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    Summary
    EudraCT Number:2022-000054-28
    Sponsor's Protocol Code Number:OLIGOTREAT
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-01-27
    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 ConcernedGermany - BfArM
    A.2EudraCT number2022-000054-28
    A.3Full title of the trial
    Combining Clemastine and Aerobic Exercise to Treat Cognitive Dysfunction in Schizophrenia by Targeting Myelin Plasticity (OligoTreat)
    Die Behandlung der kognitiven Dysfunktion durch Verbesserung der Myelinplastizität mittels Kombination von Clemastin und aerobem Ausdauertraining bei Patienten mit einer Schizophrenie (OligoTreat)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Combining Clemastine and Aerobic Exercise to Treat Cognitive Dysfunction in Schizophrenia by Targeting Myelin Plasticity (OligoTreat)
    Die Behandlung der kognitiven Dysfunktion durch Verbesserung der Myelinplastizität mittels Kombination von Clemastin und aerobem Ausdauertraining bei Patienten mit einer Schizophrenie (OligoTreat)
    A.3.2Name or abbreviated title of the trial where available
    OligoTreat
    OligoTreat
    A.4.1Sponsor's protocol code numberOLIGOTREAT
    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 SponsorKlinikum der Universität München
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportStanley Foundation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTUM School of Medicine and Health, Münchner Studienzentrum
    B.5.2Functional name of contact pointDr. med. Christiane Blankenstein
    B.5.3 Address:
    B.5.3.1Street AddressIsmaninger Str. 22
    B.5.3.2Town/ cityMünchen
    B.5.3.3Post code81675
    B.5.3.4CountryGermany
    B.5.4Telephone number00498941406321
    B.5.5Fax number00498941406322
    B.5.6E-mailmuenchner.studienzentrum@mri.tum.de
    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.2.5The 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 nameClemastinfumarat
    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 INNClemastine fumarate
    D.3.9.1CAS number 14976-57-9
    D.3.9.4EV Substance CodeSUB01335MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10,72
    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 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
    Schizophrenia
    Schizophrenie
    E.1.1.1Medical condition in easily understood language
    Schizophrenia
    Schizophrenie
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10039626
    E.1.2Term Schizophrenia
    E.1.2System Organ Class 10037175 - Psychiatric 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 1 is the change in Global Assessment of Functioning (GAF) scores from the start of the intervention period (V1.1) to primary outcome visit after 90-93 days of treatment (V2).
    The primary objective 2 is the change in working memory performance assessed by the n-back test (2-back level, d-prime) from V1.1 to V2.
    Hauptziel 1 ist die PrimäreVerbesserung im GAF (Global Assessment of Functioning) und
    das Hauptziel 2 ist das Arbeitsgedächtnisses im n-back (2-back, hit rate) nach drei Monaten (V2 im Vergleich zu Baseline (V1.1).
    E.2.2Secondary objectives of the trial
    •Change in total PANSS scores at V2 compared to baseline
    •Change in Clinical Global Impression (CGI) rating scale at V2 compared to baseline
    •Change in remission criteria (“Andreasen Remission criteria”) status from V2 compared to baseline
    •Change in GAF and n-back scores (2-back, d-prime) from V3 compared to V2
    Veränderung der Bewertungsskala Clinical Global Impression (CGI) bei V2 im Vergleich zu
    im Vergleich zum Ausgangswert
    -Veränderung des Status der Remissionskriterien ("Andreasen Remission criteria")
    von V2 im Vergleich zum Ausgangswert
    Veränderung der GAF- und n-Rücken-Scores (2-Rücken, d-Prime) ab V3 im Vergleich
    mit V2
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Written informed consent obtained from the participant prior to performing any protocol-related procedures, including screening evaluations
    2. DSM-V diagnosis of schizophrenia or schizophrenia-spectrum disorder according to MINI interview
    3.Age between 18 and 65 years
    4.Total Positive and Negative Syndrome Scale (PANSS) score ≤ 75 at V0
    5.Stable antipsychotic treatment dose for at least one week prior to inclusion
    6.Stable CNS-active treatment substance and dose (e.g. antidepressants and mood stabilizers) for at least one week prior to inclusion
    7.Female participants with reproductive potential must have a negative beta-HCG serum pregnancy test using a pregnancy test strip as part of the screening visit
    8.Female participants with reproductive potential must have a negative serum pregnancy test within seven days prior to randomization
    9.Male participants and female participants who are not capable of bearing children or who use a method of contraception that is medically approved by the health authority of the respective country at screening
    1.Schriftliche Einverständniserklärung vor der Durchführung von protokollbezogenen Verfahren, einschließlich Screening-Untersuchungen
    2.DSM-V-Diagnose einer Schizophrenie oder Schizophrenie-Spektrum-Störung gemäß MINI-Interview
    3.Alter zwischen 18 und 65 Jahren
    4.PANSS Total Score ≤ 75 bei V0
    5.Stabile antipsychotische Behandlung seit mindestens einer Woche vor Studieneinschluss
    6.Stabile ZNS-wirksame Medikation (in Anzahl und Dosis), z. B. Antidepressiva und Stimmungsstabilisatoren) seit mindestens einer Woche vor Studieneinschluss
    7.Weibliche Teilnehmerinnen im gebärfähigen Alter müssen im Rahmen des Screenings einen negativen Serum-Schwangerschaftstest vorweisen
    8.Weibliche Teilnehmerinnen im gebärfähigen Alter müssen innerhalb von sieben Tagen vor der Randomisierung einen negativen Serumschwangerschaftstest vorweisen
    9.Männliche und weibliche Teilnehmer, die nicht gebärfähig sind oder zum Zeitpunkt des Screenings eine von der Gesundheitsbehörde des jeweiligen Landes medizinisch zugelassene Methode der Empfängnisverhütung anwenden
    E.4Principal exclusion criteria
    1.Patients who are unable to give informed consent
    2.Coercive treatment at the time of study inclusion
    3.Treatment-naïve schizophrenia defined as cumulative treatment with an antipsychotic agent lifetime for <30 days
    4.Insufficient understanding of the German language
    5.Patients with primary active (moderate or severe) substance use disorder (other than nicotine) according to MINI interview (DSM-V): patients fulfilling early (>3 months) or sustained (>12 months) remission criteria and/or with low severity of substance use disorder according to MINI are eligible for the study
    6.Known clinically relevant CNS disorder(s), such as epilepsy or history of seizures
    7.Concomitant use of any other putative remyelinating therapy as determined by investigator
    8.Co-occurrent unstable somatic condition
    9.Known porphyria
    10.Known narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, prostatic hypertrophy with urinary retention and bladder neck obstruction
    11.Current treatment with agents with strong anticholinergic properties, such as MAO-inhibitors, opioid antagonists, clozapine at the time of study inclusion
    12.Known intolerance, allergy/contraindications to one of the study drugs or any of the excipients or other agents with similar chemical properties as the study drugs (such as other arylalkylamine antihistamines)
    13.Clinically relevant liver and/or renal impairment (serum creatinine >1.5mg/dl or eGFR<30 ml/min/1.73 m2 at screening, AST or ALT > 2-times the upper limit of normal at screening)
    14.Current treatment with macrolide-antibiotics (such as erythromycin, clarithromycine) or azole-type antimycotics
    15.Clinically relevant cardiac comorbidities (i.e. Long QT-syndrome)
    16.Current hypokalaemia and/or clinically relevant hyponatraemia at screening
    17.Patient-reported hereditary galactose-intolerance and/or Lapp lactose-deficiency, lactose intolerance and/or glucose-galactose malabsorption
    18.Pregnancy or breast-feeding
    19.Concurrent enrolment in another clinical trial where the participant is receiving an IMP or participation in another clinical trial with IMP during the last 30 days before inclusion or 7 half-lives of previously used IMP, whichever is longer.
    20.For the optional MRI assessments: potential MRI contraindication(s)
    1.Nicht-einwilligungsfähige Patient*innen
    2.Zwangsbehandlung zum Zeitpunkt des Studieneinschlusses
    3.Therapienaive Schizophrenie, definiert als kumulative Behandlung mit einem Antipsychotikum während der gesamten Lebenszeit für < 30 Tage
    4.Unzureichendes Verständnis der deutschen Sprache
    5.Patienten mit primärer aktiver (moderater oder schwerer) Substanzkonsumstörung (außer Nikotin) gemäß MINI-Interview (DSM-V): Patienten, die die Kriterien für eine frühe (>3 Monate) oder anhaltende (>12 Monate) Remission erfüllen und/oder eine geringe Schwere der Substanzkonsumstörung gemäß MINI aufweisen, sind für die Studie geeignet
    6.Bekannte klinisch relevante ZNS-Störung(en) wie Epilepsie oder epileptische Anfälle in der Vorgeschichte
    7.Gleichzeitige Anwendung einer anderen mutmaßlichen Remyelinisierungstherapie nach Einschätzung des Prüfarztes
    8.Gleichzeitig bestehende instabile somatische Erkrankung
    9.Bekannte Porphyrie
    10.Bekanntes Engwinkelglaukom, stenosierendes peptisches Ulkusleiden, pyloroduodenale Obstruktion, Prostatahypertrophie mit Harnverhalt und Blasenhalsobstruktion
    11.Gegenwärtige Behandlung mit Medikamenten mit stark anticholinergen Eigenschaften, wie MAO-Hemmer, Opioid-Antagonisten, Clozapin zum Zeitpunkt des Studieneinschlusses
    12.Bekannte Unverträglichkeiten, Allergien/Kontraindikationen gegen eines der Studienpräparate oder einen der Stoffe oder andere Wirkstoffe mit ähnlichen chemischen Eigenschaften wie die Studienprüfpräparate (wie andere Arylalkylamin Antihistaminika)
    13.Klinisch relevante Leber- und/oder Nierenfunktionsstörungen (Serumkreatinin >1,5mg/dl oder eGFR<30 ml/min/1,73 m2 bei Screening, AST oder ALT > 2-fache obere Grenze der Norm bei Screening)
    14.Aktuelle Therapie mit Makrolid-Antibiotika (wie Erythromycin, Clarithromycin) oder Antimykotika vom Azol-Typ
    15.Klinisch relevante kardiale Komorbiditäten (z. B. Long-QT-Syndrom)
    16.Gegenwärtige Hypokaliämie und/oder klinisch relevante Hyponatriämie bei Screening
    17.Vom Patienten angegebene hereditäre Galaktose-Intoleranz und/oder Lapp-Laktose-Mangel, Laktose-Intoleranz und/oder Glukose-Galaktose-Malabsorption
    18.Bestehende Schwangerschaft oder Stillzeit
    19.Gleichzeitige Teilnahme an einer anderen klinischen Prüfung, bei der der Teilnehmer ein IMP erhält, oder Teilnahme an einer anderen klinischen Prüfung mit einem IMP in den letzten 30 Tagen vor dem Einschluss oder 7 Halbwertszeiten des zuvor verwendeten IMP, je nachdem, was länger ist.
    20. Für die fakultativen MRT-Untersuchungen: mögliche MRT-Kontraindikation(en)
    E.5 End points
    E.5.1Primary end point(s)
    1. Absolute change in working memory performance assessed by the n-back test (2-back, d-prime) after 90-93 days of treatment.
    2. Absolute change in GAF score after 90-93 days of treatment.
    1. Absolute Veränderung des Arbeitsgedächtnisses im n-back (2-back, hit rate) nach 90-93 Tagen (V2 im Vergleich zu Baseline (V1.1).
    2. Verbesserung im GAF (Global Assessment of Functioning) nach 90-93 Tagen Behandlung
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline (V1.1) to 90-93 days (V2).
    Baseline (V1.1) bis 90-93 Tage (V2).
    E.5.2Secondary end point(s)
    •Change in total PANSS scores at V2 compared to baseline
    •Change in Clinical Global Impression (CGI) rating scale at V2 compared to baseline
    •Change in remission criteria (“Andreasen Remission criteria”) status from V2 compared to baseline
    •Change in GAF and n-back scores (2-back, d-prime) from V3 compared to V2

    Exploratory endpoint(s):
    •Change in Calgary Depression Scale for Schizophrenia (CDSS) score at V2 compared to baseline
    •Change in World Health Organization Quality of Life Brief Version
    (WHO-QOL-BREF) at V2 compared to baseline
    •Change in verbal memory and fluency, motor speed, attention, speed of information processing, working memory, executive functions, and global cognition according to the Brief Assessment of Cognition in Schizophrenia (BACS) and change in attention span and executive functions in the Trail Making Test (TMT) A & B at V2 compared to baseline
    •Change in Physical fitness at V2 compared to baseline: Physical working capacity (PWC130: power [W] at a heart rate of 130 beats per minute, power [W] at fixed values of lactate concentrations)
    •Change in weight, waist-to-hip-ratio after 3 months compared to baseline
    •Change in Physical activity at V2 compared to baseline: Simple Physical Activity Questionnaire (SIMPAQ), actimetry.
    •Change in 3T MRI at V2 (day 90-93): structural MRI (T1-MPRAGE, T2-SPACE), DTI, resting-state MRI and ASL, all compared to baseline
    •Change in shortening of P100 latency delay on VEPs at V2 compared to baseline.
    •Change in Functional Remission of General Schizophrenia (FROGS) scale at V2 compared to baseline
    •Change in Fatigue Scale for Motor and Cognitive Functions (FSMC) at V2 compared to baseline
    •Change in Internal-External Locus of Control Scale (IE-4), Resilience (BRS), Selfefficacy (ASKU) and exercise-related selfefficacy (SSA) at V2 compared to baseline and associations to training adherence
    •Change in Exercise Motivations Inventory and Exercise Motives and Gains Inventory (EMI-2) at V2 compared to baseline and associations to training adherence
    •Associations between personality factors assessed with the BFI-10 and training adherence
    •Change in exploratory rating scales at V3 compared to V2
    Unterschiede in den Nebenwirkungen, Unterschied im Schweregrad der Symptome (PANSS total Score, CGI), der Remissionskriterien (Andreasen-Kriterien) und den Sicherheitsparametern bei V2 in Vergleich zu V1.1, sowie die Veränderung der GAF- und n-back-Scores bei V3 im Vergleich zu V2.
    Zu den explorativen Endpunkten gehören Veränderungen in anderen kognitiven Domänen, depressiven Symptomen, dem Remissionsstatus, der Lebensqualität, metabolischen Parametern (Gewicht, Hüft-Taille-Hüft-Ratio), der körperlichen Fitness, Unterschiede in persönlichkeitsbezogenen Merkmalen, motivationalen Aspekten und der Trainingsadhärenz, Veränderungen der multimodalen MRT-Parameter und Verkürzung der P100-Latenzverzögerung bei visuell evozierten Potenzialen (VEPs) in V2 im Vergleich zu Baseline (V1.1). Erhebung von Sicherheitsparametern:
    Adverse events (AEs) bis V2 und Serious Adverse Events (SAEs) bei jeder Visite (bis V3).
    Veränderungen Body-mass-index (BMI) bei V2 im Vergleich zu Baseline. Studienlabor bei Screening (V0), Baseline Visite V1.1, Visit V1.2, Visite V1.3 und Visite V2. Das Studienlabor enthält folgende Parameter: “Kleines Blutbild”, Kreatinin, Creatinkinase, ASAT, ALAT, Kalium und Natrium. Zudem bei Baseline und V2: Glucose, Lipidprofil (HDL, LDLCholesterin, Triglyzeride), Hämoglobin A1c (HbA1c).
    Veränderungen in Standardparametern des Elektrokardiogramms (EKG) bei V2 im Vergleich zu Baseline.
    E.5.2.1Timepoint(s) of evaluation of this end point
    PANSS total score and CGI: at V2 compared to V1
    GAF and nback scores: at V3 compared to V2
    PANSS total Score und CGI: bei V2 im Vergleich zu V1
    GAF- und nback-Scores: bei V3 im Vergleich zu V2
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 concerned2
    E.8.5The trial involves multiple Member States No
    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
    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 months
    E.8.9.1In the Member State concerned days
    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: 88
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state90
    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)
    After end of trial patients will continue to be treated with routine therapy, regardless if the clinical trial was finished according to protocol or ended prematurely.
    Nach Ende der klinischen Prüfung werden die Patienten unabhängig davon, ob die klinische Prüfung protokollgemäß oder vorzeitig/nicht-protokollgemäß beendet wurde, im Rahmen der Routinetherapie der jeweiligen Einrichtung weiterbehandelt.
    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 Decision2023-04-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-06-02
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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