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    Summary
    EudraCT Number:2016-000700-29
    Sponsor's Protocol Code Number:MD1003CT2016-01MS-SPI2
    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:2020-11-05
    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 number2016-000700-29
    A.3Full title of the trial
    Effect of MD1003 in progressive multiple sclerosis: a randomized double-blind placebo-controlled study
    Effetto di MD1003 nella sclerosi multipla progressiva: studio randomizzato, in doppio cieco, controllato verso placebo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of MD1003 in progressive multiple sclerosis with walking impairment
    Effetto di MD1003 nella sclerosi multipla progressiva con ridotta funzionalità deambulatoria
    A.3.2Name or abbreviated title of the trial where available
    SPI2
    SPI2
    A.4.1Sponsor's protocol code numberMD1003CT2016-01MS-SPI2
    A.5.4Other Identifiers
    Name:ClinicalTrials.govNumber:NCT02936037
    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 SponsorMEDDAY PHARMACEUTICALS
    B.1.3.4CountryFrance
    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 supportMedday pharmaceuticals SA
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedday Pharmaceuticals
    B.5.2Functional name of contact pointclinical trials information desk
    B.5.3 Address:
    B.5.3.1Street Address24-26 rue de la Pépinière
    B.5.3.2Town/ cityParigi
    B.5.3.3Post code75008
    B.5.3.4CountryFrance
    B.5.4Telephone number00330181516672
    B.5.5Fax number00330181516677
    B.5.6E-mailabdelkarim.bendarraz@medday-pharma.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameD-Biotin
    D.3.2Product code [MD1003]
    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 INND-BIOTINA
    D.3.9.1CAS number 58-85-5
    D.3.9.2Current sponsor codeMD1003
    D.3.9.3Other descriptive name-
    D.3.9.4EV Substance CodeSUB32335
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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, hard
    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
    Sclerosi multipla
    E.1.1.1Medical condition in easily understood language
    Multiple sclerosis
    Sclerosi multipla
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To confirm the superiority of MD1003, 300 mg/day, over placebo to clinically improve patients with not active progressive multiple sclerosis (MS).
    Confermare la superiorità di MD1003, 300 mg/die, su placebo nel migliorare la condizione clinica di pazienti affetti da sclerosi multipla (SM) progressiva non attiva.
    E.2.2Secondary objectives of the trial
    To evaluate the safety of MD1003
    Valutare la sicurezza di MD1003
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient aged 18-65 years old
    2. Signed and dated written informed consent form in accordance with local regulations: having freely given their written informed consent to participate in the study
    3. Diagnosis of primary or secondary progressive MS fulfilling revised McDonald criteria (2010) and Lublin criteria (2014)
    4. Documented evidence of clinical disability progression within the 2 years prior to inclusion, i.e. a) progression of EDSS during the past two years of at least 1 point sustained for at least 6 months if inclusion EDSS is from 3.5 to 5.5 or at least 0.5 point increase sustained for at least 6 months if inclusion EDSS is from 6 to 6.5 or b) increase of TW25 by at least 20% in the last two years sustained for at least 6 months or c) other well-documented objective worsening validated by the Adjudication Committee
    5. EDSS at inclusion from 3.5 to 6.5
    6. TW25 < 40 seconds
    7. Kurtzke pyramidal functional subscore =2 defined as “minimal disability: patient complains of motor-fatigability or reduced performance in strenuous motor tasks (motor performance grade 1) and/or BMRC grade 4 in one or two muscle groups”
    1. Età compresa tra 18 e 65 anni
    2. Modulo di consenso informato firmato e datato in conformità con le normative locali: consenso informato scritto alla partecipazione allo studio fornito volontariamente
    3. Diagnosi di SM progressiva primaria o secondaria che soddisfa i criteri di McDonald rivisti (2010) e i criteri di Lublin (2014)
    4. Evidenze documentate di progressione della disabilità clinica nei 2 anni antecedenti all’inclusione, ovvero: a) progressione di almeno 1 punto del punteggio EDSS nei due anni precedenti, osservata per almeno 6 mesi se il punteggio EDSS all’inclusione è di 3,5-5,5, o incremento di almeno 0,5 punti osservato per almeno 6 mesi se il punteggio EDSS all’inclusione è di 6-6,5; oppure b) aumento di almeno il 20% del tempo necessario a percorrere a piedi ca. 8 m (Timed 25-Foot Walk test - TW25) negli ultimi due anni osservato per almeno 6 mesi; oppure c) altro peggioramento oggettivo ben documentato confermato dal Comitato di valutazione
    5. Punteggio EDSS all’inclusione compreso tra 3,5 e 6,5
    6. TW25 < 40 secondi
    7. Sottopunteggio relativo alle funzioni piramidali della scala di Kurtzke =2, definito come “disabilità minima: il/la paziente lamenta affaticamento motorio o ridotta capacità di compiere attività motorie faticose (grado di abilità motoria pari a 1) e/o grado BMRC pari a 4 in uno o due distretti muscolari”
    E.4Principal exclusion criteria
    1. Clinical evidence of a relapse in 24 months prior to inclusion
    2. Treatment with any product containing biotin as single ingredient within six months prior to inclusion (multivitamin supplementation authorized if biotin < 1mg per day)
    3. Concomitant treatment with fampridine at inclusion or in the 30 days prior to inclusion
    4. New immunosuppressive/immunomodulatory drug initiated less than 90 days prior to inclusion
    5. Treatment with botulinium toxin (except for cosmetic purpose) initiated within 6 months prior to inclusion
    6. In-patient rehabilitation program within the 3 months prior to inclusion
    7. Pregnancy, breastfeeding or women with childbearing potential without acceptable form of contraception
    8. Men unwilling to use an acceptable form of contraception
    9. Any general chronic handicapping/incapacitating disease other than MS
    10. Any serious disease necessitating biological follow-up with biological tests using biotinylated antibodies or substrates
    11. Past history of rhabdomyolysis/metabolic myopathy
    12. Known fatty acids beta oxidation defect
    13. Known hypersensitivity or intolerance to biotin, analogues or excipients, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
    14. Patients with hypersensitivity to Gadolinium or any contraindication to MRI
    15. Patients with uncontrolled hepatic disorder, renal or cardiovascular disease, or cancer
    16. Laboratory tests out of normal ranges considered by the investigator as clinically significant with regards to the study continuation
    17. Patients with history or presence of alcohol abuse or drug addiction
    18. Untreated or uncontrolled psychiatric disorders, especially suicidal risk assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
    19. Participation in another research study involving an investigational product (IP) in the 90 days prior to inclusion, or planned use during the study duration
    20. Patients likely to be non-compliant to the study procedures or for whom a long-term follow-up seems to be difficult to achieve
    21. Relapse that occurs between inclusion and randomization visit
    1. Evidenze cliniche di recidiva nei 24 mesi precedenti all’inclusione
    2. Trattamento con qualsiasi prodotto contenente biotina come unico ingrediente nei sei mesi precedenti all’inclusione (è consentita l’integrazione multivitaminica se la quantità di biotina è <1 mg/die)
    3. Trattamento concomitante con fampridina all’inclusione o nei 30 giorni precedenti
    4. Inizio di una terapia con un nuovo farmaco immunosoppressore/immunomodulatore nei 90 giorni precedenti all’inclusione
    5. Trattamento con tossina botulinica (salvo che a fini estetici) iniziato nei 6 mesi precedenti all’inclusione
    6. Programma di riabilitazione ambulatoriale nei 3 mesi precedente all’inclusione
    7. Gravidanza, allattamento o donne in età fertile che non utilizzano metodi di contraccezione accettabili
    8. Uomini non disposti a utilizzare un metodo di contraccezione accettabile
    9. Qualsiasi malattia cronica invalidante generalizzata diversa dalla SM
    10. Qualsiasi malattia seria che necessita di follow-up biologico con test biologici a base di anticorpi o substrati biotinilati
    11. Storia di rabdomiolisi/miopatia metabolica
    12. Difetti noti di beta-ossidazione degli acidi grassi
    13. Ipersensibilità o intolleranza nota alla biotina, ai suoi analoghi o eccipienti; pazienti con rari disturbi ereditari di intolleranza al galattosio, deficit di Lapp-lattasi o malassorbimento di glucosio-galattosio
    14. Ipersensibilità al gadolinio o qualsiasi controindicazione alla RMI
    15. Disturbo epatico non controllato, malattia renale o cardiovascolare o
    cancro
    16. Risultati degli esami di laboratorio al di fuori dei valori normali, ritenuti
    clinicamente significativi dallo sperimentatore per la prosecuzione dello studio
    17. Pazienti con attuale o passata dipendenza da alcol o sostanze stupefacenti
    18. Disturbi psichiatrici non trattati o non controllati, in particolare rischio suicidario valutato in base alla scala C-SSRS (Columbia-Suicide Severity Rating Scale)
    19. Partecipazione a un altro studio di ricerca che prevede l’utilizzo di un prodotto sperimentale (IP) nei 90 giorni precedenti all’inclusione o uso previsto di un IP nel corso dello studio
    20. Probabile non-compliance alle procedure di studio o verosimile difficoltà di un follow-up a lungo termine
    21. Recidiva tra la visita di inclusione e di randomizzazione
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint: Proportions of patients: - with decreased EDSS at M12 confirmed at M15 (where decreased EDSS is defined as a decrease of at least 1 point if initial EDSS from 3.5 to 5.5 and of at least 0.5 point if initial EDSS from 6 to 6.5) or - with improved TW25 of at least 20% at M12 and M15 compared to the lowest of the two EDSS and TW25 scores among inclusion and randomization visits.
    Endpoint primario di efficacia Percentuali di pazienti: - con riduzione del punteggio EDSS al mese 12 (M12) confermata al M15 (laddove la riduzione del punteggio EDSS è definita come una riduzione di almeno 1 punto se il punteggio EDSS iniziale è compreso tra 3,5 e 5,5 e di almeno 0,5 punti se il punteggio EDSS iniziale è compreso tra 6 e 6,5) oppure • con un miglioramento pari ad almeno il 20% al test TW25 al M12 e al M15 rispetto al più basso dei due punteggi EDSS e TW25* determinati alle visite di inclusione e di randomizzazione.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 12 and 15
    Mese 12 e 15
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints
    1. Time to EDSS progression confirmed at 12 weeks
    2. Mean difference between treatment arms in CGI at M15;
    3. Mean difference between treatment arms in SGI at M15;
    5. Mean change in TW25 score between M0 and the last visit in doubleblind phase of any particular patient (M15, M18, M21, M24 or M27 or Early Termination).

    - Exploratory endpoints
    1. Brain MRI measurements will assess the following endpoints between M0 and M15 (and between M0 and M27 and every year until the end of the study)
    a. Percent whole brain volume
    b. Percent thalamic volume
    c. Percent cortical grey matter volume
    d. Brain water content evaluated by Pseudo T2 relaxation time
    e. NAA/Cr in a subset of sites acquiring MRS

    2. Remote monitoring of ambulation
    3. Multiple Sclerosis Quality of Life-54 (MSQOL54) and Caregiver healthrelated quality of life in Multiple Sclerosis (CAREQOL-MS) subscores and composite scores
    4. Subscores of the Kurtzke functional score
    5. Symbol digit modalities test (SDMT)

    Safety evaluation
    a. Recording of AEs
    b. Laboratory testing (standard hematology and biochemistry panel)
    c. ECG: PR, QRS, QT and RR interval, HR and QTcF, wave morphology,
    rhythm and conduction
    d. Brain MRI: new or enlarging T2 lesions and Gd+ lesions
    e. Columbia-Suicide Severity Rating Scale
    Endpoint secondari di efficacia
    1. Tempo alla progressione del punteggio EDSS confermata a 12 settimane
    -2. Differenza media tra i bracci di trattamento secondo l’impressione clinica globale (CGI) al M15
    3. Differenza media tra i bracci di trattamento secondo l’impressione globale del soggetto (SGI) al M15
    4. Variazione media del valore di TW25 tra il M0 e il M15
    5. Variazione media del punteggio TW25 tra il M0 e l’ultima visita della fase in doppio cieco di un paziente specifico (M15, M18, M21, M24 o M27, o interruzione anticipata)

    Endpoint esplorativi
    - Endpoint esplorativi
    1. Mediante misurazioni con RM cerebrale si valuteranno i seguenti endpoint tra il M0 e il M15 (e tra il M0 e il M27, e ogni anno fino alla fine dello studio)
    a. Volume percentuale di tutto il cervello
    b. Volume talamico percentuale
    c. Volume percentuale della materia grigia corticale

    d. Variazione del contenuto cerebrale di acqua valutato in base al tempo di pseudo rilassamento T2
    e. NAA/Cr in un sottoinsieme di centri dotati di spettrometro NRM
    2. Monitoraggio remoto della deambulazione.
    3. Sottopunteggi e punteggi compositi ai questionari MSQOL54 (Multiple Sclerosis Quality of Life-54) e CAREQOL-MS (Caregiver health-related Quality of Life in Multiple Sclerosis)
    4. Sottopunteggi alla scala funzionale di Kurtzke
    5. Test SDMT (Symbol Digit Modalities Test)

    Valutazione di sicurezza
    a. Registrazione degli AE
    b. Esami di laboratorio (parametri ematologici ed ematochimici standard)
    c. ECG: intervallo PR, QRS, QT ed RR, frequenza cardiaca (HR) e intervallo QT corretto con formula di Fridericia (QTcF), morfologia dell’onda, ritmo e conduzione
    d. RM cerebrale: lesioni in T2 nuove o ingrandite e lesioni Gd+
    e. Columbia-Suicide Severity Rating Scale (C-SSRS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12, Month 15, Month 27, the last visit in double-blind phase (M15,
    M18, M21, M24 or M27 or Early Termination)
    Settimana 12, Mese 15, Mese 27, ultima visita della fase in doppio cieco (M15, M18, M21, M24 o M27, o interruzione anticipata)
    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) 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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 Information not present in EudraCT
    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
    Belgium
    Canada
    Czechia
    Germany
    Hungary
    Italy
    Netherlands
    Poland
    Spain
    Sweden
    Turkey
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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 months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days0
    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: 745
    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 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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 166
    F.4.2.2In the whole clinical trial 754
    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
    Cure standard
    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 Decision2017-01-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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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
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