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    Summary
    EudraCT Number:2021-003677-66
    Sponsor's Protocol Code Number:RESTORE
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-12-16
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-003677-66
    A.3Full title of the trial
    Clemastine fumarate as remyelinating treatment in internuclear ophthalmoparesis and multiple sclerosis
    Clemastine fumaraat als remyeliniserende therapie in internucleaire oftalmoplegie en multiple sclerose
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clemastine fumarate as a treament for eye movement disorders in patients with multiple sclerosis
    Clemastine fumaraat als behandeling voor een stoornis in de oogbewegingen bij patiënten met multiple sclerose
    A.3.2Name or abbreviated title of the trial where available
    RESTORE
    A.4.1Sponsor's protocol code numberRESTORE
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05338450
    A.5.4Other Identifiers
    Name:ToetsingOnlineNumber:NL78363.029.21
    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 SponsorAmsterdam University Medical Center
    B.1.3.4CountryNetherlands
    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 supportStichting VUmc Fonds
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMS Center Amsterdam
    B.5.2Functional name of contact pointInvestigators Office
    B.5.3 Address:
    B.5.3.1Street AddressDe Boelelaan 1117
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1081HV
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31 204440717
    B.5.6E-mails.n.hof@amsterdamumc.nl
    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 Clemastine Milstein 1 mg, tabletten
    D.2.1.1.2Name of the Marketing Authorisation holderMilstein C.V.
    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 nameClemastine fumarate
    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 number4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product 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 Fampyra 10 mg prolonged-release tablets
    D.2.1.1.2Name of the Marketing Authorisation holderBiogen Netherlands B.V
    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 nameFampridine
    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 INNFampridine
    D.3.9.1CAS number 504-24-5
    D.3.9.4EV Substance CodeSUB07505MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Multiple sclerosis (MS)
    Internuclear ophthalmoparesis (INO)
    Multiple sclerose (MS)
    Internucleaire oftalmoplegie (INO)
    E.1.1.1Medical condition in easily understood language
    Multiple sclerosis (MS)
    Eye movement disorder
    Multiple sclerose
    Oogbewegingsstoornis
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10080865
    E.1.2Term Multiple sclerosis lesion
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Our primary objective is to longitudinally evaluate the efficacy of clemastine fumarate to reduce dysconjugacy of horizontal eye movements measured by infrared oculography in patients with MS and internuclear ophthalmoplegia (INO) and to evaluate whether effects meaningfully persist after treatment, representing lasting remyelination.
    Longitudinaal onderzoeken van de effectiviteit van clemastine fumaraat in het verminderen van de dysconjugatie van horizontale oogbewegingen gemeten met infrarood oculografie in patiënten met MS en internucleaire ophthalmoplegie (INO) en om te onderzoeken of deze effecten significant persisteren na behandeling, hetgeen bewijs levert voor blijvende remyelinisatie.
    E.2.2Secondary objectives of the trial
    - To evaluate whether dysconjugacy reduction after a single-dose Fampridine trial prior to treatment with clemastine can predict treatment response to clemastine.
    - To investigate whether treatment with clemastine can induce long term protection against degeneration of retinal layers.
    - To evaluate the effect of clemastine on other eye movement parameters assessed by infrared oculography, such as latency of saccades and proportion of errors in an anti-saccadic task.
    - To evaluate the effect of clemastine on cognition and general disability in MS.
    - To evaluate the effect of clemastine treatment on low and high contrast visual acuity.
    - To evaluate the effect of clemastine treatment on reported subjective visual functioning, fatigue and quality of life.
    - Onderzoeken of een vermindering in dysconjugatie na een eenmalige dosis fampridine, voorafgaand aan de behandeling met clemastine, het effect van clemastine kan voorspellen.
    - Onderzoeken of behandeling met clemastine op de lange termijn bescherming biedt tegen degeneratie van retinale lagen.
    - Onderzoeken wat het effect is van clemastine op andere oogbewegingsparameters gemeten door infrarood oculografie, zoals latentie van saccades en de proportie van fouten in een anti-saccadische taak.
    - Onderzoeken wat het effect is van clemastine op cognitie en algeheel functioneren in MS.
    - Onderzoeken wat het effect is van clemastine op hoog en laag contrast visus.
    - Onderzoeken wat het effect is van clemastine op subjectief visueel functioneren, vermoeidheid en kwaliteit van leven.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. A clinically definite diagnosis of multiple sclerosis.
    2. Diagnosis of internuclear ophthalmoplegia determined by the first infrared oculography at screening with either cut-off of 1.174 of the versional dysconjugacy index area under the curve (VDI-AUC) of 15° saccades or 1.180 of the versional dysconjugacy index peak velocity/saccadic amplitude (VDI-PV/Am) of 15° saccades.
    3. Age 18-70 (inclusive)
    4. Use of disease modifying therapies is not a contraindication.
    5. Ability to understand the purpose and risks of the study and provide signed and dated informed consent.
    1. Een definitieve klinische diagnose van multiple sclerose.
    2. Diagnose van internucleaire oftalmoplegie bepaald door de eerste infrarood oculografie tijdens screening met een "versional dysconjugacy index" (VDI) van de oppervlakte onder de curve (VDI-AUC) bij 15° saccaden boven de 1.174 óf met een "versional dysconjugacy index" van de piek snelheid/saccadische amplitude (VDI-PV/Am) bij 15° saccaden boven de 1.180.
    3. Leeftijd 18 t/m 70 jaar.
    4. Gebruik van ziektemodulerende therapie voor MS is géén contraindicatie.
    5. Deelnemer is in staat het doel en de risico's van de studie te begrijpen en kan getekende en gedateerde informed consent verlenen.
    E.4Principal exclusion criteria
    MS-related exclusion criteria:
    1. Changes in immunomodulatory therapy for multiple sclerosis in the 6 months before inclusion into the study.
    2. Clinical relapse of MS or high dosage corticosteroid use within 30 days before inclusion into the study.

    IMP and medication related exclusion criteria:
    3. Contraindications to clemastine use, such as known porphyria or hypersensitivity to clemastine, other antihistamines with a similar chemical structure or any of the excipients.
    4. Contraindications to fampridine use, such as hypersensitivity to fampridine or any of the excipients, history of epilepsy, kidney disease (GFR <50 ml/min absolute contraindication; GFR = 50-80 ml/min relative contraindication), use of Organic Cation Transporter 2 (OCT2) inhibitors or history of significant cardiac arrhythmias or conduction block.
    5. Concomitant use of Fampridine or any other formulation of 4-aminopyridine (4AP) or diamino4ap that cannot be temporarily suspended prior to each study visit.
    6. Changes in the use of medication currently being investigated in remyelination trials within 6 months before screening, including but not limited to domperidone, liothyronine, quetiapine, testosterone and bazedoxifene.
    7. Non-incidental use of central nervous system depressants including but not limited to hypnotics, anxiolytics, monoamine-oxidase inhibitors (MAOI’S), tricyclic antidepressants, opioid analgesics and other antihistamines with sedating properties (e.g. promethazine).

    Other medical history and concomitant disease exclusion criteria:
    8. History of significant cardiac conduction block.
    9. History of malignancy of any organ system (other than localized squamous or basal cell carcinoma of the skin or adequately treated cervical cancer), treated or untreated, within the past 3 years, regardless of whether there is evidence of local recurrence or metastases.
    10. Estimated glomerular filtration rate (eGFR) < 50 ml/min/1.73 m2; AST, ALT, or alkaline phosphatase > 2 times the upper limit of normal.
    11. Any ophthalmological disease which may prevent accurate infrared oculography assessment.
    12. Suicidal ideation or behaviour in 6 months prior to baseline.
    13. History of drug or alcohol abuse within the past year.
    14. Clinically significant cardiac, metabolic, hematologic, hepatic, immunologic, urologic, endocrinologic, neurologic, pulmonary, psychiatric, dermatologic, allergic, renal or other major diseases that in the PI’s judgement may affect interpretation of study results or patient safety.
    15. History of or presence of clinically significant medical illness or laboratory abnormality that, in the opinion of the investigator would preclude participation in the study.

    General exclusion criteria:
    16. Pregnancy at the time of inclusion into the study or planning on breastfeeding within the first 7 months after inclusion in the study.
    17. Involvement in other study protocol simultaneously without prior approval.
    18. Insufficient proficiency in reading Dutch.
    19. Unable or unwilling to suspend driving for a duration of 6 months.
    MS-gerelateerde exclusie criteria:
    1. Veranderingen in ziektemodulerende therapie voor multiple sclerose binnen 6 maanden voor inclusie in de studie.
    2. Multiple sclerose schub of behandeling met hoge dosis corticosteroiden binnen 30 voor inclusie in de studie.

    IMP en medicatie gerelateerde exclusiecriteria:
    3. Contra-indicaties voor het gebruik van clemastine, zoals bekende porfyrie en overgevoeligheid voor de werkzame stof of voor andere antihistaminica met een vergelijkbare chemische structuur of voor een van de hulpstoffen.
    4. Contra-indicaties voor het gebruik van fampridine, zoals overgevoeligheid voor fampridine of de hulpstoffen, een voorgeschiedenis van epileptische aanvallen, significante nierfunctiestoornis (GFR <50 ml/min is absolute contraindicatie, GFR 50-80ml/min is relatieve contraindicaties), gebruik van "Organic Cation Transporter 2" (OCT-2) remmers of een voorgeschiedenis van signficante cardiale ritme- of geleidingstoornissen.
    5. Gebruik van fampridine of andere geneesmiddelen die 4-aminopyridine bevatten indien dit niet tijdelijk gestopt kan worden voorafgaand aan elk studie bezoek.
    6. Veranderingen in gebruik van medicatie die momenteel wordt onderzocht in remylelinisatie trials in de afgelopen 6 maanden inclusief, maar niet beperkt tot domperidon, liothyronine, quetiapine, testosteron en bazedoxifeen.
    7. Niet-incidenteel gebruik van medicatie met een dempende werking op het centrale zenuwstelsel inclusief, maar niet beperkt tot hypnotica, anxiolytica, monoamine-oxidase (MAO) remmers, tricyclische antidepressiva (TCA's), opioiden en andere anthistamines met sederende effecten (e.g. promethazine).

    Medische voorgeschiedenis gerelateerde exclusie criteria:
    8. Voorgeschiedenis van significante cardiale geleidingsstoornis.
    9. Voorgeschiedenis van maligniteit van een orgaansysteem (anders dan gelokaliseerd plaveisel- of basaalcelcarcinoom van de huid of adequaat behandelde baarmoederhalskanker), behandeld of onbehandeld, in de afgelopen 3 jaar, ongeacht of er aanwijzingen zijn voor lokaal recidief of metastasen.
    10. Ernstige nierfunctiestoornis (eGFR < 50 ml/min/1.73 m2) of leverfunctiestoornis (ASAT, ALAT of alkalisch fosfatase > 2 maal de bovenste referentiewaarde).
    11. Een oogheelkundige aandoening die accurate meting met infrarood oculografie niet toe laat.
    12. Suicidale gedachten of gedrag in de afgelopen 6 maanden.
    13. Voorgeschiedenis van alcohol- of drugsmisbruik in het afgelopen jaar.
    14. Klinisch significante cardiale, metabole, hematologische, hepatische, immunologische, urologische, endocrinologische, neurologische, pulmonaire, psychiatrische, dermatologische, allergische, renale of andere belangrijke medische aandoening die in de mening van de onderzoeker de interpretatie van studie resultaten of patiëntveiligheid in gevaar brengt.
    15. Voorgeschiedenis of aanwezigheid van klinisch significante medische aandoeningen of laboratoriumafwijkingen die in de mening van de onderzoeker deelname aan de studie niet toelaten.

    Algemene exclusie criteria:
    16. Actuele zwangerschap op het moment van inclusie in de studie of van plan zijn om borstvoeding te geven binnen 7 maanden na inclusie in de studie.
    17. Betrokkenheid in een ander onderzoek zonder voorgaande toestemming van de onderzoeker.
    18. Onvoldoende nederlandse leesvaardigheid.
    19. Onvermogen of onwil om het rijden gedurende 6 maanden stop te zetten.
    E.5 End points
    E.5.1Primary end point(s)
    Our main study parameter is the versional dysconjugacy index (VDI) measured by infrared oculography. The relative change in VDI from baseline will be compared between the treatment and control group at the end of treatment (6 months) and multiple follow-up periods (12, 24 and 36 months). The VDI of Area Under The Curve (AUC) will be our primary study parameter. This describes the area under the saccadic trajectory of the horizontal eye position. Other VDI measures (PV, Pv/Am) will be included in the secondary study parameters.
    De hoofd uitkomstmaat van de studie is de "versional dysconjugacy index' (VDI) gemeten met infrarood oculografie. De relatieve verandering in VDI vanaf baseline zal vergeleken worden tussen de interventie- en placebogroep aan het einde van de behandeling (6 maanden) en na verschillende follow-up periodes (12, 24 en 36 maanden). De VDI van het oppervlak onder de curve (VDI-AUC) is de primaire VDI maat. Dit beschrijft het saccadische traject van de horizontale oogbewegingen. Andere VDI maten (PV, PV/Am) worden gebruikt als secundaire uitkomstmaten.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The relative change in VDI from baseline will be compared between the treatment and control group at the end of treatment (6 months) and multiple follow-up periods (12, 24 and 36 months).
    De relatieve verandering in VDI vanaf baseline zal vergeleken worden tussen de interventie- en placebogroep aan het einde van de behandeling (6 maanden) en na verschillende follow-up periodes (12, 24 en 36 maanden).
    E.5.2Secondary end point(s)
    - Changes in other VDI measures (peak velocity (PV) and peak velocity divided by amplitude (PV/Am)).
    - Changes in VDI in response to single dose of Fampridine.
    - Changes in other eye movement parameters measured by infrared oculography, such as: saccade latency, proportion of errors in an anti-saccadic task, proportion of correct double-step saccades and error of the final eye position and infrared pupillary asymmetry
    - Changes in retinal layer thickness on longitudinal OCT, such as (peripheral) retinal nerve fibre layer (pRNFL) and (macular) ganglion cell inner plexiform layer (mGCIPL).
    - Changes in SDMT.
    - Changes in EDSS.
    - Changes in high and low contrast visual acuity (HCVA and LCVA).
    - Changes in subjective visual functioning visual complaints measured by NEI-VFQ-25 and NOV-AU.
    - Changes in quality of life measured by EQ5D-5L.
    - Prevalence and changes in fatigue measured by CIS20R and NFI-MS.
    - Verandering in andere VDI maten (pieksnelheid (PV) en pieksnelheid gedeeld door amplitude (PV/Am)).
    - Verandering in VDI na een eenmalige dosis fampridine.
    - Verandering in andere oogbewegingsparameters gemeten door infrarood oculografie, zoals saccade latentie, proportie van fouten in een anti-saccadische taak, proportie van correctie dubbel-stap saccades en error in de eindpositie van het oog en infrarood pupil assymetrie.
    - Veranderingen in retinale laag dikte op longitudinale OCT, waaronder de perifere retinale zenuwvezel laag (pRNFL) en de maculaire ganglion cell binnenste plexiforme laag (mGCIPL).
    - Veranderingen in SDMT.
    - Veranderingen in EDSS.
    - Veranderingen in hoog en laag contrast visus (HCVA en LCVA).
    - Veranderingen in subjectief visueel functioneren gemeten door de NEI-VFQ-25 en NOV-AU vragenlijsten.
    - Veranderingen in de kwaliteit van leven gemeten door de EQ5D-5L vragenlijst.
    - Prevalentie en verandering in vermoeidheid gemeten door de CIS20R en NFI-MS vragenlijsten.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints will be evaluated at the end of treatment (6 months) and multiple follow-up periods (12, 24 and 36 months).
    Secundaire uitkomstmaten worden geëvalueerd aan het einde van de behandeling (6 maanden) en na verschillende follow-up periodes (12, 24 en 36 maanden).
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    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 months6
    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: 71
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-12-16. Yes
    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 state80
    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)
    None
    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 Decision2021-12-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-14
    P. End of Trial
    P.End of Trial StatusOngoing
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