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    Clinical Trial Results:
    A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson’s Disease Experiencing End of Dose “Wearing-Off”

    Summary
    EudraCT number
    2016-003961-25
    Trial protocol
    DE   GB   HU   ES   CZ   IT  
    Global end of trial date
    16 Jan 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    30 Jan 2019
    First version publication date
    30 Jan 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    10TOZ-CL06
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03051607
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    IND Number: 78230
    Sponsors
    Sponsor organisation name
    Acorda Therapeutics
    Sponsor organisation address
    420 Saw Mill River Road, Ardsley, United States, 10502
    Public contact
    Christopher Kenny, Senior Vice President - Medical Affairs , Acorda Therapeutics , 914 326-5775, ckenney@acorda.com
    Scientific contact
    Christopher Kenny, Senior Vice President - Medical Affairs , Acorda Therapeutics , 914 326-5775, ckenney@acorda.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
    16 Jan 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Jan 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Jan 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the safety and tolerability of tozadenant in levodopa-treated PD patients experiencing motor fluctuations.
    Protection of trial subjects
    Conduct of the study must be approved by an appropriately constituted IRB or IEC. Approval is required for the study protocol, investigational drug brochure, protocol amendments, informed consent forms, patient information sheets, and advertising materials. For each study patient, written informed consent will be obtained prior to any protocol-related activities. As part of this procedure, the principal investigator or one of his/her associates must explain orally and in writing the nature, duration, and purpose of the study, and the action of the drug in such a manner that the patient is aware of the potential risks, inconveniences, or adverse effects that may occur. The patient should be informed that he/she may withdraw from the study at any time, and the patient will receive all information that is required by local regulations and ICH guidelines. The principal investigator will provide the Sponsor or its representative with a copy of the IRB/IEC-approved informed consent form prior to the start of the study.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    25 May 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
    Spain: 1
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    Hungary: 1
    Country: Number of subjects enrolled
    Italy: 6
    Country: Number of subjects enrolled
    Canada: 1
    Country: Number of subjects enrolled
    United States: 51
    Worldwide total number of subjects
    66
    EEA total number of subjects
    14
    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)
    27
    From 65 to 84 years
    39
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    A total of 66 patients were enrolled in 27 study centers across 6 countries and were included in the Safety Set (SS) as well as the Full Analysis Set (FAS).

    Pre-assignment
    Screening details
    A total of 66 patients were enrolled in 27 study centers across 6 countries.

    Period 1
    Period 1 title
    52 Weeks (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Arm title
    Tozadenant
    Arm description
    120 mg BID
    Arm type
    Experimental

    Investigational medicinal product name
    Tozadenant
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    120 mg BID Oral tablet

    Number of subjects in period 1
    Tozadenant
    Started
    66
    Completed
    0
    Not completed
    66
         Consent withdrawn by subject
    8
         Death
    2
         Adverser Events
    6
         Lost to follow-up
    1
         Sponsor terminated study
    49

    Baseline characteristics

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

    Reporting group values
    52 Weeks Total
    Number of subjects
    66 66
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    27 27
        From 65-84 years
    39 39
    Gender categorical
    Units: Subjects
        Female
    16 16
        Male
    50 50

    End points

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    End points reporting groups
    Reporting group title
    Tozadenant
    Reporting group description
    120 mg BID

    Primary: The Safety and tolerability of Tozadenant in Levodopa-treated Parkinson Disease patients experiencing motor fluctuations.

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    End point title
    The Safety and tolerability of Tozadenant in Levodopa-treated Parkinson Disease patients experiencing motor fluctuations. [1]
    End point description
    The primary objective of this study was to evaluate the safety and tolerability of tozadenant in levodopa-treated PD patients experiencing motor fluctuations. A total of 66 patients were enrolled in 27 study centers across 6 countries: USA, United Kingdom, Italy, Canada, Spain and Hungary, and were included in the Safety Set (SS). A total of 60 out of 66 enrolled patients completed up to Week 2, 44 completed Week 4, 22 completed Week 12, and 4 completed Week 24.
    End point type
    Primary
    End point timeframe
    24 Weeks due to early termination of 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: Descriptive statistics were provided for this study.
    End point values
    Tozadenant
    Number of subjects analysed
    66
    Units: Participants
        Subjects with at least one treatment-emergent AE
    46
        Subjects with at least one related TEAE
    33
        Subjects discontinuing study drug due to an AE
    7
        Subjects with at least one SAE
    5
        Subjects with at least one life-threatening SAE
    5
        Subjects with AE leading to death
    2
    No statistical analyses for this end point

    Secondary: Effects of Tozadenant on the Occurrence of Daytime Drowsiness by Using the Epworth Sleepiness Scale.

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    End point title
    Effects of Tozadenant on the Occurrence of Daytime Drowsiness by Using the Epworth Sleepiness Scale.
    End point description
    The Secondary objectives was to evaluate the effects of tozadenant on the occurrence of daytime drowsiness by using the Epworth Sleepiness scale. The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness that is measured by use of a short questionnaire. A score within the range 0−9 is considered to be normal while a score within the range of 10−24 would indicate that medical help should be solicited. 60 out of 66 patients completed up to Week 2, 44 completed Week 4, 22 completed Week 12, and 4 completed Week 24.
    End point type
    Secondary
    End point timeframe
    24 Weeks due to early termination of study.
    End point values
    Tozadenant
    Number of subjects analysed
    66
    Units: Score on a scale
    median (standard deviation)
        Baseline
    7.9 ( 5.32 )
        Week 2
    7.4 ( 5.29 )
        Week 6
    8.5 ( 4.72 )
        Week 12
    10.0 ( 3.53 )
        Week 24
    12.0 ( 4.08 )
        Early Termination
    7.9 ( 5.08 )
        Safety Follow-up
    7.3 ( 4.95 )
    No statistical analyses for this end point

    Secondary: Effects of Tozadenant on the Occurrence of Suicidality Using the Columbia-Suicide Severity Scale (C-SSRS) Summarized by Visit.

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    End point title
    Effects of Tozadenant on the Occurrence of Suicidality Using the Columbia-Suicide Severity Scale (C-SSRS) Summarized by Visit.
    End point description
    The Columbia Suicide Severity Rating Scale (C-SSRS) is an example of an acceptable instrument that maps to the Columbia Classification Algorithm for Suicide Assessment (C-CASA), directly classifying events of interest into one of 11 categories of suicidal ideation and behavior. Completion of the scale can be based entirely on patient interview, but integration of information from other sources (such as family and friends, significant others, caregivers, health professionals, and medical records) is also allowed. A total of 60 out of 66 enrolled patients completed up to Week 2, 44 completed Week 4, 22 completed Week 12, and 4 completed Week 24.
    End point type
    Secondary
    End point timeframe
    24 Weeks due to early termination of study.
    End point values
    Tozadenant
    Number of subjects analysed
    66
    Units: Participants
        Screening - Lifetime: Suicidal Ideation
    66
        Screening - Lifetime: Suicidal Behavior
    66
        Screening - Past 5 years: Suicidal Behavior
    64
        Screening - Past 6 months: Suicidal Ideation
    64
        Baseline - Since last visit: Suicidal Ideation
    66
        Baseline - Since last visit: Suicidal Behavior
    66
        Week 2 - Since last visit: Suicidal Ideation
    60
        Week 2 - Since last visit: Suicidal Behavior
    60
        Week 6 - Since last visit: Suicidal Ideation
    44
        Week 6 - Since last visit: Suicidal Behavior
    44
        Week 12 - Since last visit: Suicidal Ideation
    22
        Week 12 - Since last visit: Suicidal Behavior
    22
        Week 24 - Since last visit: Suicidal Ideation
    4
        Week 24 - Since last visit: Suicidal Behavior
    4
        Early Termination: Suicidal Ideation
    62
        Early Termination: Suicidal Behavior
    62
        Safety Follow-up: Suicidal Ideation
    57
        Safety Follow-up: Suicidal Behavior
    57
    No statistical analyses for this end point

    Secondary: Effects of Tozadenant on the occurrence of impulsive behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)

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    End point title
    Effects of Tozadenant on the occurrence of impulsive behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
    End point description
    The Minnesota Impulsive Disorders Interview (MIDI) 8 is a global instrument that includes questions for compulsive gambling, buying, and sexual behavior (as well as other disorders not reported to occur in PD). The mMIDI consists of 5 modules: compulsive buying, compulsive gambling, compulsive eating, hypersexuality and punding. Positive Answer: Any answer other than “no” on any question is considered a “yes”/positive answer. Negative Module: A module is considered negative if the patient’s answer to a gateway (initial) question is “no” or if a patient answers “yes” to a gateway question and “no” to all of the remaining answers after the gateway question in that module. Positive Module: A module is considered positive if a patient gives a positive answer (No = 0, rarely = 1, occasionally = 2, frequently = 3) to any question after the gateway (initial) question in one or more of the 5 modules.
    End point type
    Secondary
    End point timeframe
    24 Weeks due to early termination of study.
    End point values
    Tozadenant
    Number of subjects analysed
    66
    Units: Participants
        Buying Disorder - Screening - Negative
    66
        Buying Disorder - Screening - Positive
    0
        Buying Disorder - Week 2 - Negative
    59
        Buying Disorder - Week 2 - Positive
    1
        Buying Disorder - Week 6 - Negative
    43
        Buying Disorder - Week 6 - Positive
    1
        Buying Disorder - Week 12 - Negative
    22
        Buying Disorder - Week 12 - Positive
    0
        Buying Disorder - Week 24 - Negative
    4
        Buying Disorder - Week 24 - Positive
    0
        Buying Disorder - Early Termination - Neg
    60
        Buying Disorder - Early Termination - Pos
    2
        Buying Disorder - Safety Follow-up - Negative
    56
        Buying Disorder - Safety Follow-up - Positive
    1
        Compulsive Gambling - Screening - Negative
    65
        Compulsive Gambling - Screening - Positive
    1
        Compulsive Gambling - Week 2 - Negative
    59
        Compulsive Gambling - Week 2 - Positive
    1
        Compulsive Gambling - Week 6 - Negative
    44
        Compulsive Gambling - Week 6 - Positive
    0
        Compulsive Gambling - Week 12 - Negative
    22
        Compulsive Gambling - Week 12 - Positive
    0
        Compulsive Gambling - Week 24 - Negative
    4
        Compulsive Gambling - Week 24 - Positive
    0
        Compulsive Gambling - Early Termination - Negative
    61
        Compulsive Gambling - Early Termination - Positive
    1
        Compulsive Gambling - Safety Follow-up - Negative
    56
        Compulsive Gambling - Safety Follow-up - Positive
    1
        Compulsive Sexual Behavior - Screening - Negative
    66
        Compulsive Sexual Behavior - Screening - Positive
    0
        Compulsive Sexual Behavior - Week 2 - Negative
    60
        Compulsive Sexual Behavior - Week 2 - Positive
    0
        Compulsive Sexual Behavior - Week 6 - Negative
    44
        Compulsive Sexual Behavior - Week 6 - Positive
    0
        Compulsive Sexual Behavior - Week 12 - Negative
    22
        Compulsive Sexual Behavior - Week 12 - Positive
    0
        Compulsive Sexual Behavior - Week 24 - Negative
    4
        Compulsive Sexual Behavior - Week 24 - Positive
    0
        Compulsive Sexual Behavior - Early Termination-Neg
    60
        Compulsive Sexual Behavior - Early Termination-Pos
    2
        Compulsive Sexual Behavior - Safety Follow-up -Neg
    56
        Compulsive Sexual Behavior - Safety Follow-up-Pos
    1
        Compulsive Eating Module - Screening - Negative
    66
        Compulsive Eating Module - Screening - Positive
    0
        Compulsive Eating Module - Week 2 - Negative
    60
        Compulsive Eating Module - Week 2 - Positive
    0
        Compulsive Eating Module - Week 6 - Negative
    43
        Compulsive Eating Module - Week 6 - Positive
    1
        Compulsive Eating Module - Week 12 - Negative
    22
        Compulsive Eating Module - Week 12 - Positive
    0
        Compulsive Eating Module - Week 24 - Negative
    4
        Compulsive Eating Module - Week 24 - Positive
    0
        Compulsive Eating Module - Early Termination - Neg
    61
        Compulsive Eating Module - Early Termination - Pos
    1
        Compulsive Eating Module - Safety Follow-up - Neg
    57
        Compulsive Eating Module - Safety Follow-up - Pos
    0
        Punding Behavior - Screening - Negative
    66
        Punding Behavior - Screening - Positive
    0
        Punding Behavior - Week 2 - Negative
    60
        Punding Behavior - Week 2 - Positive
    0
        Punding Behavior - Week 6 - Negative
    44
        Punding Behavior - Week 6 - Positive
    0
        Punding Behavior - Week 12 - Negative
    22
        Punding Behavior - Week 12 - Positive
    0
        Punding Behavior - Week 24 - Negative
    4
        Punding Behavior - Week 24 - Positive
    0
        Punding Behavior - Early Termination - Negative
    62
        Punding Behavior - Early Termination - Positive
    0
        Punding Behavior - Safety Follow-up - Negative
    57
        Punding Behavior - Safety Follow-up - Positive
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    52 weeks but due to early termination subjects last visit was at Week 24.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Tozadenant
    Reporting group description
    -

    Serious adverse events
    Tozadenant
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 66 (7.58%)
         number of deaths (all causes)
    2
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Tibia fracture
         subjects affected / exposed
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Agranulocytosis
         subjects affected / exposed
    2 / 66 (3.03%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Colitis ischaemic
         subjects affected / exposed
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Gallbladder disorder
         subjects affected / exposed
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia aspiration
         subjects affected / exposed
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Abdomincal abscess
         subjects affected / exposed
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Atypical pneumonia
         subjects affected / exposed
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    Tozadenant
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    46 / 66 (69.70%)
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    2 / 66 (3.03%)
         occurrences all number
    2
    Blood glucose increased
         subjects affected / exposed
    2 / 66 (3.03%)
         occurrences all number
    2
    Blood pressure increased
         subjects affected / exposed
    2 / 66 (3.03%)
         occurrences all number
    2
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    7 / 66 (10.61%)
         occurrences all number
    7
    Contusion
         subjects affected / exposed
    2 / 66 (3.03%)
         occurrences all number
    2
    Drug administration error
         subjects affected / exposed
    2 / 66 (3.03%)
         occurrences all number
    2
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 66 (3.03%)
         occurrences all number
    2
    Orthostatis hypotension
         subjects affected / exposed
    2 / 66 (3.03%)
         occurrences all number
    2
    Nervous system disorders
    Dyskinesia
         subjects affected / exposed
    17 / 66 (25.76%)
         occurrences all number
    17
    Parkinson's disease
         subjects affected / exposed
    3 / 66 (4.55%)
         occurrences all number
    3
    Headache
         subjects affected / exposed
    2 / 66 (3.03%)
         occurrences all number
    2
    Tremor
         subjects affected / exposed
    2 / 66 (3.03%)
         occurrences all number
    2
    Blood and lymphatic system disorders
    Agranulocytosis
         subjects affected / exposed
    2 / 66 (3.03%)
         occurrences all number
    2
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    6 / 66 (9.09%)
         occurrences all number
    6
    Diarrhoea
         subjects affected / exposed
    3 / 66 (4.55%)
         occurrences all number
    3
    Abdominal pain
         subjects affected / exposed
    2 / 66 (3.03%)
         occurrences all number
    2
    Constipation
         subjects affected / exposed
    2 / 66 (3.03%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 66 (3.03%)
         occurrences all number
    2
    Psychiatric disorders
    Hallucination
         subjects affected / exposed
    3 / 66 (4.55%)
         occurrences all number
    3
    Anxiety
         subjects affected / exposed
    2 / 66 (3.03%)
         occurrences all number
    2
    Insomnia
         subjects affected / exposed
    2 / 66 (3.03%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 66 (3.03%)
         occurrences all number
    2
    Joint swelling
         subjects affected / exposed
    2 / 66 (3.03%)
         occurrences all number
    2
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 66 (6.06%)
         occurrences all number
    4
    Nasopharyngitis
         subjects affected / exposed
    3 / 66 (4.55%)
         occurrences all number
    3
    Urinary tract infection
         subjects affected / exposed
    2 / 66 (3.03%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Feb 2017
    Protocol Version 2.0 To clarify the exclusion criteria that subjects who have had DBS at least 12-months before screening visit are eligible to participate in the study. To move mMIDI assessment from baseline to the screening visit so that the site has adequate time to rule out ICD prior to subjects performing baseline patient diaries. 120 mg tablet will be blue colored not white to off-white.
    09 Oct 2017
    Protocol Version 3.0 New exclusion criteria added: Addition of lower limit of ANC at screening to avoid situation where criteria are met for both study drug withdrawal and continuation. New endpoint added: Fall questionnaire Added discontinuation requirement that needs definition of severe granulocytopenia to avoid risk that continued study drug exposure could worsen neutrophil count further. Added clarification for a scale (Non-motor Symptom Assessment Scale) to be collected in ON state. Added new table to reflect the added hematology testing. Visits added to allow for more frequent hemotology monitoring to closely monitor white blood cells and absolute neutrophil counts. Addition of lower limit of ANC at screening to avoid situation where criteria are met for both study drug withdrawal and continuation. Added a statement allowing for additional review of practice PD diaries and contact details. Clarification of scales that should be performed during patient's ON state: PDQ-39 EQ-5D-5L Non-motor Symptom Assessment Scale CG-II PGI-I

    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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