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    The EU Clinical Trials Register currently displays   43801   clinical trials with a EudraCT protocol, of which   7272   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:2020-002609-24
    Sponsor's Protocol Code Number:LESVIPREGA/20/P3-3
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-07-22
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2020-002609-24
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-Controlled, Multicenter, Phase 3 Clinical Study to Evaluate Efficacy and Safety of the Once-Daily Extended-Release Pregabalin and the Immediate-Release Pregabalin in Peripheral Neuropathic Pain
    Randomizowane, wieloośrodkowe badanie fazy III prowadzone metodą podwójnie ślepej próby z kontrolnym placebo, mające na celu ocenę skuteczności i bezpieczeństwa stosowania przyjmowanej raz na dobę pregabaliny w postaci o przedłużonym uwalnianiu oraz pregabaliny w postaci o natychmiastowym uwalnianiu w leczeniu bólu występującego w neuropatii obwodowej
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety Study of the Extended-Release Pregabalin and the Immediate-Release Pregabalin in Peripheral Neuropathic Pain
    Badanie skuteczności i bezpieczeństwa pregabaliny w postaci o przedłużonym uwalnianiu oraz pregabaliny w postaci o natychmiastowym uwalnianiu w leczeniu bólu występującego w neuropatii obwodowej
    A.4.1Sponsor's protocol code numberLESVIPREGA/20/P3-3
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNeuraxpharm Pharmaceuticals S.L.
    B.1.3.4CountrySpain
    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 supportNeuraxpharm Pharmaceuticals S.L.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNeuraxpharm Pharmaceuticals S.L.
    B.5.2Functional name of contact pointEmili González-Pérez
    B.5.3 Address:
    B.5.3.1Street AddressAvda. Barcelona, 69
    B.5.3.2Town/ citySant Joan Despí
    B.5.3.3Post code08970
    B.5.3.4CountrySpain
    B.5.4Telephone number+3493475 96 00 2258
    B.5.6E-mailegonzalez@neuraxpharm.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.2.5The 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 namePregabalin extended-release (Pregabalin XR)
    D.3.2Product code LESVIPREGA
    D.3.4Pharmaceutical form Tablet
    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 INNPregabalin
    D.3.9.1CAS number 148553-50-8
    D.3.9.2Current sponsor codeLESVIPREGA/20/P3-3
    D.3.9.3Other descriptive namePREGABALIN
    D.3.9.4EV Substance CodeSUB10023MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number165
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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 RoleComparator
    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 Lyrica®
    D.2.1.1.2Name of the Marketing Authorisation holderUpjohn EESV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 namePGB (IR) Lyrica
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Capsule
    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 INNPregabalin
    D.3.9.1CAS number 148553-50-8
    D.3.9.2Current sponsor codeLESVIPREGA/20/P3-3
    D.3.9.3Other descriptive namePREGABALIN
    D.3.9.4EV Substance CodeSUB10023MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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.2.5The 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 namePregabalin extended-release (Pregabalin XR)
    D.3.2Product code LESVIPREGA
    D.3.4Pharmaceutical form Tablet
    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 INNPregabalin
    D.3.9.1CAS number 148553-50-8
    D.3.9.2Current sponsor codeLESVIPREGA/20/P3-3
    D.3.9.3Other descriptive namePREGABALIN
    D.3.9.4EV Substance CodeSUB10023MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number330
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Peripheral neuropathic pain
    E.1.1.1Medical condition in easily understood language
    Peripheral neuropathic pain
    E.1.1.2Therapeutic area Body processes [G] - Bones and nerves physological processes [G11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10034606
    E.1.2Term Peripheral neuropathies
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To evaluate the efficacy of once-daily PGB XR for the treatment of subjects with peripheral neuropathic pain.
    E.2.2Secondary objectives of the trial
    • To assess changes in physical functioning of subjects with peripheral neuropathic pain after initiating once-daily PGB XR.
    • To assess changes in emotional functioning measures of subjects with peripheral neuropathic pain after initiating once-daily PGB XR.
    • To evaluate the global improvement of subjects with peripheral neuropathic pain after initiating once-daily PGB XR.
    • To evaluate the treatment response of subjects with peripheral neuropathic pain after initiating once-daily PGB XR.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects must be willing and capable of giving signed informed consent.
    2. Subject must be 18 to 80 years of age inclusive, at the time of signing the informed consent.
    3. Probable or definite NP diagnosis according to the IASP grading system.
    4. Diagnosis of either painful diabetic neuropathy (PDN) or PHN.
    5. Presence of chronic peripheral neuropathic pain for more than 3 months and less than 10 years prior to Screening.
    6. Subjects with weekly average NPRS pain assessment score of ≥ 4 and ≤ 9 at Baseline (Visit 1).
    7. Female subjects:
    a) A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
    i) Not a woman of childbearing potential (WOCBP).
    OR
    ii) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 3 months after the last dose of study treatment.
    8. Disease specific criteria
    a) Painful Diabetic Neuropathy: PDN subjects with diagnosis of type 1 or type 2 diabetes mellitus with painful distal symmetrical sensorimotor neuropathy of more than 3 months duration with all of the following:
    i) Neuropathic symptoms (e.g., numbness, nonpainful paresthesias or tingling, nonpainful sensory distortions or misinterpretations, etc).
    ii) Decreased distal sensation (e.g., decreased vibration, pinprick sensation, light touch, etc).
    iii) Glycosylated hemoglobin A1c (HbA1c) of ≤ 9.5%.
    iv) Stable anti-diabetic treatment for at least 3 months prior to Screening.
    v) No evidence of skin ulcers, advanced retinopathy (defined as greater than State 3 [moderate nonproliferative diabetic retinopathy]) severe nephropathy, or obstructive atherosclerotic disease resulting from their diabetes.
    b) Postherpetic Neuralgia: PHN subjects with pain persisting for more than 3 months after onset of herpes zoster rash with lesions healed.
    E.4Principal exclusion criteria
    1. Subjects with evidence of a known etiology of peripheral neuropathy other than diabetes mellitus or postherpetic infection, including but not limited to hereditary (e.g., amyloidosis, Tangier disease, Fabry’s disease, hereditary sensory autonomic neuropathy), alcohol-related neuropathy, drug-induced neuropathy (chemotherapy, antibiotics, antiretrovirals, or other neurotoxic agents), or autoimmune disease.
    2. Subjects with diagnosis of fibromyalgia.
    3. Subjects with very severe pain likely to affect self-assessment of pain due to DPN or PHN.
    4. Subjects with skin conditions likely to alter sensation.
    5. History of alcohol or substance dependence or abuse within 1 year before the study initiation.
    6. Previous failed PGB treatment due to lack of efficacy, experienced hypersensitivity, or intolerance to PGB or other α2-δ ligands.
    7. History or presence of clinically significant or unstable cardiovascular, gastrointestinal, renal, or psychiatric disease or other condition that may indicate an increased risk of study participation or interfere with interpretation of the study results.
    8. History or presence of any clinically significant abnormality in vital signs, electrocardiogram (ECG), or laboratory test results or has any medical or psychiatric condition that, in the opinion of the Investigator, may interfere with the study procedures or compromise subject safety.
    9. History of suicide attempt within 6 months prior to Screening, or a positive response to item 4 or 5 of the Columbia Suicide Severity Rating Scale (CSSRS).
    10. Episode of major depression within 6 months prior to Screening (clinically stable minor depression is not exclusionary).
    11. Pregnant or breastfeeding women.
    12. Subjects who have cognitive ability that makes it difficult to understand the nature, scope, and possible outcomes of the clinical study or who are not cooperative in the clinical study, as judged by the Investigator.
    13. Subjects with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 3 × the upper limit of normal (ULN) or bilirubin ≥ 1.5 × ULN (isolated increase of bilirubin in fasting condition, consistent with Gilbert’s syndrome, is acceptable) or clinically significant abnormalities in biochemistry and hematology at Screening.
    14. Subjects with creatinine clearance (CrCl) ≤ 60 mL/minute.
    15. Subjects with a history of Human Immunodeficiency Virus (HIV) infection, history of Hepatitis B infection within the past year, or history of Hepatitis C infection that has not been adequately treated.
    16. Subjects that have initiated a chronic therapy with analgesics ≤ 14 days before the Screening phase.
    Note: Subjects chronically using analgesics, for conditions other than NP, may continue but they should not change the pattern of use during the study.
    17. Unable or unwilling to comply with the prohibited concomitant medication restrictions as detailed in the list of excluded medication.
    18. Treatment with live attenuated vaccines (including live attenuated COVID-19 vaccines) within 2 weeks before the IMPs administration or during the study.
    19. History of COVID-19 PCR positivity within 3 months before the IMPs administration, suspected COVID-19 based on clinical presentation within 3 months before the IMPs administration, COVID 19 requiring hospitalization, or presence of long-term sequelae of COVID-19 after discussion with medical monitor.
    20. Use of capsaicin patch within 3 months prior to Screening.
    21. Pregabalin use in the last 30 days. Subjects taking PGB in the last 30 days should be washed out of PGB for at least 30 days prior to Screening Visit.
    E.5 End points
    E.5.1Primary end point(s)
    • Change in average daily pain (ADP) score on the Numeric Pain Rating Scale (NPRS) from single-blind (SB) baseline to the end of the double-blind (DB) treatment period.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Daily
    E.5.2Secondary end point(s)
    • Change in ADP score on the NPRS from DB baseline to the end of the DB treatment period.
    • Change in the NPSI measure of chronic pain from DB baseline to the end of the DB treatment period.
    • Change in the daily physical functioning according to the self-administered Brief Pain Inventory (BPI-SF) from SB baseline to the end of the DB treatment period. Change from DB baseline will be evaluated, also.
    • Change in the health-related quality of life (HRQoL) measured with the 36-item Short-Form Health Survey (SF-36) from SB baseline to the end of the DB treatment period. Change from DB baseline will be evaluated, also.
    • Change in the quality and quantity of sleep measured with the Medical Outcomes Study Sleep Scores (MOS-SS) from SB baseline to the end of the DB treatment period. Change from DB baseline will be evaluated, also.
    • Change in the overall emotional functioning assessed with the Hospital Anxiety and Depression Scale (HADS) from SB baseline to the end of the DB treatment period. Change from DB baseline will be evaluated, also.
    • Percentage of subjects reporting ≥ 30% decrease in mean pain score on the NPRS from SB baseline to the end of the DB treatment period. Percentage of responder subjects from DB baseline will be evaluated, also.
    • Percentage of subjects reporting ≥ 50% decrease in mean pain score on the NPRS from SB baseline to the end of the DB treatment period. Percentage of responder subjects from DB baseline will be evaluated, also.
    • Time to loss of therapeutic response (LTR), defined as a reduction < 30% pain response relative to SB baseline or discontinuation due to adverse event (AE) or due to lack of efficacy. Pain response relative to DB baseline will be evaluated, also.
    • Time to LTR, defined as a reduction < 50% pain response relative to SB baseline or discontinuation due to AE or due to lack of efficacy. Pain response relative to DB baseline will be evaluated, also.
    • Subject’s subjective overall health status and improvement assessed with the Patient Global Impression of Change (PGIC) at the end of the DB treatment period.
    • Subject’s overall health status and improvement assessed with the Clinician Global Impression of Change (CGIC) by the Investigator at the end of the DB treatment period.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Daily
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned16
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA47
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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
    Last visit of the last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 207
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 208
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state280
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 415
    F.4.2.2In the whole clinical trial 415
    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)
    Safety follow up will be completed at the EOS visit at week 17. To be assessed before final inclusion and randomization in the study. The completed CSSRS should be reviewed at the time of the study visit. In cases where the responses to the CSSRS indicate any concern regarding suicidal ideation or behavior, the Investigator should take appropriate action towards a psychiatric evaluation according to local standard of care.
    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 Decision2022-03-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-20
    P. End of Trial
    P.End of Trial StatusOngoing
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