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    Summary
    EudraCT Number:2017-002866-38
    Sponsor's Protocol Code Number:FM-BOEM
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-08
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-002866-38
    A.3Full title of the trial
    Pilot study for the evaluation of the efficacy of OnabotulinumtoxinA in high frequency migraine
    Studio pilota per la valutazione dell¿efficacia della tossina botulinica A nell¿emicrania ad alta frequenza di attacchi mensili.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the efficacy of OnabotulinumtoxinA in migraine
    Studio per valutare l'efficacia della tossina botulinica A nell'emicrania
    A.3.2Name or abbreviated title of the trial where available
    OnabotulinumtoxinA in migraine
    Tossina botulinica A nell'emicrania
    A.4.1Sponsor's protocol code numberFM-BOEM
    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 SponsorIRCCS FONDAZIONE ISTITUTO NEUROLOGICO NAZIONALE C. MONDINO
    B.1.3.4CountryItaly
    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 supportAllergan
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRCCS Fondazione Istituto Neurologico C. Mondino
    B.5.2Functional name of contact pointClinical Trial Center
    B.5.3 Address:
    B.5.3.1Street AddressVia Mondino, 2
    B.5.3.2Town/ cityPavia
    B.5.3.3Post code27020
    B.5.3.4CountryItaly
    B.5.4Telephone number00390382380385
    B.5.5Fax number00390382380448
    B.5.6E-mailcinzia.fattore@mondino.it
    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 BOTOX - 100 UNIT ALLERGAN POLVERE PER SOLUZIONE INIETTABILE 1 FLACONCINO
    D.2.1.1.2Name of the Marketing Authorisation holderALLERGAN PHARMACEUTICALS IRELAND
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 nametossina botulinica A
    D.3.2Product code M03AX01
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    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 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 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
    Migraine
    Emicrania
    E.1.1.1Medical condition in easily understood language
    Migraine
    Emicrania
    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 10027599
    E.1.2Term Migraine
    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
    Evaluate the efficacy of BoNT-A in reducing the number of migraine days/month in one year
    Valutare l¿efficacia di BoNT-A nel ridurre il numero di giorni mensili con emicrania in un anno
    E.2.2Secondary objectives of the trial
    ¿ Monthly headache days;
    ¿ Mean migraine attack intensity;
    ¿ Monthly use of acute drugs;
    ¿ Migraine-related disability
    ¿ Quality of life
    ¿ Levels of anxiety and depression
    - Giorni mensili di cefalea
    - Intensit¿ media del dolore dell¿attacco di emicrania
    - Frequenza di assunzione di farmaci sintomatici
    - Disabilit¿ correlata all¿emicrania
    - Impatto sulla qualit¿ della vita
    - Livelli di ansia e depressione
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Subjects fulfilling the diagnostic criteria for migraine without or with aura of the International Headache Classification with a number of migraine days ranging from 9 to 14 days/month in the previous 3 months.
    • The frequency needs to be confirmed over the 28 days before the screening visit (Lipton et al., Cephalalgia 2011, The INTREPID study).
    • Subjects have to be in general good health, as confirmed by medical history, baseline physical examination, baseline neurological exam and vital signs.
    • Females have to be postmenopausal for at least one year, surgically sterile or otherwise incapable of pregnancy, or using an acceptable method of birth control.
    • Age between 18-65 years old
    - Soggetti che soddisfino i criteri per emicrania con o senza aura della Classificazione Internazionale delle Cefalee con 9-14 giorni di emicrania al mese negli ultimi 3 mesi. La frequenza deve essere confermata mediante compilazione di un diario della cefalea nelle 4 settimane prima della visita di screening (Lipton et al., Cephalalgia 2011, The INTREPID study).
    - I soggetti devono essere in buona salute, così come desunto dall’analisi anamnestica, dalla valutazione medica generale e neurologica e dalla raccolta dei parametri vitali.
    - I soggetti di sesso femminile devono essere in fase post menopausale da almeno un anno o impossibiliti ad avere una gravidanza per sterilità post chirurgica o qualsiasi altra causa accertata o, qualora in età fertile, devono utilizzare un efficace metodo contraccettivo.
    - Età compresa tra i 18 e 65 anni.
    E.4Principal exclusion criteria
    • Previous failure of more than two adequate trials of medications from different drug classes used for migraine prophylaxis;
    • Onset of migraine after age 50;
    • Exclusively migraine aura without headache;
    • Diagnosis of other primary or secondary headache disorders. Episodic tension-tyep headache is allowed if the patient can distinguish clearly between attack of migraine and of tension-type headache;
    • Another chronic painful condition (e.g. osteoarthritis, low back pain);
    • A significant medical history or medical condition of neurological, cardiovascular hepatic or renal disease;
    • History of suicide attempt or suicidal ideation or of a major psychiatric disorder;
    • History of drug or alcohol abuse within the past two years.
    • Known hypersensitivity to botulinum toxin type A or to any of the other ingredients used to form ‘Botox®’
    - Precedente fallimento di più di due adeguati trattamenti, con farmaci appartenenti a classi farmacologiche differenti utilizzate per la profilassi dell’emicrania.
    - Insorgenza dell’emicrania dopo i 50 anni.
    - Diagnosi esclusiva di aura emicranica senza cefalea.
    - Qualsiasi altra condizione determinante dolore cronico (come artrosi, dolore lombare) o cefalea a grappolo o emicrania emiplegica o basilare.
    - Una storia anamnestica significativa per patologie neurologiche, cardiovascolari, epatiche o renali.
    - Una storia anamnestica significativa per patologie psichiatriche, idee o agiti autolesivi o tentativi di suicidio.
    - Una storia anamnestica di abuso alcolico o di sostanze negli ultimi 2 anni.
    - Nota ipersensibilità al BoNT-A o a qualsiasi degli ingredienti che compongono Botox
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy will be calculated in terms of absolute and percent reduction of migraine days/month
    L’efficacia verrà calcolata in termini assoluti e come riduzione percentuale dei giorni/mese di emicrania.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Last 16 weeks of the study period as compared to the 4 baseline weeks.
    Ultime 16 settimane di osservazione rispetto al basale, normalizzati a 4 settimane.
    E.5.2Secondary end point(s)
    Monthly headache days; Mean migraine attack intensity; Monthly use of acute drugs; Migraine-related disability; Quality of life; Levels of anxiety and depression
    Giorni mensili di cefalea; Intensit¿ media del dolore dell¿attacco di emicrania; Frequenza di assunzione di farmaci sintomatici; Disabilit¿ correlata all¿emicrania; Impatto sulla qualit¿ della vita; Livelli di ansia e depressione
    E.5.2.1Timepoint(s) of evaluation of this end point
    Last 16 weeks of the study period as compared to the 4 baseline weeks.; Last 16 weeks of the study period as compared to the 4 baseline weeks.; Last 16 weeks of the study period as compared to the 4 baseline weeks.; Last 16 weeks of the study period as compared to the 4 baseline weeks.; Last 16 weeks of the study period as compared to the 4 baseline weeks.; Last 16 weeks of the study period as compared to the 4 baseline weeks.
    Ultime 16 settimane di osservazione rispetto al basale, normalizzati a 4 settimane.; Ultime 16 settimane di osservazione rispetto al basale, normalizzati a 4 settimane.; Ultime 16 settimane di osservazione rispetto al basale, normalizzati a 4 settimane.; Ultime 16 settimane di osservazione rispetto al basale, normalizzati a 4 settimane.; Ultime 16 settimane di osservazione rispetto al basale, normalizzati a 4 settimane.; Ultime 16 settimane di osservazione rispetto al basale, normalizzati a 4 settimane.
    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 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.8.2.4Number of treatment arms in the trial1
    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.8.4.1Number of sites anticipated in Member State concerned1
    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 Information not present in EudraCT
    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 years1
    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 years1
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state42
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 42
    F.4.2.2In the whole clinical trial 42
    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 study, subjects enrolled will be monitored for the subsequent 3 months and scheduled for a follow-up visit at the Headache Centre at the end of the 3-month period.
    During this visit, the neurologist will evaluate the diaries and define the preventive/symptomatic treatment.
    Al termine della loro partecipazione allo studio, i soggetti arruolati saranno monitorati per i successivi 3 mesi e, al termine del terzo mese, sar¿ programmata una visita all'Headache Center. Durante questa visita il neurologo verificher¿ i diari e definir¿ la terapia sintomatica/preventiva.
    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 Decision2018-01-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-20
    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
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