Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    SMT C1100 - A Phase 1, Open-label, Single and Multiple Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Paediatric Patients with Duchenne Muscular Dystrophy

    Summary
    EudraCT number
    		 2013-002115-99
    Trial protocol
    		 GB  
    Global end of trial date
    23 Apr 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Jul 2016
    First version publication date
    05 Aug 2015
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    SMT C11002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Summit Corporation plc
    Sponsor organisation address
    85b Park Drive, Milton Park, Abingdon, Oxfordshire, United Kingdom, OX14 4RY
    Public contact
    Clinical Trial Information, Summit Corporation plc, dmd@summitplc.com
    Scientific contact
    Clinical Trial Information, Summit Corporation plc, dmd@summitplc.com
    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
    03 Jul 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Apr 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Apr 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to determine the safety and tolerability of single and multiple oral doses of SMT C1100 in patients with Duchenne Muscular Dystrophy (DMD).
    Protection of trial subjects
    Following discussion of the study with study site personnel, the patient’s parents/legal guardians signed a study-specific informed consent form in the presence of a study site physician or a suitably trained deputy to indicate that they were freely giving their informed consent. An age-specific informed assent form was reviewed with the patient by the site personnel and the patient’s parents/legal guardians. Written or verbal assent of the patient was considered for inclusion and was documented within the patient medical notes. A safety review was performed following each initial dosing, and there was a 48 hour period between dosing of each patient. In addition, there was at least 2 weeks between each dose escalation, to allow a satisfactory review of safety, tolerability and pharmacokinetics data. The project team led by the Sponsor’s Chief Medical Officer and Chief Investigator conducted the safety reviews.
    Background therapy
    		 During the study, systemic corticosteroids (stable dose for 2 months prior to start of study), bisphosphonates, beta blockers, angiotensin-receptor blockers and angiotensin converting enzyme inhibitors were permitted.
    Evidence for comparator
    		 Not applicable; no comparators were used.
    Actual start date of recruitment
    02 Dec 2013
    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
    United Kingdom: 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)
    12
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The first informed consent was given on 2nd December 2013, and the date of last patient last visit was 23rd April 2014. The final post-study observation was made on 8th May 2014.

    Pre-assignment
    Screening details
    		 Screening was performed within 28 days prior to initial dosing.

    Pre-assignment period milestones
    Number of subjects started
    		 13 [1]
    Number of subjects completed
    		 12

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Screen failure according to exclusion criteria: 1
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Thirteen patients were screened for inclusion in the study, however one patient was excluded as a screen failure. Twelve patients were dosed with SMT C1100, and data are reported for these patients.
    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A
    Arm description
    		 Patients in Group A were dosed with SMT C1100 according to the following regimen: Day 1: 50 mg/kg (single dose at 0 hours) Days 2 to 10: 50 mg/kg twice daily (at approximately 0 hours and 12 hours) Day 11: 50 mg/kg (single dose at 0 hours)
    Arm type
    		 Experimental

    Investigational medicinal product name
    SMT C1100
    Investigational medicinal product code
    SMT C1100
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Aqueous microfluidised suspension of SMT C1100 (200 mg/g) was administered using oral dosing syringes, according to the treatment group regimen.

    Arm title
    		 Group B
    Arm description
    		 Following completion of Group A dosing and safety/pharmacokinetics review, patients in Group B were dosed according to the following regimen: Day 1: 100 mg/kg (single dose at 0 hours) Days 2 to 10: 100 mg/kg twice daily (at approximately 0 hours and 12 hours) Day 11: 100 mg/kg (single dose at 0 hours)
    Arm type
    		 Experimental

    Investigational medicinal product name
    SMT C1100
    Investigational medicinal product code
    SMT C1100
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Aqueous microfluidised suspension of SMT C1100 (200 mg/g) was administered using oral dosing syringes, according to the treatment group regimen.

    Arm title
    		 Group C
    Arm description
    		 Following completion of Group B dosing and safety/pharmacokinetics review, patients in Group C were dosed according to the following regimen: Day 1: 100 mg/kg (single dose at 0 hours) Days 2 to 10: 100 mg/kg three times daily, with 5 to 7 hours between doses where possible (0 hours, 5 to 7 hours and 10 to 14 hours; after breakfast, lunch and evening meal, respectively) Day 11: 100 mg/kg (single dose at 0 hours)
    Arm type
    		 Experimental

    Investigational medicinal product name
    SMT C1100
    Investigational medicinal product code
    SMT C1100
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Aqueous microfluidised suspension of SMT C1100 (200 mg/g) was administered using oral dosing syringes, according to the treatment group regimen.

    Number of subjects in period 1
    		Group A Group B Group C
    Started
    4
    4
    4
    Completed
    4
    4
    4

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Patients in Group A were dosed with SMT C1100 according to the following regimen: Day 1: 50 mg/kg (single dose at 0 hours) Days 2 to 10: 50 mg/kg twice daily (at approximately 0 hours and 12 hours) Day 11: 50 mg/kg (single dose at 0 hours)

    Reporting group title
    Group B
    Reporting group description
    		 Following completion of Group A dosing and safety/pharmacokinetics review, patients in Group B were dosed according to the following regimen: Day 1: 100 mg/kg (single dose at 0 hours) Days 2 to 10: 100 mg/kg twice daily (at approximately 0 hours and 12 hours) Day 11: 100 mg/kg (single dose at 0 hours)

    Reporting group title
    Group C
    Reporting group description
    		 Following completion of Group B dosing and safety/pharmacokinetics review, patients in Group C were dosed according to the following regimen: Day 1: 100 mg/kg (single dose at 0 hours) Days 2 to 10: 100 mg/kg three times daily, with 5 to 7 hours between doses where possible (0 hours, 5 to 7 hours and 10 to 14 hours; after breakfast, lunch and evening meal, respectively) Day 11: 100 mg/kg (single dose at 0 hours)

    Reporting group values
    		 Group A Group B Group C Total
    Number of subjects
    		 4 4 4 12
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 4 4 4 12
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 9 (6 to 11) 8 (6 to 8) 8 (6 to 10) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0 0 0
        Male
    		 4 4 4 12
    Age of DMD diagnosis
    Units: years
        arithmetic mean (full range (min-max))
    		 5 (4 to 8) 4 (2 to 6) 4 (3 to 5) -
    Time since DMD diagnosis
    Units: years
        arithmetic mean (full range (min-max))
    		 4 (2 to 5) 4 (2 to 6) 4 (3 to 5) -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Patients in Group A were dosed with SMT C1100 according to the following regimen: Day 1: 50 mg/kg (single dose at 0 hours) Days 2 to 10: 50 mg/kg twice daily (at approximately 0 hours and 12 hours) Day 11: 50 mg/kg (single dose at 0 hours)

    Reporting group title
    Group B
    Reporting group description
    		 Following completion of Group A dosing and safety/pharmacokinetics review, patients in Group B were dosed according to the following regimen: Day 1: 100 mg/kg (single dose at 0 hours) Days 2 to 10: 100 mg/kg twice daily (at approximately 0 hours and 12 hours) Day 11: 100 mg/kg (single dose at 0 hours)

    Reporting group title
    Group C
    Reporting group description
    		 Following completion of Group B dosing and safety/pharmacokinetics review, patients in Group C were dosed according to the following regimen: Day 1: 100 mg/kg (single dose at 0 hours) Days 2 to 10: 100 mg/kg three times daily, with 5 to 7 hours between doses where possible (0 hours, 5 to 7 hours and 10 to 14 hours; after breakfast, lunch and evening meal, respectively) Day 11: 100 mg/kg (single dose at 0 hours)

    Primary: Safety and tolerability of single and multiple oral doses of SMT C1100

    		 Close Top of page
    End point title
    		 Safety and tolerability of single and multiple oral doses of SMT C1100 [1]
    End point description
    The condition of each patient was monitored throughout the study. When resident at the study sites any signs or symptoms were observed and elicited at least once a day by open questioning. Patients were also encouraged to spontaneously report adverse events occurring at any other time during the study by documenting in their diary and/or verbally reporting them to Investigator staff when at the study site.
    End point type
    Primary
    End point timeframe
    Duration of the study.
    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: The primary endpoint for this study was assessment of safety and tolerability. Appropriate descriptive statistics for the safety data were determined, but no inferential statistical analyses were performed on safety data.
    End point values
    		 Group A Group B Group C
    Number of subjects analysed
    4
    4
    4
    Units: Number of events
        Patients with treatment-emergent adverse events
    4
    4
    3
        Number of treatment-emergent adverse events
    15
    9
    7
        Patients with serious adverse events
    0
    0
    0
        Patients discontinued owing to adverse events
    0
    0
    0
        Patients with severe adverse events
    0
    0
    0
    No statistical analyses for this end point

    Secondary: AUC 0-tlast SMT C1100

    		 Close Top of page
    End point title
    		 AUC 0-tlast SMT C1100
    End point description
    Area under the plasma concentration versus time curve from time zero up to the last quantifiable concentration (Day 1 only).
    End point type
    Secondary
    End point timeframe
    Day 1 (following single oral dosing).
    End point values
    		 Group A Group B Group C
    Number of subjects analysed
    4
    4
    4
    Units: ng.h/mL
        geometric mean (geometric coefficient of variation)
    330 ± 147.5
    547 ± 177.6
    385 ± 107.4
    No statistical analyses for this end point

    Secondary: AUC 0-tau SMT C1100

    		 Close Top of page
    End point title
    		 AUC 0-tau SMT C1100
    End point description
    Area under the plasma concentration versus time curve over a dosing interval. The dosing interval tau was 12 hours for twice daily dosing and 6 hours for three times daily dosing regimens.
    End point type
    Secondary
    End point timeframe
    Day 11 (following multiple oral dosing).
    End point values
    		 Group A Group B Group C
    Number of subjects analysed
    4
    4
    4
    Units: ng.h/mL
        geometric mean (geometric coefficient of variation)
    128 ± 158.7
    187 ± 247.7
    87.2 ± 130.7
    No statistical analyses for this end point

    Secondary: Cmax Day 1 SMT C1100

    		 Close Top of page
    End point title
    		 Cmax Day 1 SMT C1100
    End point description
    Maximum observed plasma concentration.
    End point type
    Secondary
    End point timeframe
    Day 1 (following single oral dosing).
    End point values
    		 Group A Group B Group C
    Number of subjects analysed
    4
    4
    4
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    77.6 ± 145.6
    145 ± 78.7
    88.5 ± 77.9
    No statistical analyses for this end point

    Secondary: Cmax Day 11 SMT C1100

    		 Close Top of page
    End point title
    		 Cmax Day 11 SMT C1100
    End point description
    Maximum observed plasma concentration.
    End point type
    Secondary
    End point timeframe
    Day 11 (following multiple oral dosing).
    End point values
    		 Group A Group B Group C
    Number of subjects analysed
    4
    4
    4
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    26.7 ± 81.8
    31.1 ± 198
    20.4 ± 147.8
    No statistical analyses for this end point

    Secondary: tmax Day 1 SMT C1100

    		 Close Top of page
    End point title
    		 tmax Day 1 SMT C1100
    End point description
    Time of maximum observed plasma concentration.
    End point type
    Secondary
    End point timeframe
    Day 1 (following single oral dosing).
    End point values
    		 Group A Group B Group C
    Number of subjects analysed
    4
    4
    4
    Units: hour
        median (full range (min-max))
    1.02 (1 to 4.02)
    1.58 (1.03 to 2.05)
    1 (0.98 to 1)
    No statistical analyses for this end point

    Secondary: tmax Day 11 SMT C1100

    		 Close Top of page
    End point title
    		 tmax Day 11 SMT C1100
    End point description
    Time of maximum observed plasma concentration.
    End point type
    Secondary
    End point timeframe
    Day 11 (following multiple oral dosing).
    End point values
    		 Group A Group B Group C
    Number of subjects analysed
    4
    4
    4
    Units: hour
        median (full range (min-max))
    1.51 (1 to 6)
    2.01 (1 to 3)
    1 (1 to 1)
    No statistical analyses for this end point

    Secondary: t1/2 Day 1 SMT C1100

    		 Close Top of page
    End point title
    		 t1/2 Day 1 SMT C1100
    End point description
    Apparent terminal elimination half life.
    End point type
    Secondary
    End point timeframe
    Day 1 (following single oral dosing).
    End point values
    		 Group A Group B Group C
    Number of subjects analysed
    4
    4
    4
    Units: hour
        arithmetic mean (standard deviation)
    6.15 ± 3.07
    4.98 ± 2.21
    9.99 ± 7.55
    No statistical analyses for this end point

    Secondary: t1/2 Day 11 SMT C1100

    		 Close Top of page
    End point title
    		 t1/2 Day 11 SMT C1100
    End point description
    Apparent terminal elimination half life.
    End point type
    Secondary
    End point timeframe
    Day 11 (following multiple oral dosing).
    End point values
    		 Group A Group B Group C
    Number of subjects analysed
    3
    4
    3
    Units: hour
        arithmetic mean (standard deviation)
    7.99 ± 6.42
    6.81 ± 3.83
    6.92 ± 2.64
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    The condition of each patient was monitored throughout the study. In addition, when resident at the study sites any signs or symptoms were observed and elicited at least once a day by open questioning.
    Adverse event reporting additional description
    Patients were also encouraged to spontaneously report adverse events occurring at any other time during the study by documenting in their diary and/or verbally reporting them to Investigator staff when at the study site. Unique preferred terms for adverse events were only counted once per patient.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Patients in Group A were dosed with SMT C1100 according to the following regimen: Day 1: 50 mg/kg (single dose at 0 hours) Days 2 to 10: 50 mg/kg twice daily (at approximately 0 hours and 12 hours) Day 11: 50 mg/kg (single dose at 0 hours)

    Reporting group title
    Group B
    Reporting group description
    		 Following completion of Group A dosing and safety/pharmacokinetics review, patients in Group B were dosed according to the following regimen: Day 1: 100 mg/kg (single dose at 0 hours) Days 2 to 10: 100 mg/kg twice daily (at approximately 0 hours and 12 hours) Day 11: 100 mg/kg (single dose at 0 hours)

    Reporting group title
    Group C
    Reporting group description
    		 Following completion of Group B dosing and safety/pharmacokinetics review, patients in Group C were dosed according to the following regimen: Day 1: 100 mg/kg (single dose at 0 hours) Days 2 to 10: 100 mg/kg three times daily, with 5 to 7 hours between doses where possible (0 hours, 5 to 7 hours and 10 to 14 hours; after breakfast, lunch and evening meal, respectively) Day 11: 100 mg/kg (single dose at 0 hours)

    Serious adverse events
    		 Group A Group B Group C
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Group A Group B Group C
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 4 (100.00%)
    4 / 4 (100.00%)
    3 / 4 (75.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    General disorders and administration site conditions
    Energy increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Faeces pale
         subjects affected / exposed
    1 / 4 (25.00%)
    3 / 4 (75.00%)
    3 / 4 (75.00%)
         occurrences all number
    1
    3
    3
    Diarrhoea
         subjects affected / exposed
    2 / 4 (50.00%)
    1 / 4 (25.00%)
    1 / 4 (25.00%)
         occurrences all number
    2
    1
    1
    Abdominal pain upper
         subjects affected / exposed
    2 / 4 (50.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    0
    Abdominal pain
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Constipation
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Dyspepsia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Flatulence
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Frequent bowel movements
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Toothache
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Sneezing
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Eczema
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Rash
         subjects affected / exposed
    2 / 4 (50.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    0
    Rash erythematous
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Psychiatric disorders
    Abnormal behaviour
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Mood swings
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0

    More information

    		 Close Top of page

    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.
    Not applicable.
    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.

    European Medicines Agency © 1995-Sat May 04 12:27:38 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA