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    Summary
    EudraCT Number:2019-002623-14
    Sponsor's Protocol Code Number:GWSP18023
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-12-19
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2019-002623-14
    A.3Full title of the trial
    A Double-blind, Randomized, Placebo-controlled, Parallel-group Trial of the Efficacy and Safety of Nabiximols Oromucosal Spray as Add-on Therapy in Patients with Spasticity Due to Multiple Sclerosis
    Dvojitě zaslepené, randomizované, placebem kontrolované klinické hodnocení s paralelní skupinou hodnotící účinnost a bezpečnost orálního spreje Nabiximols jako doplňkové léčby u pacientů se spasticitou způsobenou roztroušenou sklerózou.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the efficacy and safety of nabiximols oromucosal spray as add-on therapy in patients with muscle stiffness due to multiple sclerosis
    Studie hodnotící účinnost a bezpečnost orálního spreje Nabiximols jako doplňkové léčby u pacientů se spasticitou způsobenou roztroušenou sklerózou.
    A.4.1Sponsor's protocol code numberGWSP18023
    A.5.4Other Identifiers
    Name:INDNumber:140706
    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 SponsorGW Pharma Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportGW Pharma Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGW Pharma Ltd
    B.5.2Functional name of contact pointRegulatory Affairs Manager
    B.5.3 Address:
    B.5.3.1Street AddressSovereign House, Vision Park, Chivers Way, Histon
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB24 9BZ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441223266800
    B.5.5Fax number+441223235667
    B.5.6E-mailgwreg@gwpharm.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 Yes
    D.2.1.1.1Trade name Sativex Oromucosal Spray (non-marketed)
    D.2.1.1.2Name of the Marketing Authorisation holderGW Pharma (International) B.V.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Oromucosal spray, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOromucosal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTetrahydrocannabinol Botanical Drug Substance (THC BDS)
    D.3.9.1CAS number 1972-08-3
    D.3.9.3Other descriptive nameDELTA-9-TETRAHYDROCANNABINOL
    D.3.9.4EV Substance CodeSUB27785
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number27
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCannabidiol Botanical Drug Substance (CBD BDS)
    D.3.9.1CAS number 13956-29-1
    D.3.9.3Other descriptive nameCANNABIDIOL
    D.3.9.4EV Substance CodeSUB26600
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product Yes
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeBotanical Drug Substances (BDSs)
    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 placeboOromucosal spray, solution
    D.8.4Route of administration of the placeboOromucosal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Symptomatic relief of spasticity in Multiple Sclerosis
    E.1.1.1Medical condition in easily understood language
    Treatment of muscle spasm in Multiple Sclerosis
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10028245
    E.1.2Term Multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10028335
    E.1.2Term Muscle spasticity
    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
    The primary objective is to establish the efficacy of nabiximols relative to placebo in reducing spasm count as part of the presentation of spasticity when used as adjunctive therapy in patients with multiple sclerosis (MS) who have not achieved adequate relief from other antispasticity agents.
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    The Secondary objectives are:
    - To evaluate the effect of nabiximols relative to placebo using the
    following patient-reported outcome measure of spasticity:
    . The MS Spasticity Scale (MSSS-88) total score
    - To evaluate the pharmacokinetics (PK) of nabiximols
    - To evaluate the safety and tolerability of nabiximols
    The Exploratory objectives are:
    - To evaluate the effect of nabiximols relative to placebo using the
    following patient-reported outcome measures and clinician-administered
    assessments of spasticity:
    . The 8 MS Spasticity Scale (MSSS-88) subscale scores
    . The 11-point NRS for spasm severity
    . The 11-point NRS for spasticity
    - To evaluate the effect of nabiximols relative to placebo on health
    related
    quality of life, as reflected by the 36-Item Short Form Health
    Survey
    - To evaluate the effect of nabiximols relative to placebo on functional
    outcome as reflected by walking ability using the T25FW test
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Screening (Visit 1)

    For inclusion in the trial, patient must fulfill ALL of the following criteria:
    - Male or female aged 18 years or above.
    - Willing and able to give informed consent for participation in the trial
    - Willing and able (in the investigator’s opinion) to comply with all trial requirement (With the exception of the T25FW test, if the patient is non-ambulatory)
    - Has had a diagnosis with any disease subtype of MS, by revised 2017 McDonald criteria, for at least 12 months prior to Visit 1 and is expected to remain stable for the duration of the trial.
    - Has had treatment with at least 1 different optimized oral MS antispasticity therapies prior to Visit 1 that must include at least oral baclofen or oral tizanidine (monotherapy or combination therapy).
    - Currently receiving optimized treatment with at least 1 oral antispasticity medication (baclofen, tizanidine or dantrolene) and has been stable for at least 30 days prior to Visit 1. Despite optimization, the patient does not have adequate relief of spasticity and signs and symptoms, including muscle spasms. Optimization of antispasticity medications is defined as having reached the most efficacious and best tolerated dose according to the relevant
    local prescribing information. The patient must be willing to maintain the same antispasticity medication and not plan to initiate a new course of physiotherapy for the duration of the trial.
    - If currently receiving an MS disease-modifying therapy, it must be at a stable dose for at least 3 months prior to Visit 1 and is expected to remain stable for the duration of the trial.
    -If currently receiving dalfampridine or fampridine, it must be at a stable dose for at least 3 months prior to Visit 1 and is expected to remain stable for the duration of the trial.
    - Willing to allow the responsible authorities to be notified of participation in the trial, if mandated by local law.
    - Willing to allow his or her primary care practitioner (if he or she has one) and/or treating neurologist (if he or she has one) to be notified of participation in the trial, if the primary care practitioner/treating neurologist is different than the investigator.

    Additional Inclusion Criteria at Randomization (Visit 2)

    The patient is eligible for randomization in the trial if, in addition to
    continuing to meet the Screening (Visit 1) inclusion criteria, they also
    meet ALL of the following criteria during the first 28-days of the baseline
    period (Note: patients are expected to start completing their electronic
    diary in the evening of their screening visit):
    - In the opinion of the investigator the patient is able to interpret and
    report spasm count data accurately
    - Completed their electronic diary for at least 25 of the first 28 days of
    the baseline period
    - Has an average daily spasm count of ≥ 4 during the first 28 days of the
    baseline period, as recorded by the patient.
    - Has no more than 35 spasms on any single day of the first 28 days of
    the baseline period, as recorded by the patient
    - Does not have > 7 consecutive days without experiencing any spasm
    during the first 28 days of the baseline period.
    If, for any reason, the patient is unable to attend the site for
    randomization within the visit window, the site should contact the
    Medical Monitor or the sponsor to discuss. In addition to meeting the
    Screening (Visit 1) inclusion criteria and additional inclusion criteria
    above (apart from last bullet point), any patient with more than 28 days
    between Visit 1 and Visit 2 would need to meet ALL of the following
    criteria prior to randomization:
    - Completed their electronic diary for at least 85% of days between Visit 1 and Visit 2
    - Has an average daily spasm count of ≥ 4 between Visit 1 and Visit 2
    (randomization), as recorded by the patient
    - Has no more than 35 spasms on any single day between Visit 1 and
    Visit 2, as recorded by the patient
    - Does not have > 7 consecutive days without experiencing any spasm
    between Visit 1 and Visit 2.
    E.4Principal exclusion criteria
    Previously participated in a clinical trial of nabiximols or has had a poor previous response or intolerance to nabiximols or other cannabinoid-containing products used for therapeutic purposes
    - Any concomitant disease or disorder that has spasticity-like symptoms or that may influence the patient’s level of spasticity
    - Medical history suggests that relapse/remission is likely to occur during the trial which is expected to influence the patient’s spasticity
    - Has had a relapse of MS within the 60 days prior to Visit 1
    - Has taken cannabis, or a cannabis-derived product for medicinal or recreational use within the 30 days prior to screening or a positive blood drug test for THC at screening
    - Is unwilling to abstain from use of cannabis or a cannabis-derived product for medicinal or recreational purposes for the duration of the trial
    - Currently using botulinum toxin injection for the relief of spasticity
    - Is unwilling to abstain from the use of botulinum toxin injection for the relief of spasticity for the duration of the trial
    - Currently taking antipsychotic medication
    - Currently taking benzodiazepines unless the doses and dosing regimen have been stable for at least 30 days prior to Visit 1
    - Has any known or suspected hypersensitivity to cannabinoids or any of the excipients of the IMP
    - Has experienced myocardial infarction or clinically significant cardiac dysfunction within the 12 months prior to Visit 1 or has a cardiac disorder that would put the patient at risk of a clinically significant arrhythmia or myocardial infarction
    - Has a diastolic blood pressure of < 50 mmHg or > 105 mmHg or systolic blood pressure < 90 mmHg or > 150 mmHg, or a postural drop in the systolic blood pressure of > or = 20 mmHg or in diastolic blood pressure of > or = 10 mmHg at Visit 1
    - Has clinically significant impaired renal function at Visit 1 as evidenced by an estimated creatinine clearance lower than 50 mL/min
    - Has moderately impaired hepatic function at Visit 1 defined as serum alanine aminotransferase or aspartate aminotransferase >2 × upper limit of normal
    - Male and fertile unless willing to ensure that he uses male contraception or remains sexually abstinent during the trial and for 3 months thereafter
    - Female and of childbearing potential unless willing to ensure that she uses a highly effective method of birth control during the trial and for 3 months thereafter. Patients using combined hormonal methods or a progestogen-only pill or injection or implant should use an additional barrier method such as a condom or diaphragm during the trial and for 3 months thereafter
    - Female and pregnant, lactating, or planning pregnancy during the course of the trial or within 3 months thereafter
    - Received an IMP within the 30 days prior to Visit 1
    - Has any other clinically significant disease or disorder that may put the patient, other patients, or site staff at risk because of participation in the trial, influence the interpretation of trial results, or may affect the patient’s ability to take part in the trial
    - Has any abnormalities identified following a physical examination, clinical laboratory, serology, or other applicable screen procedures that would jeopardize the safety of the patient or the conduct of the study if he or she took part in the trial
    - Has any history of suicidal behavior in the 5 years prior to Visit 1 or a suicidal ideation score of 3, 4, or 5 on the C-SSRS in the month prior to Visit 1
    - Has a history of severe psychiatric disorder that may be exacerbated by the use of a cannabinoid-containing product
    - Has donated blood during the 3 months prior to Visit 1 and is unwilling to abstain from donation of blood during the trial
    - Has been previously randomized into this trial
    - Has any known or suspected history of alcohol or substance use disorder within 1 year prior to Visit 1
    - Currently using an illicit drug or current nonprescribed use of any prescription drug. A positive drug test at Visits 1 or 2 for a prescribed medication is not exclusionary at the investigator’s
    discretion. A positive drug test at Visit 1 or predose at Visit 2 for illicit drugs may be repeated locally at the investigator’s discretion
    - Has any planned clinical interventions or intends to change any or all medications that may have an effect on spasticity or MS during the trial
    - Currently taking drugs that are solely metabolized by UGT1A9/UGT2B7
    - Currently taking strong CYP3A4 inducers
    - There is an expectation that the participant will require a new course of treatment with strong CYP3A4 inhibitors during the study duration
    - Patients who receive a positive coronavirus disease 2019 antigen test result before randomization may be screen failed, at the discretion of the investigator
    - Individuals who do not meet the criteria for participation in this trial (screen failure) can be rescreened once, at the discretion of the investigator or designee, with sponsor approval.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is change from baseline in the average daily spasm count (from Days 57 to 84 compared to the average daily spasm count for the baseline period).
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Days 57 to 84 and for baseline period.
    E.5.2Secondary end point(s)
    The secondary endpoints are change in MS Spasticity Scale (MSSS-88) total score, safety, tolerability, and pharmacokinetics (PK).


    Key secondary endpoint:
    Efficacy:
    - Change from baseline in the spasm subscale score of the MSSS-88 at Visit 6.

    Pharmacokinetics:
    - Plasma concentrations for THC and its relevant metabolites (11-hydroxy-Δ9-tetrahydrocannabinol [11-OH-THC] and 11-nor-9-carboxy-Δ9-tetrahydrocannabinol [11-COOH-THC]) and CBD and its relevant metabolites (7-hydroxy-cannabidiol [7-OH-CBD] and 7-carboxy-cannabidiol [7-COOH-CBD]) at Visits 2 (predose), 3, 4, 5, and 6.

    Safety:
    - Frequency of treatment-emergent adverse events (AEs).
    - Change from baseline to each assessment timepoint by treatment arm for the following:
    . Clinical laboratory tests.
    . Vital signs.
    - 12-lead electrocardiograms (ECGs).
    . Columbia-Suicide Severity Rating Scale (C-SSRS) at screening, and at each subsequent timepoint with reference to the last assessment (since last visit)

    Exploratory Endpoint(s):
    Efficacy:
    - Change from baseline in the 8 subscale scores of the MSSS-88 at Visit 6
    - Change from baseline in average daily 11 point NRS spasm severity
    score to Days 57 to 84
    - Change from the last 7 days of baseline in average daily 11-point NRS
    spasticity score to Days 78 to 84
    - Change from baseline in the SF-36 total score at Visit 6 (Day 85)
    - Change from baseline in Timed 25-Foot Walk (T25FW) test at Visit 6
    (Day 85).
    E.5.2.1Timepoint(s) of evaluation of this end point
    At Day 1 and Day 85, and during the 85 days of the double-blind treatment period for pharmacokinetics and safety above listed outcomes.
    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 Yes
    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 Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 trial2
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    Poland
    Romania
    United Kingdom
    Czechia
    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 patient last visit or last contact, whichever occurs last.
    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 months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    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: 446
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 230
    F.4.2.2In the whole clinical trial 446
    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)
    Standard of care (IMP will not be available for subjects after the end of the trial).
    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 Decision2020-03-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-02-27
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