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    Summary
    EudraCT Number:2016-001635-12
    Sponsor's Protocol Code Number:M15-562
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-02-05
    Trial results View 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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2016-001635-12
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Progressive Supranuclear Palsy
    Sperimentazione randomizzata, in doppio cieco, controllata da placebo, a dosi multiple per valutare l’efficacia, la sicurezza, la tollerabilità e la farmacocinetica di ABBV-8E12 nella paralisi sopranucleare progressiva.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy, Safety , Tolerability and Pharmacokinetics of ABBV-8E12 in Subjects with Progressive Supranuclear Palsy.
    Sperimentazione per valutare l’efficacia, la sicurezza, la tollerabilità e la farmacocinetica di ABBV-8E12 in soggetti con paralisi sopranucleare progressiva.
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberM15-562
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02985879
    A.5.4Other Identifiers
    Name:NANumber:M15-562
    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 SponsorABBVIE DEUTSCHLAND GMBH & CO. KG
    B.1.3.4CountryGermany
    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 supportAzienda Farmaceutica: AbbVie Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Ltd
    B.5.2Functional name of contact pointEU Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbVie House, Vanwall Business park; Vanwall Road
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00441628561090
    B.5.5Fax number00441628461153
    B.5.6E-maileu-clinical-trials@abbvie.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEMA/OD/239/15
    D.3 Description of the IMP
    D.3.1Product nameABBV-8E12
    D.3.2Product code ABBV-8E12
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNABBV-8E12
    D.3.9.2Current sponsor codeABBV-8E12
    D.3.9.4EV Substance CodeSUB183488
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 No
    D.3.11.9Recombinant medicinal product Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeHumanized IgG4 anti-tau monoclonal antibody
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Progressive Supranuclear Palsy
    Paralisi sopranucleare progressiva
    E.1.1.1Medical condition in easily understood language
    PSP is a disease that attacks the brain, causing problems with body movement, memory, thinking, and behavior. Symptoms get worse over time and eventually make doing normal, daily tasks impossible.
    PSP è una malattia che attacca il cervello,causando probl.con il movim.del corpo,memoria,pensiero e comportamento.I sintomi peggiorano nel tempo e alla fine rendono le norm.attività quotid.impossibili
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10036813
    E.1.2Term Progressive supranuclear palsy
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To assess the efficacy of ABBV-8E12 in slowing disease progression in subjects with progressive supranuclear palsy as measured by the PSP Rating Scale (PSP-RS).
    - To assess the long term safety and tolerability of ABBV-8E12 for up to 52 weeks in subjects with progressive supranuclear palsy.
    - Valutare l’efficacia di ABBV-8E12 nel rallentare la progressione della malattia in soggetti affetti da paralisi sopranucleare progressiva mediante la scala di valutazione PSP (PSP-RS).
    - Valutare la sicurezza e la tollerabilità a lungo termine di ABBV-8E12 per un massimo di 52 settimane in soggetti affetti da paralisi sopranucleare progressiva.
    E.2.2Secondary objectives of the trial
    - To assess the pharmacokinetics of ABBV-8E12 in subjects with PSP.
    - To assess the efficacy of ABBV-8E12 in slowing disease progression and functional impairment in subjects with PSP as measured by secondary endpoints.
    - To assess the efficacy of ABBV-8E12 in slowing regional and/or whole brain atrophy in subjects with PSP as measured by volumetric MRI.
    - Valutare la farmacocinetica di ABBV-8E12 in soggetti affetti da paralisi sopranucleare progressiva.
    - Valutare l’efficacia di ABBV-8E12 nel rallentare la progressione della malattia e il deterioramento funzionale in soggetti affetti da paralisi sopranucleare progressiva come misurato dagli endpoints secondari.
    - Valutare l’efficacia di ABBV-8E12 nel rallentare l’atrofia cerebrale regionale e/o globale in soggetti affetti da paralisi sopranucleare progressiva come misurato dalla RMN volumetrica.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female subject with age 40 years or greater at the time of signed consent.
    • Meets the following criteria for possible or probable progressive supranuclear palsy (Steele-Richardson-Olszewski Syndrome)
    - gradually progressive disorder, with age at disease onset greater than or equal to 40 years
    - either or both of the following two items are met:
    1. vertical supranuclear gaze palsy
    2. slowing of vertical saccades AND postural instability with falls within the first 3 years of PSP symptoms
    • Presence of PSP symptoms for less than 5 years.
    • Subject is able to walk 5 steps with minimal assistance (stabilization of one arm or use of cane/walker).
    • Subject has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend).
    • Soggetto maschio o femmina di 40 anni o età superiore al momento della firma del consenso informato.
    • Soddisfa i seguenti criteri per una possibile o probabile paralisi sopranucleare progressiva (sindrome di Steele-Richardson-Olszewski):
    - disturbo gradualmente progressivo, con un’età pari o superiore ai 40 anni al momento dell’insorgenza della malattia
    - uno o entrambi i seguenti due criteri sono soddisfatti:
    1. paralisi sopranucleare dello sguardo verticale
    2. rallentamento dei movimenti saccadici verticali e instabilità posturale con cadute entro i primi 3 anni di sintomi della PSP
    • Presenza di sintomi di PSP da meno di 5 anni.
    • Il soggetto è in grado di fare 5 passi con il minimo intervento (stabilizzazione di un braccio o uso di bastone/deambulatore).
    • Il soggetto ha un partner di studio identificato, affidabile (ad es., operatore sanitario, membro della famiglia, assistente sociale, o amico).
    E.4Principal exclusion criteria
    • Subjects who weigh less than 44 kg (97 lbs) at screening.
    • MMSE score less than 15 at screening
    • Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI)
    • Subject resides at a skilled nursing or dementia care facility, or admission to such a facility is planned during the study period.
    • Evidence of any clinically significant neurological disorder other than PSP
    • The subject has a history of or currently has schizophrenia, schizoaffective disorder or bipolar disorder according to DSM-V or ICD-10 criteria.
    • Subject has had a significant illness or infection requiring medical intervention in the past 30 days.
    • Soggetti che pesano meno di 44 kg (97 libbre) al momento dello screening.
    • Un punteggio MMSE inferiore a 15 al momento dello screening
    • Eventuali controindicazioni o incapacità di tollerare la risonanza magnetica (RM) al cervello
    • Il soggetto si trova presso una struttura specializzata di assistenza infermieristica o di cura per le demenze, oppure è previsto il ricovero in una struttura simile durante il periodo della sperimentazione.
    • Evidenza di un qualsiasi altro disturbo neurologico clinicamente significativo diverso dalla PSP
    • Il soggetto ha una storia o presenta attualmente schizofrenia, disturbo schizoaffettivo o disturbo bipolare secondo i criteri DSM-V o ICD-10.
    • Il soggetto ha avuto una malattia significativa o un’infezione richiedente l’intervento medico negli ultimi 30 giorni.
    E.5 End points
    E.5.1Primary end point(s)
    The change from baseline to Week 52 on the PSP-RS total score.
    La variazione del punteggio totale PSP-RS dal basale alla Settimana 52.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Weeks 12, 24, 36 and 52
    Settimane 12, 24, 36 e 52
    E.5.2Secondary end point(s)
    1. To assess the pharmacokinetics of ABBV-8E12 in subjects with progressive supranuclear palsy. 2. To assess the efficacy of ABBV-8E12 in slowing disease progression and functional impairment in subjects with progressive supranuclear palsy as measured by the SEADL, UPDRS Part II, CGI-S, CGI-C, and PSPQoL. 3. To assess the efficacy of ABBV-8E12 in slowing regional and/or whole brain atrophy in subjects with progressive supranuclear palsy as measured by volumetric MRI.
    1. Valutare la farmacocinetica di ABBV-8E12 in soggetti affetti da paralisi sopranucleare progressiva. 2. Valutare l’efficacia di ABBV-8E12 nel rallentare la progressione della malattia e il deterioramento funzionale in soggetti affetti da paralisi sopranucleare progressiva come misurato dalle scale di valutazione SEADL, UPDRS Parte II,CGI-S, CGI-C e PSP-QoL. 3. Valutare l’efficacia di ABBV-8E12 nel rallentare l’atrofia cerebrale regionale e/o globale in soggetti affetti da paralisi sopranucleare progressiva come misurato dalla RMN volumetrica.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Day 1, Day 5 (C1), Day 15, Day 29, Day 57 (C1), Day 85, Day 89 (C1), Day 99 (C1), Week 16 (C1), Week 24, Week 36, Week 52, Week 60, Week 68 2. SEADL, UPDRS, – Screen, Day 1, Week 12, Week 24, Week 36, Week 52 CGI-S-SV1, SV2, Day 1, Week 8, Week 12, Week 20, Week 24, Week 32, Week 36, Week 48 and Week 52 CGI-C-Weeks 8, Week 12, Week 20, Week 24, Week 32, Week 36, Week 48 and Week 52 PSP-QoL-SV1, Day 1, Week 12, Week 24, Week 36, Week 52 3. Screen, Day 15 (C1), Week 12, Week 24, Week 52
    1.Giorno1,Giorno5(Coorte1),Giorno15,Giorno29,Giorno57(Coorte1),Giorno85,Giorno8(Coorte1),Giorno99(Coort 1),Sett16(Coorte1),Sett24,Sett 36,Sett52,Sett60,Sett68 2.Scala di Schwab e England Activities of Daily Living(SEADL),ScalaUPDRS(Unified Parkinson’s Disease Rating Scale,Scala Unificata per la Valutazione della Gravità della Malattia di Parkinson),–Screen,Giorno1,Sett12,Sett24,Sett36,Sett52.Impressione clinica globale della gravità-Visita di Screening1(CGI-S-SV1),Visita di Screening2(SV2),Giorno1,Sett 8,Sett 12,Sett 20,Sett 24,32,36,48 e 52 Impressione clinica globale del miglioramento(CGI-C)-Sett8,Sett12,Sett 20,Sett24,Sett32,Sett36,Sett48 e Sett52 Scala della qualità della vita PSP -Visita di Screening1(PSP-QoL-SV1),Giorno1,Sett 12,24,36,52 3.Screen,Giorno15(Coorte1),Sett12,24,52
    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 Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    Australia
    Canada
    United States
    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 years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days20
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days20
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 130
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 180
    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)
    Possible Long Term Extension study or return to standard of care
    Potrebbe essere previsto uno studio di estensione a lungo termine o il ritorno al trattamento standard
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Cure PSP (Patient Advocacy)
    G.4.3.4Network Country United States
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-05-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-11-20
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