
    The safety reporting period is defined as the interval between the time of first dosing and the end of the follow-up period. Adverse events falling into this time window are classified as treatment-emergent Adverse Events (TEAE)
    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: Descriptive statistics only (open label study with analysis of the safety profile of Rimeporide as primary endpoint)
    End point values
    		 Cohort 1 Cohort 2 Cohort 3 Cohort 4
    Number of subjects analysed
    5
    5
    5
    5
    Units: Subjects
        Treatment emergent adverse events
    2
    1
    5
    4
        Emergent adverse drug reactions
    0
    0
    0
    2
        Serious treatment emergent adverse events
    0
    0
    1
    0
        Serious emergent adverse event drug reactions
    0
    0
    0
    0
        TEAEs leading to withdrawal
    0
    0
    0
    0
        TEAEs leading to death
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: PK profile of Rimeporide-Cmax

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    End point title
    		 PK profile of Rimeporide-Cmax
    End point description
    PK samples were collected according to the following schedule: - At Day 1: for half of the patients: just before first administration, and one sample in each of the following time frames after the first dose: o 0.5 to 1h after dosing, o 1 to 2h after dosing, o 2.5 to 3.5h after dosing, o 6h after dosing - At Day 1: for the other half of the patients: just before first administration, and one sample in each of the following time frames after the second dose: o 0.5 to 1h after dosing, o 1 to 2h after dosing, o 2.5 to 3.5h after dosing, o 6h after dosing Finally, at week 4 (Day 28) after the last dose: o 0.5 to 1h after dosing, o 6h after dosing
    End point type
    Secondary
    End point timeframe
    PK samples were collected on Study Day 1 (SD1) and on W4 visit (day of last rimeporide adminstration) according to a PK profile allocation. See Description section for the details
    End point values
    		 Cohort 1 Cohort 2 Cohort 3 Cohort 4
    Number of subjects analysed
    4
    5
    5
    5
    Units: ng/mL
    arithmetic mean (standard deviation)
        Cmax
    1299 ± 419
    1974 ± 955
    2658 ± 667
    3663 ± 825
    No statistical analyses for this end point

    Secondary: PK profile of Rimeporide-AUC

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    End point title
    		 PK profile of Rimeporide-AUC
    End point description
    PK samples were collected according to the following schedule: - At Day 1: for half of the patients: just before first administration, and one sample in each of the following time frames after the first dose: o 0.5 to 1h after dosing, o 1 to 2h after dosing, o 2.5 to 3.5h after dosing, o 6h after dosing - At Day 1: for the other half of the patients: just before first administration, and one sample in each of the following time frames after the second dose: o 0.5 to 1h after dosing, o 1 to 2h after dosing, o 2.5 to 3.5h after dosing, o 6h after dosing Finally, at week 4 (Day 28) after the last dose: o 0.5 to 1h after dosing, o 6h after dosing
    End point type
    Secondary
    End point timeframe
    PK samples were collected on Study Day 1 (SD1) and on W4 visit (day of last rimeporide administration) according to a PK profile allocation. See Description section for the details
    End point values
    		 Cohort 1 Cohort 2 Cohort 3 Cohort 4
    Number of subjects analysed
    4
    5
    5
    5
    Units: ng.h/mL
    arithmetic mean (standard deviation)
        AUC
    9530 ± 1388
    16975 ± 5565
    23565 ± 3237
    32013 ± 6879
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Full study period
    Adverse event reporting additional description
    Treatment Emergent AEs and SAEs (starting on SD1)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Cohort 1
    Reporting group description
    		 -

    Reporting group title
    Cohort 2
    Reporting group description
    		 -

    Reporting group title
    Cohort 3
    Reporting group description
    		 -

    Reporting group title
    Cohort 4
    Reporting group description
    		 -

    Serious adverse events
    		 Cohort 1 Cohort 2 Cohort 3 Cohort 4
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomitting
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Cohort 1 Cohort 2 Cohort 3 Cohort 4
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 5 (40.00%)
    1 / 5 (20.00%)
    5 / 5 (100.00%)
    4 / 5 (80.00%)
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vascular disorders
    Flushing
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    1
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    2 / 5 (40.00%)
    2 / 5 (40.00%)
         occurrences all number
    1
    0
    2
    3
    Dizziness
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Presyncope
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    1
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    1
    Ear and labyrinth disorders
    Tympanic membrane perforation
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    2 / 5 (40.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    2
    1
    Vomiting
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    1
    1
    Mouth ulceration
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    1 / 5 (20.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    1
    1
    Oropharyngeal pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    2 / 5 (40.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    2
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Dec 2015
    Main Changes: Inclusion criteria: Ability to swallow capsules has been added Exclusion criteria : "Use of antibiotics with predominant renal secretion (e.g., cephalosporins), immunosuppressive agents exception corticosteroids, continuous treatment with non-steroidal, anti- inflammatory drugs (NSAIDs), or lithium" has been added. "Patients with specific contraindication to MRI (e.g.: metallic foreign body, claustrophobia, etc.)" has been extended to all patients Secondary objectives and Exploratory objectives: The biomarkers endpoints in the study are reclassified as exploratory. Recruitment plan: For safety reasons, the SMC has advised that a time interval of at least one week should be maintained between administrations of the first dose in the first three patients in each cohort.

    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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