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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
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    The EU Clinical Trials Register currently displays   43216   clinical trials with a EudraCT protocol, of which   7153   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).


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    Summary
    EudraCT Number:2017-002541-29
    Sponsor's Protocol Code Number:PVO-1A-301
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-01-26
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-002541-29
    A.3Full title of the trial
    A Phase 3, Efficacy and Safety Study of Oral Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP)
    Studio di fase 3 sull¿efficacia e sicurezza di palovarotene orale per il trattamento della Fibrodisplasia Ossificante Progressiva (FOP)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to evaluate the Efficacy and Safety of Oral Palovarotene as a treatment for Fibrodysplasia Ossificans Progressiva (FOP)
    Sperimentazione clinica per valutare l¿efficacia e la sicurezza di palovarotene orale come trattamento per la fibrodisplasia ossificante progressiva (FOP)
    A.3.2Name or abbreviated title of the trial where available
    MOVE Trial
    Sperimentazione MOVE
    A.4.1Sponsor's protocol code numberPVO-1A-301
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN00000000
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00000000
    A.5.3WHO Universal Trial Reference Number (UTRN)U0000-0000-0000
    A.5.4Other Identifiers
    Name:00000000000000000000Number:00000000000000000000
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/121/2018
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCLEMENTIA PHARMACEUTICALS INC.
    B.1.3.4CountryCanada
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportClementia Pharmaceuticals Inc
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClementia Pharmaceuticals Inc.
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street Address1000, De La Gauchetière, Suite 1200
    B.5.3.2Town/ cityMontreal, Quebec
    B.5.3.3Post codeH3Z2Y5
    B.5.3.4CountryCanada
    B.5.4Telephone number0015142283630
    B.5.5Fax number0018889660135
    B.5.6E-mailclinicaltrials@clementiapharma.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.1.1.1Trade name not applicable
    D.2.1.1.2Name of the Marketing Authorisation holdernot applicable
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/14/1368
    D.3 Description of the IMP
    D.3.1Product namePALOVAROTENE
    D.3.2Product code not assigned
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPalovarotene
    D.3.9.1CAS number 410528-02-8
    D.3.9.2Current sponsor codenot assigned
    D.3.9.3Other descriptive namePALOVAROTENE
    D.3.9.4EV Substance CodeSUB75998
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.1.1.1Trade name not applicable
    D.2.1.1.2Name of the Marketing Authorisation holdernot applicable
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/14/1368
    D.3 Description of the IMP
    D.3.1Product namePALOVAROTENE 1.5 mg
    D.3.2Product code [not applicable]
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPALOVAROTENE
    D.3.9.1CAS number 410528-02-8
    D.3.9.2Current sponsor codenot assigned
    D.3.9.3Other descriptive namePalovarotene
    D.3.9.4EV Substance CodeSUB75998
    D.3.10 Strength
    D.3.10.1Concentration unit Bq/µg becquerel(s)/microgram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.1.1.1Trade name not applicable
    D.2.1.1.2Name of the Marketing Authorisation holdernot applicable
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/14/1368
    D.3 Description of the IMP
    D.3.1Product namePALOVAROTENE-2 mg
    D.3.2Product code [not assigned]
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPALOVAROTENE
    D.3.9.1CAS number 410528-02-8
    D.3.9.2Current sponsor codenot assigned
    D.3.9.3Other descriptive namePalovarotene
    D.3.9.4EV Substance CodeSUB75998
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.1.1.1Trade name not applicable
    D.2.1.1.2Name of the Marketing Authorisation holdernot applicable
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/14/1368
    D.3 Description of the IMP
    D.3.1Product namePALOVAROTENE
    D.3.2Product code [not applicable]
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPALOVAROTENE
    D.3.9.1CAS number 410528-02-8
    D.3.9.2Current sponsor codenot applicable
    D.3.9.3Other descriptive namepalovarotene
    D.3.9.4EV Substance CodeSUB75998
    D.3.10 Strength
    D.3.10.1Concentration unit Bq/µg becquerel(s)/microgram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 5
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.1.1.1Trade name not applicable
    D.2.1.1.2Name of the Marketing Authorisation holdernot applicable
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/14/1368
    D.3 Description of the IMP
    D.3.1Product namePALOVAROTENE-3 mg
    D.3.2Product code [not applicable]
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPALOVAROTENE
    D.3.9.1CAS number 410528-02-8
    D.3.9.2Current sponsor codenot applicable
    D.3.9.3Other descriptive namePalovarotene
    D.3.9.4EV Substance CodeSUB75998
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 6
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.1.1.1Trade name not applicable
    D.2.1.1.2Name of the Marketing Authorisation holdernot applicable
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/14/1368
    D.3 Description of the IMP
    D.3.1Product namePALOVAROTENE-4 mg
    D.3.2Product code [not applicable]
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPALOVAROTENE
    D.3.9.1CAS number 410528-02-8
    D.3.9.2Current sponsor codenot applicable
    D.3.9.3Other descriptive namePALOVAROTENE
    D.3.9.4EV Substance CodeSUB75998
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 7
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.1.1.1Trade name not applicable
    D.2.1.1.2Name of the Marketing Authorisation holdernot applicable
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/14/1368
    D.3 Description of the IMP
    D.3.1Product namePALOVAROTENE-5mg
    D.3.2Product code [not applicable]
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPALOVAROTENE
    D.3.9.1CAS number 410528-02-8
    D.3.9.2Current sponsor codenot applicable
    D.3.9.3Other descriptive namePALOVAROTENE
    D.3.9.4EV Substance CodeSUB75998
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 8
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.1.1.1Trade name not applicable
    D.2.1.1.2Name of the Marketing Authorisation holdernot applicable
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/14/1368
    D.3 Description of the IMP
    D.3.1Product namePALOVAROTENE-10 mg
    D.3.2Product code [not applicable]
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPALOVAROTENE
    D.3.9.1CAS number 410528-02-8
    D.3.9.2Current sponsor codenot applicable
    D.3.9.3Other descriptive namePalovarotene
    D.3.9.4EV Substance CodeSUB75998
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 9
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name EMLA - 2.5% + 2.5% CREMA TUBO 30 G
    D.2.1.1.2Name of the Marketing Authorisation holderASTRAZENECA S.P.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameEMLA
    D.3.2Product code [not applicable]
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLIDOCAINA
    D.3.9.1CAS number 137-58-6
    D.3.9.2Current sponsor codenot applicable
    D.3.9.3Other descriptive nameLidocaine
    D.3.9.4EV Substance CodeSUB178322
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPRILOCAINA
    D.3.9.1CAS number 721-50-6
    D.3.9.2Current sponsor codenot applicable
    D.3.9.3Other descriptive namePrilocaina
    D.3.9.4EV Substance CodeSUB10041MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/ml gram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 10
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name IDROCORTISONE ACETATO DYNACREN - 1% CREMA 1 TUBO DA 30 G
    D.2.1.1.2Name of the Marketing Authorisation holderDYNACREN LABORATORIO FARMACEUTICO DEL DOTT.A.FRANCIONI E DI M.GEROSA S.R.L.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameIDROCORTISONE ACETATO DYNACREN 1% CREMA.
    D.3.2Product code [not applicable]
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIDROCORTISONE ACETATO
    D.3.9.1CAS number 50-03-3
    D.3.9.2Current sponsor codenot applicable
    D.3.9.3Other descriptive nameIDROCORTISONE ACETATO
    D.3.9.4EV Substance CodeSUB02562MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Fibrodysplasia Ossificans Progressiva (FOP)
    Fibrodisplasia ossificante progressiva (FOP)
    E.1.1.1Medical condition in easily understood language
    FOP is a rare, severely disabling disease characterized by heterotopic ossification in muscles, tendons, and ligaments often associated with painful and recurrent episodes of soft tissue swelling.
    FOP rara malattia invalidante caratterizzata da ossificazione eterotopica a livello di muscoli, tendini e legamenti, associata a dolorosi episodi ricorrenti di gonfiore a carico dei tes molli.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10068715
    E.1.2Term Fibrodysplasia ossificans progressiva
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    ¿ To evaluate the efficacy of palovarotene in decreasing heterotopic ossification (HO) in adult and pediatric subjects with FOP as assessed by low-dose, whole body computed tomography (WBCT), excluding head, as compared to untreated subjects from Clementia¿s FOP natural history study over 24 months.
    ¿ To evaluate the safety of palovarotene in adult and pediatric subjects with FOP.
    ¿ Valutare l¿efficacia di palovarotene nel ridurre l¿ossificazione eterotopica (HO) in soggetti adulti e pediatrici con FOP valutata mediante tomografia computerizzata dell¿intero corpo (WBCT) a basse dosi, esclusa la testa, rispetto ai soggetti non trattati di uno studio di storia naturale della FOP sponsorizzato da Clementia nell’arco di 24 mesi.
    ¿ Valutare la sicurezza di palovarotene in soggetti adulti e pediatrici con FOP.
    E.2.2Secondary objectives of the trial
    - To evaluate the effect of palovarotene on flare-up rate and proportion of subjects reporting at least one flare-up.
    - To evaluate the effect of palovarotene on range of motion (ROM) as assessed by the Cumulative Analogue Joint Involvement Scale for FOP (CAJIS).
    - To evaluate the effect of palovarotene on physical function using age appropriate forms of the FOP Physical Function Questionnaire (FOP PFQ).
    - To evaluate the effect of palovarotene on physical and mental health using age-appropriate forms of the Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale.
    - To evaluate the pharmacokinetics of palovarotene.
    Secondary Objective (Part B)
    - To continue to provide palovarotene to adult and pediatric subjects with FOP and to monitor longer-term safety.
    - Valutare l¿effetto di palovarotene sul tasso di riacutizzazioni e sulla percentuale di soggetti che riportano almeno una riacutizzazione.
    - Valutare l¿effetto di palovarotene sul raggio di movimento (ROM) valutato mediante la Scala analogica cumulativa del coinvolgimento articolare (CAJIS) per la FOP.
    - Valutare l¿effetto di palovarotene sulla funzione fisica utilizzando moduli del Questionario sulla funzione fisica nella FOP (FOP-PFQ) adeguati all¿et¿.
    - Valutare l¿effetto di palovarotene sulla salute fisica e mentale utilizzando moduli della Scala sulla salute globale del Sistema informativo di misurazione degli esiti riferiti dal paziente (PROMIS) adeguati all¿et¿.
    - Valutare la farmacocinetica di palovarotene.
    Obiettivo secondario (Parte B)
    • Continuare a fornire palovarotene a soggetti adulti e pediatrici con FOP e a monitorare la sicurezza a lungo termine.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following criteria to be eligible for enrollment: 1. Written, signed, and dated informed subject/parent consent; and for subjects who are minors, age-appropriate assent (performed according to local regulations).
    2. Male or female at least 4 years of age. 3. Previous participation in the NHS; or clinically diagnosed with FOP, with the R206H ACVR1 mutationor other FOP variants reported to be
    associated with progressive HO (who have not previously participated in
    any Clementia sponsored study); or participants in Study PVO 1A 202 or
    Study PVO-1A-204 who cannot currently receive the chronic/flare-up
    regimen due to country of residence or those traveling long distances to participate in the Phase 2 trial.
    4. No flare-up symptoms within the past 4 weeks, including at the time of enrollment.
    5. Females of child-bearing potential must have a negative blood or urine pregnancy test (with sensitivity of at least 50 mIU/mL) prior to administration of palovarotene. Male and FOCBP subjects must agree to remain abstinent from heterosexual sex during treatment and for 1 month after treatment or, if sexually active, to use two highly effective methods of birth control during and for 1 month after treatment. Additionally, sexually active FOCBP subjects must already be using two highly effective methods of birth control 1 month before treatment is to start. Specific risk of the use of retinoids during pregnancy, and the agreement to remain abstinent or use two highly effective methods of birth control will be clearly defined in the informed consent and the subject or legally authorized representatives (eg, parents, caregivers, or legal guardians) must specifically sign this section.
    6. Must be accessible for treatment and follow-up, and be able to undergo all study procedures. Subjects living at distant locations from the investigational site must be able and willing to travel to a site for the initial and all on-site follow-up visits. Subjects must be able to undergo low-dose, WBCT (excluding head)without sedation
    1. Consenso informato del soggetto/genitore scritto, firmato e datato e, per i minori, assenso adeguato all’età (rilasciato secondo le normative locali). 2. Soggetti di sesso maschile o femminile di almeno 4 anni di età.
    3. Precedente partecipazione all’NHS o Diagnosi clinica di FOP, con la mutazione R206H ACVR1 o diagnosi clinica di FOP, con la mutazione R206H ACVR1 o altre varianti di FOP segnalate come associate a HO progressiva (che non hanno partecipato in precedenza ad alcuno studio sponsorizzato da Clementia); o partecipanti allo studio PVO-1A-202 o allo studio PVO-1A-204 che attualmente non possono ricevere il regime di trattamento cronico/basato sulle riacutizzazioni a causa del Paese di residenza o coloro i quali percorrono distanze considerevoli per partecipare alla Sperimentazione di Fase 2. 4. Nessun sintomo di riacutizzazione nelle ultime 4 settimane, compreso il momento dell’arruolamento.
    5. Le donne in età fertile devono risultare negative al test di gravidanza sulle urine o sul sangue (con sensibilità di almeno 50 mUI/ml) prima della somministrazione di palovarotene. Le donne e i soggetti FOCBP devono acconsentire a praticare l’astinenza da rapporti eterosessuali durante il trattamento e per 1 mese dopo il trattamento oppure, se sessualmente attive, ad utilizzare due metodi contraccettivi altamente efficaci durante il trattamento e per 1 mese dopo lo stesso. Inoltre, i soggetti FOCBP sessualmente attivi devono già utilizzare due metodi contraccettivi altamente efficaci 1 mese prima dell’inizio del trattamento. Il rischio specifico dell’uso di retinoidi durante la gravidanza e il consenso a praticare l’astinenza o all’uso di due metodi contraccettivi altamente efficaci saranno definiti in maniera chiara nel consenso informato e il soggetto o rappresentante legale (es. genitori, la persona che se ne prenderà cura o tutori legali) deve firmare specificatamente questa sezione.
    6. Il soggetto deve essere disponibile a ricevere il trattamento e il follow-up e in grado di sottoporsi a tutte le procedure dello studio. I soggetti che vivono in luoghi distanti dal centro sperimentale devono essere in grado di e disposti a viaggiare verso il centro per le visite iniziali e tutte le visite di follow-up presso il centro. I soggetti devono essere in grado di sottoporsi alla WBCT a basse dosi (esclusa la testa).senza sedazione
    E.4Principal exclusion criteria
    1. Weight <10 kg. 2. If currently using vitamin A or beta carotene, multivitamins containing vitamin A or beta carotene, or herbal preparations, fish oil, and unable or unwilling to discontinue use of these products during palovarotene treatment.
    3. Exposure to synthetic oral retinoids other than palovarotene within 4 weeks prior to screening.
    4. Concurrent treatment with tetracycline or any tetracycline derivatives due to the potential increased risk of pseudotumor cerebri.
    5. History of allergy or hypersensitivity to retinoids, gelatin or lactose (note that lactose intolerance is not exclusionary).
    6. Concomitant medications that are strong inhibitors or inducers of cytochrome P450 (CYP450) 3A4 activity; or kinase inhibitors such as imatinib (see Section 5.2.1).
    7. Amylase or lipase >2x above the upper limit of normal (ULN) or with a history of chronic pancreatitis.
    8. Elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5x ULN.
    9. Fasting triglycerides >400 mg/dL with or without therapy.
    10. Female subjects who are breastfeeding.
    11. Subjects with uncontrolled cardiovascular, hepatic, pulmonary, gastrointestinal, endocrine, metabolic, ophthalmologic, immunologic, psychiatric, or other significant disease.
    12. Subjects experiencing suicidal ideation (type 4 or 5) or any suicidal behavior within the past month as defined by the Columbia-Suicide Severity Rating Scale (C-SSRS).
    13. Simultaneous participation in another investigational clinical research study (other than palovarotene studies) within 4 weeks prior to Screening; or within five half-lives of the agent, whichever is longer.
    14. Any reason that, in the opinion of the Investigator, would lead to the inability of the subject and/or family to comply with the protocol
    1. Peso <10 kg. 2. Uso corrente di vitamina A o beta carotene, multivitamine contenenti vitamina A o beta carotene o preparazioni erboristiche, olio di pesce e incapacità o riluttanza a interrompere l’uso di questi prodotti durante il trattamento con palovarotene.
    3. Esposizione a retinoidi orali sintetici diversi da palovarotene nelle 4 settimane precedenti lo screening. 4. Trattamento concomitante con tetraciclina o derivati della tetraciclina a causa del potenziale aumento del rischio di pseudotumor cerebri.
    5. Anamnesi di allergia o ipersensibilità a retinoidi, gelatina o lattosio (si noti che l’intolleranza al lattosio non determina l’esclusione).
    6. Farmaci concomitanti che agiscono da forti inibitori o induttori dell’attività della subunità 3A4 del citocromo P450 (CYP450), oppure inibitori delle chinasi come imatinib (si veda la Sezione 5.2.1).
    7. Amilasi o lipasi >2 volte il limite superiore della norma (ULN) o con un’anamnesi di pancreatite cronica.
    8. Valori elevati di aspartato aminotransferasi (AST) o alanina aminotransferasi (ALT) >2,5 x ULN.
    9. Trigliceridi a digiuno >400 mg/dl con o senza terapia.10. Soggetti di sesso femminile che allattano al seno.11. Soggetti con malattia cardiovascolare, epatica, polmonare, gastrointestinale, endocrina, metabolica, oftalmica, immunologica, psichiatrica non controllata o altra malattia significativa.
    12. Soggetti che manifestano ideazione suicidaria (di tipo 4 o 5) o qualsiasi comportamento suicidario nell’ultimo mese, secondo quanto definito dalla Scala della Columbia University per la valutazione della gravità del rischio di suicidio (C-SSRS).
    13. Partecipazione simultanea ad un altro studio interventivo di ricerca clinica interventivo (diverso dagli studi su palovarotene)nelle 4 settimane precedenti lo screening o nelle cinque emivite dell’agente sperimentale, a seconda di quale evento duri più a lungo.
    14. Qualsiasi motivo che, nell’opinione dello sperimentatore, comporterebbe l’incapacità del soggetto e/o della famiglia di attenersi al protocollo
    E.5 End points
    E.5.1Primary end point(s)
    The annualized change in new HO volume as assessed by low-dose, WBCT (excluding head) compared to untreated subjects from the NHS over 24 months.
    Variazione nell’anno nel volume di nuova HO valutata mediante WBCT a basse dosi (esclusa la testa) rispetto ai soggetti non trattati dell’NHS nell'arco di 24 mesi.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 6, 12, 18 and 24 months (final analysis). It will also being evaluated in supportive analysis at 36 and 48 months.
    Mese 6, 12, 18 e 24 mesi (analisi finale). Sarà inoltre valutato in analisi di supporto a 36 e 48 mesi.
    E.5.2Secondary end point(s)
    1. The proportion of subjects with any new HO.
    2. The change from baseline in the number of body regions with new HO.
    3. The proportion of subjects reporting flare-ups.
    4. The flare-up rate per subject-month exposure.
    1. Percentuale di soggetti con qualsiasi nuova HO.
    2. Variazione rispetto al basale nel numero di regioni corporee con nuova HO.
    3. Percentuale di soggetti che riportano riacutizzazioni.
    4. Tasso di riacutizzazioni per soggetto-mese di esposizione.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Month 6, 12, 18 and 24 months (final analysis). It will also being evaluated in supportive analysis at 36 and 48 months.
    Mese 6, 12, 18 e 24 mesi (analisi finale). Sarà inoltre valutato in analisi di supporto a 36 e 48 mesi.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Lo studio ha un controllo esterno (studio NHS-soggetti non trattati)
    The trial has en external control (NHS study - untreated subjects)
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Lo studio ha un controllo esterno (studio NHS-soggetti non trattati)
    The trial has en external control (NHS study - untreated subjects)
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Brazil
    Canada
    France
    Germany
    Italy
    Japan
    Korea, Democratic People's Republic of
    Korea, Republic of
    Netherlands
    Russian Federation
    South Africa
    Spain
    Sweden
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 45
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 35
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 27
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    subjects of study are male of female at least 4 years old
    i soggetti di studio sono di sesso maschile e femminile di almeno 4 anni
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 107
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    risk/benefit profile based on the emerging Phase 3 data warrants it, subjects will be offered to continue treatment until commercial availability of the product in a subject's country of residence.
    profilo rischi/benefici basato sui dati di fase 3 emergenti lo giustifica, i soggetti avranno la possibilit¿ di continuare il trattamento fino alla disponibilit¿ commerciale del prodotto nel proprio paese di residenza.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-03-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-12
    P. End of Trial
    P.End of Trial StatusOngoing
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