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    EudraCT Number:2022-003307-16
    Sponsor's Protocol Code Number:OMT28-C0203
    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:2023-03-14
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2022-003307-16
    A.3Full title of the trial
    A Phase 2a Safety, Tolerability, and Pharmacodynamic Study of OMT-28 in PMD patients with myopathy and/or cardiomyopathy and inflammation (PMD-OPTION)
    Eine Phase-2a-Studie zur Sicherheit, Verträglichkeit und Pharmakodynamik von OMT-28 bei PMD-Patienten mit Myopathie und/oder Kardiomyopathie und Entzündung (PMD-OPTION)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study of a new drug (OMT-28) for use in patients suffering from the genetic disease PMD including muscle disease and/or Heart muscle disease and inflammation (PMD-OPTION)
    Eine klinische Studie mit einem neuen Medikament (OMT-28) zur
    Anwendung bei Patienten, die unter der genetischen Erkrankung PMD
    leiden, zusammen mit Muskelerkrankung und/oder Herzmuskelerkrankung
    und Entzündung (PMD-OPTION)
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberOMT28-C0203
    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 SponsorOMEICOS Therapeutics GmbH
    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 supportOMEICOS Therapeutics GmbH
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOMEICOS Therapeutics GmbH
    B.5.2Functional name of contact pointLuciana Summo
    B.5.3 Address:
    B.5.3.1Street AddressRobert-Rössle-Strasse 10 (Building 79)
    B.5.3.2Town/ city13125
    B.5.3.3Post codeBerlin
    B.5.4Telephone number+493094894818
    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 nameOMT-28
    D.3.2Product code OMT-28
    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 INNnot available
    D.3.9.2Current sponsor codeOMT-28
    D.3.9.3Other descriptive name2-{[(8Z)-13-[(methylcarbamoyl)formamido]-tridec-8-en-1-yl]oxy}acetic acid
    D.3.9.4EV Substance CodeSUB234699
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number24
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary Mitochondrial Disease (PMD)
    Primäre Mitochondriale Erkrankung (PMD)
    E.1.1.1Medical condition in easily understood language
    Genetic disease called "Primary Mitochondrial Disease (PMD)" with myopathy and/or cardiomyopathy and inflammation
    Genetische Erkrankung, genannt "Primäre mitochondriale Erkrankung (PMD)", mit Myopathie und/oder Kardiomyopathie und Entzündung
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To determine the responder rate of patients with a between phase difference in GDF-15 of at least 20% decrease after 12 weeks of treatment.
    - To assess safety and tolerability of OMT-28 at 24 mg
    • Bestimmung der Responder-Rate von Patienten, deren GDF-15-Wert
    zwischen den Phasen um mindestens 20 % abnimmt nach 12 Wochen
    • Bewertung der Sicherheit und Verträglichkeit von OMT-28 bei 24 mg
    E.2.2Secondary objectives of the trial
    - To determine the responder rate of patients with a between phase difference in GDF-15 of at least 20 % decrease after 24 weeks of treatment.
    - To evaluate and compare the change in GDF-15 before and after the administration of OMT-28.
    - To assess the pharmacokinetics (PK) of OMT-28 administered once daily in patients with PMD.
    • Bestimmung der Responder-Rate von Patienten, deren GDF-15-Wert
    zwischen den Phasen um mindestens 20 % abnimmt nach 24 Wochen
    • Bewertung und Vergleich der Veränderung von GDF-15 vor und nach der Verabreichung von OMT-28.
    • Bewertung der Pharmakokinetik (PK) von OMT-28 bei einmal täglicher Gabe bei Patienten mit PMD
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Any gender, age 18 to 60 years
    2. Documented mutation resulting in mitochondrial disease: mitochondrial tRNA point mutations, including m3243A>G, m8344A>G, and single mtDNA deletions
    3. Diagnosis of Cardiomyopathy defined as LV hypertrophy and/or LVEF<50% and/or late gadolinium enhancement on cardiac MRI and/or Myopathy as defined by the International Workshop: Outcome measures and clinical trial readiness in primary mitochondrial myopathies in children and adult (Mancuso et al. 2017)
    4. GDF-15 between 1,200 to 10,000 pg/mL measured at screening
    5. Ability to perform the exercise tests
    6. Willing and able to provide a signed Informed Consent, as well as written documentation in accordance with country and local privacy requirements, e.g., written data protection consent
    7. Able and willing to comply with the requirements of this study protocol
    8. Both female patients, as well as, female partners of male patients who are of child- bearing potential must be willing to not become pregnant for the complete duration of the study (30 days after the last dose of study medication).
    1. Jedes Geschlecht, Alter 18 bis 60 Jahre
    2. Dokumentierte Mutation, die zu einer mitochondrialen Erkrankung führt: mitochondriale tRNA-Punktmutationen, einschließlich m3243A>G, m8344A>G, und einzelne mtDNA-Deletionen
    3. Diagnose von Kardiomyopathie definiert als LV Hypertrophie
    und/oder LVEF<50% und/oder „spätes Gadolinium-
    Enhancement“ im kardialen MRT und/oder Myopathie gemäß
    den Definitionen des Internationalen Workshops: Outcome
    measures and clinical trial readiness in primary mitochondrial
    myopathies in children and adult (Mancuso et al. 2017)
    4. GDF-15 zwischen 1.200 ng/L und 10.000 ng/L beim Screening
    5. Fähigkeit zur Durchführung der Belastungstests
    6. Bereit und in der Lage, eine unterzeichnete Einwilligungserklärung sowie eine schriftliche Dokumentation gemäß den länderspezifischen und lokalen Datenschutzbestimmungen vorzulegen, z. B. eine schriftliche Einwilligung zum Datenschutz
    7. Bereit und in der Lage, die Anforderungen dieses Studienprotokolls zu erfüllen
    8. Sowohl weibliche Patienten als auch weibliche Partner von männlichen Patienten, die im gebärfähigen Alter sind, müssen bereit sein, während der gesamten Dauer der Studie (30 Tage nach der letzten Dosis des Studienmedikaments) nicht schwanger zu werden.
    E.4Principal exclusion criteria
    1. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
    2. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
    3. Subjects with a history of cancer in the last 5 years
    4. Hypertension defined as systolic BP >160 mmHg or diastolic BP >100 mmHg at screening
    5. Uncontrolled Diabetes mellitus according to investigator’s assessment
    6. Stroke-like episodes or seizures occurred within last 6 months
    7. Motoric abnormalities other than related to the mitochondrial disease interfering with the outcome parameters
    8. History or evidence of active tuberculosis (TB) infection, any co-disease with inflammatory condition (e.g. Inflammatory Bowel Disease (IBD) etc.)
    9. Patients with a positive hepatitis panel and/or positive immunodeficiency virus test at screening
    10. Regular use of steroid, non-steroidal anti-inflammatory drug (NSAID), or colchicine within 30 days before screening
    11. Chronic use of Metformin
    12. Use of fish oil / omega-3 fatty acid supplements within 2 weeks before screening
    13. Drinking more than 9 standard cups of alcohol per week and/or more than 3 standard cups of alcohol per occasion
    14. Positive drug and alcohol screen (including opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines)
    15. Any significant hepatic disease (defined as the presence of at least one of the following: AST, ALT, GGT, total bilirubin, or alkaline phosphatase >3x upper limit normal)
    16. Receiving any investigational therapy or any approved therapy for investigational use within 30 days or 5 half-lives prior to screening (whichever is longer)
    17. Received any vaccines (including the booster vaccination for Covid-19) within two weeks prior to Visit 1
    18. Females of childbearing potential (those who are not surgically sterilized or post- menopausal for at least 1 year) are excluded from participation in the study unless they agree to use adequate contraception as described in Appendix 11.4 of the protocol
    19. Males (including sterilized subjects) and whose female partners have child-bearing potential, must agree to use male contraception (condoms) during the period from the time of signing the informed consent form (ICF) through 30 days after the last dose of study drug. They must agree to immediately inform the investigator if his partner becomes pregnant during the study.
    20. Subjects who have previously been exposed to OMT-28, whether responder or nonresponder
    21. Any use of statins (HMG-CoA reductase inhibitors)
    22. Use of quinine, tacrolimus, mycophenolate mofetil, ciclosporin, serotine receptortype 1 agonist, penicillin G, penicillamine (d-penicillamine), nicotinic acid (niacin), colchicine, isotretinoin, and amiodarone, PPAR activators, AMPK activators, Sirtuin activators, Steroids, COX-inhibitors
    1. Schwangere, Stillende oder Personen, die nicht bereit sind, während der Teilnahme an der Studie zu verhüten
    2. Vorhandensein eines Zustands oder einer Anomalie, die nach Ansicht des Prüfers die Sicherheit des Patienten oder die Qualität der Daten gefährden würde
    3. Probanden, bei denen in den letzten 5 Jahren eine Krebserkrankung aufgetreten ist
    4. Bluthochdruck definiert als systolischer Blutdruck >160 mmHg oder diastolischer Blutdruck >100 mmHg bei der Untersuchung
    5. Unkontrollierter Diabetes mellitus nach Einschätzung des Prüfarztes
    6. Schlaganfall-ähnliche Episoden oder Krampfanfälle innerhalb der letzten 6 Monate
    7. Motorische Anomalien, die nicht mit der mitochondrialen Erkrankung zusammenhängen und die klinischen Tests beeinträchtigen
    8. Vorgeschichte oder Anzeichen einer aktiven Tuberkuloseinfektion (TB), einer Begleiterkrankung mit entzündlichen Zuständen (z.B. entzündliche Darmerkrankung (IBD) usw.)
    9. Patienten mit positivem Hepatitis-Panel und/oder positivem Immunschwächevirus-Test beim Screening
    10. Regelmäßige Einnahme von Steroiden, nicht-steroidalen Antirheumatika (NSAID) oder Colchicin innerhalb von 30 Tagen vor dem Screening
    11. Regelmäßige Einnahme von Metformin
    12. Einnahme von Fischöl/Omega-3-Fettsäure-Präparaten innerhalb von 2 Wochen for dem Screening
    13. Trinken von mehr als 9 Standardtassen Alkohol pro Woche und/oder mehr als 3 Standardtassen Alkohol pro Gelegenheit
    14. Positiver Drogen- und Alkoholtest (einschließlich Opiate, Methadon, Kokain, Amphetamine [einschließlich Ecstasy], Cannabinoide, Barbiturate, Benzodiazepine)
    15. Jede signifikante Lebererkrankung (definiert als das Vorhandensein von mindestens einem der folgenden Werte: AST, ALT, GGT, Gesamtbilirubin oder alkalische Phosphatase >3x normaler Obergrenze)
    16. Erhalt eines Prüfmedikaments oder eines zugelassenen Medikaments für Prüfzwecke innerhalb von 30 Tagen oder 5 Halbwertszeiten vor dem Screening (je nachdem, welcher Zeitraum länger ist)
    17. Erhalt von Impfstoffen (einschließlich der Auffrischungsimpfung für Covid-19) innerhalb von zwei Wochen vor Visite 1
    18. Frauen im gebärfähigen Alter (die nicht chirurgisch sterilisiert oder seit mindestens einem Jahr postmenopausal sind) sind von der Teilnahme an der Studie ausgeschlossen, es sei denn, sie verpflichten sich zu einer angemessenen Empfängnisverhütung, wie in Anhang 11.4 des Protokolls beschrieben
    19. Männer (einschließlich sterilisierter Probanden) und deren Partnerinnen im gebärfähigen Alter müssen sich verpflichten, während des Zeitraums von der Unterzeichnung der Einwilligungserklärung (ICF) bis 30 Tage nach der letzten Dosis des Studienmedikaments männliche Verhütungsmittel (Kondome) zu verwenden. Sie müssen sich verpflichten, den Prüfarzt unverzüglich zu informieren, wenn ihre Partnerin während der Studie schwanger wird.
    20. Probanden, die zuvor mit OMT-28 behandelt wurden, unabhängig davon, ob sie darauf ansprechen oder nicht
    21. Jegliche Verwendung von Statinen (HMG-CoA-Reduktase-Hemmern)
    22. Verwendung von Chinin, Tacrolimus, Mycophenolatmofetil, Ciclosporin, Serotinrezeptor-Typ 1-Agonisten, Penicillin G, Penicillamin (d-Penicillamin), Nikotinsäure (Niacin), Colchicin, Isotretinoin und Amiodaron, PPAR-Aktivatoren, AMPK-Aktivatoren, Sirtuin-Aktivatoren, Steroide, COX-Inhibitoren
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint:
    • Number of patients (responder rate) with a between phase difference in GDF-15 of at least 20% decrease after 12 weeks of treatment.
    Primary Safety Endpoints:
    • Incidence, severity, seriousness, reported causality, and duration of TEAEs, clinically significant changes in safety laboratory, vital signs, and 12-lead ECG
    Primärer Wirksamkeits-Endpunkt:
    • Anzahl der Patienten (Responder-Rate), bei denen der GDF-15-Wert
    zwischen den Phasen um mindestens 20 % gesunken ist nach 12
    Wochen Behandlung.
    Primärer Sicherheits-Endpunkt:
    • Inzidenz, Schwere, Schweregrad, berichtete Kausalität und Dauer von TEAEs, klinisch signifikante Veränderungen im Sicherheitslabor, Vitalparametern und 12-Kanal-EKG
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 1 Screening
    Visit 2 Baseline/Start of Treatment
    Visit 3
    Visit 4
    Visit 5 End of Treatment
    Visit 6 Follow-up Visit
    Studienvisite 1 Screening
    Studienvisite 2 Zustand kurz vor der Behandlung/Behandlungsbeginn
    Studienvisite 3
    Studienvisite 4
    Studienvisite 5 Behandlungsende
    Studienvisite 6 Nachsorge Visite
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints:
    • GDF-15 during evaluation phases, change in GDF-15 during evaluations phases and comparison of GDF-15 between evaluation phases.
    • Number of patients (responder rate) with a between phase difference in GDF-15 of at least 20% decrease after 24 weeks of treatment.
    Secondary Pharmacokinetic Endpoints:
    • Trough plasma concentrations (Ctrough) of OMT-28 at Visit 2 to Visit 5.
    • Plasma concentration of OMT-28 approximately at Cmax and one further timepoint after single dose (Visit 2) and at steady state (Visit 4).
    Sekundärer Wirksamkeits-Endpunkt:
    • GDF-15 während der Evaluierungs-Phasen, Veränderung von GDF-15 während der Evaluierungs-Phasen und Vergleich von GDF-15 zwischen den Evaluierungs-Phasen.
    • Anzahl der Patienten (Responder-Rate) mit einer Abnahme der GDF-15-Werte zwischen den Phasen um mindestens 20 % nach 24 Wochen Behandlung
    Sekundärer Pharmakokinetischer-Endpunkt:
    • Basale Plasma-Konzentration (Ctrough) von OMT-28 bei Visite 2 bis Visite 5.
    • Plasma-Konzentration von OMT-28 bei näherungsweise Cmax und bei einem weiteren Zeitpunkt nach Einmalgabe (Visite 2) und im Gleichgewicht (Visite 4)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visit 1 Screening
    Visit 2 Baseline/Start of Treatment
    Visit 3
    Visit 4
    Visit 5 End of Treatment
    Visit 6 Follow-up Visit
    Studienvisite 1 Screening
    Studienvisite 2 Zustand kurz vor der Behandlung/Behandlungsbeginn
    Studienvisite 3
    Studienvisite 4
    Studienvisite 5 Behandlungsende
    Studienvisite 6 Nachsorge Visite
    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 Yes
    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. 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 No
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 32
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 32
    F.4.2.2In the whole clinical trial 32
    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)
    At the end of the clinical trial, affected persons will not be allowed to receive further study medication. The continued treatment by a respective physician will be on basis of 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 Decision2023-03-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-02-06
    P. End of Trial
    P.End of Trial StatusOngoing
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