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    Summary
    EudraCT Number:2017-004828-29
    Sponsor's Protocol Code Number:17I-DCsc09
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-11-04
    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 number2017-004828-29
    A.3Full title of the trial
    A pilot, double-blind, randomized, placebo-controlled, dose finding, proof of concept study to evaluate efficacy, safety and tolerability of self- administered subcutaneous diclofenac sodium 25-50-75mg/1ml in the treatment of an acute migraine attack with headache.
    Studio pilota, “proof of concept”, in doppio cieco, randomizzato, controllato verso placebo per definire la dose ottimale, valutare l'efficacia, la sicurezza e la tollerabilità di Diclofenac sodico 25-50-75mg/1 ml sottocutaneo, auto-somministrato, nel trattamento di un attacco acuto di emicrania con cefalea.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to define the optimal dose, to evaluate efficacy, safety and tolerability of self- administered subcutaneous diclofenac sodium 25-50-75mg/1ml in the treatment of an acute migraine attack with headache.
    Studio per definire la dose ottimale, valutare l'efficacia, la sicurezza e la tollerabilità di Diclofenac sodico 25-50-75mg/1 ml sottocutaneo, auto-somministrato, nel trattamento di un attacco acuto di emicrania con mal di testa.
    A.3.2Name or abbreviated title of the trial where available
    17I-DCsc09
    17I-DCsc09
    A.4.1Sponsor's protocol code number17I-DCsc09
    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 SponsorIBSA INSTITUT BIOCHIMIQUE SA
    B.1.3.4CountrySwitzerland
    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 supportIBSA INSTITUT BIOCHIMIQUE SA
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharmaceutical Development and Services srl
    B.5.2Functional name of contact pointServizio Informazione sulla Sperime
    B.5.3 Address:
    B.5.3.1Street Addressvia dei Pratoni, 16
    B.5.3.2Town/ cityScandicci (FI)
    B.5.3.3Post code50018
    B.5.3.4CountryItaly
    B.5.4Telephone number0557224179
    B.5.5Fax number0557227014
    B.5.6E-mailedimartino@pharmades.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 AKIS - 25 MG/ML SOLUZIONE INIETTABILE 1 SIRINGA PRERIEMPITA CON AGO
    D.2.1.1.2Name of the Marketing Authorisation holderIBSA FARMACEUTICI ITALIA S.R.L.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameAKIS - 25 MG/ML SOLUZIONE INIETTABILE 1 SIRINGA PRERIEMPITA CON AGO
    D.3.2Product code AKIS - 25 MG/ML SOLUZIONE INIETTABILE 1 SIRINGA PR
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDICLOFENAC SODICO
    D.3.9.1CAS number 15307-86-5
    D.3.9.2Current sponsor codeDICLOFENAC SODICO
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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.IMP: 2
    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 AKIS - 50 MG/ML SOLUZIONE INIETTABILE 1 SIRINGA PRERIEMPITA CON AGO
    D.2.1.1.2Name of the Marketing Authorisation holderIBSA FARMACEUTICI ITALIA S.R.L.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameAKIS - 50 MG/ML SOLUZIONE INIETTABILE 1 SIRINGA PRERIEMPITA CON AGO
    D.3.2Product code AKIS - 50 MG/ML SOLUZIONE INIETTABILE 1 SIRINGA PR
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDICLOFENAC SODICO
    D.3.9.1CAS number 15307-86-5
    D.3.9.2Current sponsor codeDICLOFENAC SODICO
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.IMP: 3
    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 AKIS - 75 MG/ML SOLUZIONE INIETTABILE 1 SIRINGA PRERIEMPITA CON AGHI
    D.2.1.1.2Name of the Marketing Authorisation holderIBSA FARMACEUTICI ITALIA S.R.L.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameAKIS - 75 MG/ML SOLUZIONE INIETTABILE 1 SIRINGA PRERIEMPITA CON AGHI
    D.3.2Product code AKIS - 75 MG/ML SOLUZIONE INIETTABILE 1 SIRINGA PR
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDICLOFENAC SODICO
    D.3.9.1CAS number 15307-86-5
    D.3.9.2Current sponsor codeDICLOFENAC SODICO
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute migraine attacks with headache.
    Attacchi acuti di emicrania con cefalea.
    E.1.1.1Medical condition in easily understood language
    Acute migraine attacks with headache.
    Attacchi acuti di emicrania con mal di testa
    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 SOC
    E.1.2Classification code 10029205
    E.1.2Term Nervous system disorders
    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 evaluate the efficacy of diclofenac sodium administered subcutaneously at three different doses (25-50-75 mg/1ml) in comparison to placebo in the treatment of an acute migraine attack with headache.
    valutare l'efficacia di Diclofenac sodico somministrato per via sottocutanea in tre diversi dosaggi (25, 50 e 75 mg/1ml) rispetto ad un placebo nel trattamento di un attacco acuto di emicrania con cefalea.
    E.2.2Secondary objectives of the trial
    To select the most suitable dose(s) of diclofenac sodium subcutaneous injection in order to implement successive pivotal clinical trials and to evaluate safety and tolerability of diclofenac sodium as a self- administered treatment of an acute migraine attack with headache.
    Scegliere la dose o le dosi più idonee di Diclofenac sodico somministrato per via sottocutanea per effettuare studi clinici successivi e valutare la sicurezza e la tollerabilità del Diclofenac sodico auto-somministro nel trattamento di un attacco acuto di emicrania con cefalea.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects eligible for this study must meet all the following criteria:
    1. Male and female, with an age between 18 and 65 years
    2. Subjects with migraine with or without aura, according to ICHD-3criteria since at least 1 year and with 3 months of well documented retrospective history
    3. Subjects with migraine onset before 50 years of age
    4. Subjects with a history of migraine attacks typically lasting between 4 and 72 hours if untreated or treated unsuccessfully and with migraine episodes separated by at least 48 hours of headache pain freedom
    5. Subjects with history of 2 to 8 migraine attacks per month with moderate to severe headache
    6. Subjects with no more than 15 days of headache per month
    7. Subjects on prophylactic migraine medication (no more than 1 prophylactic agent) on a stable dose for at least 3 months prior to study entry. If prophylaxis has been withdrawn, this should have been at least 1 month prior to inclusion or longer for compounds with long half-lives or that accumulate
    8. Any female subject of childbearing potential must use adequate methods of contraception throughout the course of the study.
    9. Subjects able to understand and comply with all study procedures
    10. Subjects who have signed written informed consent prior to inclusion into the study.
    Per essere ammessi a questo studio i soggetti devono soddisfare tutti i seguenti criteri:
    1. essere maschio o femmina di età compresa tra i 18 e i 65 anni;
    2. soffrire di emicrania con o senza aura, secondo i criteri ICHD-3, da almeno 1 anno e con 3 mesi di storia retrospettiva ben documentata;
    3. aver avuto un esordio dell'emicrania prima dei 50 anni di età;
    4. avere una storia di attacchi di emicrania della durata tipica compresa tra 4 e 72 ore, se non trattata o trattata senza successo, e episodi di emicrania distanziati tra loro di almeno 48 ore senza dolore da cefalea;
    5. avere una storia di 2-8 attacchi di emicrania con cefalea da moderata a grave al mese;
    6. non avere più di quindici giorni di cefalea al mese;
    7. assumere un trattamento farmacologico di profilassi per l'emicrania (con non più di un trattamento) a dose stabile da almeno 3 mesi prima dell'ingresso nello studio. Nel caso in cui la profilassi sia stata interrotta, l’interruzione dovrebbe essere avvenuta almeno 1 mese prima dell'inclusione del soggetto nello studio o da più tempo per farmaci con lunga emivita o che non vengono eliminati rapidamente;
    8. Tutti i soggetti di sesso femminile in età fertile devono utilizzare metodi di contraccezione adeguati durante tutto il corso dello studio;
    9. essere in grado di comprendere e seguire tutte le procedure dello studio;
    10. aver firmato il consenso informato scritto prima dell'inclusione nello studio.
    E.4Principal exclusion criteria
    Subjects eligible for the study must not meet any of the following criteria:
    1. Subjects with major depression, schizophrenia, dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, might interfere with study assessments
    2. Subjects with actual acute pain syndromes
    3. Subjects taking medications suspected to interfere with the IMP or known to interfere with the IMP if the pathology under treatment is unstable and if, in the Investigator’s opinion, the concurrent administration of the IMP during the study may be contraindicated
    4. Subjects with presence of anaemia
    5. Subjects with a history or evidence of asthma
    6. Subjects with uncontrolled blood hypertension with significant cardiac impairment (i.e heart failure, severe ischemic heart disease) history or cerebrovascular diseases (i.e. ictus), history of peripheral arterial disease
    7. Subjects with impaired hepatic or renal function, on the basis of out of range blood and urine analyses.
    8. Subjects with a history of congenital bleeding diathesis (e.g., haemophilia) or any active clinically significant bleeding, or have any underlying platelet dysfunction including (e.g. idiopathic thrombocytopenic purpura, disseminated intravascular coagulation, or congenital platelet dysfunction)
    9. Subjects with a history of allergy or hypersensitivity to any component of aspirin (or aspirin related products), NSAIDs, or COX-2 inhibitors
    10. Subjects administered with NSAIDs, triptans, ergotamine, opioids, or combination analgesics as medication for acute treatment of headache for 15 or more days per month in the previous month
    11. Pregnant or nursing women
    12. Subjects who have participated in an investigational drug trial in the month prior to the inclusion in the study protocol.
    NON saranno ammessi a questo studio i soggetti che:
    1. soffrono di depressione maggiore, schizofrenia, demenza o disturbi neurologici significativi (diversi dall'emicrania) in una misura che, secondo lo Sperimentatore, potrebbe interferire con le valutazioni dello studio;
    2. hanno sindromi dolorose acute al momento della valutazione;
    3. assumono farmaci sospettati di interferire con l'IMP (il medicinale sperimentale) o con nota capacità di interferire con l'IMP se la patologia trattata è instabile e se, secondo lo Sperimentatore, la somministrazione contemporanea dell'IMP durante lo studio potrebbe essere controindicata;
    4. sono affetti da anemia;
    5. hanno una storia o evidenza di asma;
    6. soffrono di ipertensione arteriosa non controllata con compromissione cardiaca significativa (ad es. insufficienza cardiaca, grave cardiopatia ischemica), storia di malattie cerebrovascolari (ad es. ictus), storia di arteriopatia periferica;
    7. hanno una funzionalità epatica o renale compromessa, valutata in base ad analisi del sangue e dell'urina con risultati fuori dai valori normali;
    8. hanno una storia di diatesi emorragica congenita (ad es. emofilia) o altro sanguinamento attivo clinicamente significativo, o con una qualsiasi disfunzione piastrinica latente (tra cui porpora trombocitopenica idiopatica, coagulazione intravascolare disseminata o disfunzione piastrinica congenita);
    9. hanno una storia di allergia o ipersensibilità ad un qualsiasi componente dell'aspirina (o prodotti correlati), FANS o inibitori selettivi della COX-2;
    10. hanno assunto una terapia con FANS, triptani, ergotamina, oppioidi o una combinazione di analgesici come trattamento acuto della cefalea per 15 o più giorni al mese nel mese precedente;
    11. sono donne in gravidanza o in allattamento;
    12. hanno partecipato ad uno studio clinico con farmaco, nel mese precedente l'inclusione nel protocollo di studio.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of subjects pain free (pain score = zero) at 2 hours after the study drug injection.
    La percentuale di soggetti con assenza di dolore (punteggio del dolore = zero) a 2 ore dall'iniezione con il farmaco sperimentale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of study.
    Fine studio.
    E.5.2Secondary end point(s)
    Percentage of subjects with the absence of photophobia at 2 hours after the injection using a binary scale (present or absent).; Percentage of subjects with the absence of phonophobia at 2 hours after the injection using a binary scale (present or absent).; Percentage of subjects with absence of nausea at 2 hours after the injection using a binary scale (present or absent).; Percentage of subjects with absence of vomit at 2 hours after the injection using a binary scale (present or absent).; Percentage of subjects with absence of nausea at 12, 24 and 48 hours after the injection.; Percentage of subjects with sustained pain freedom from 2 to 24 hours after the injection.; Percentage of subjects with sustained pain freedom from 2 to 48 hours after the injection; The incidence of relapse, defined as the return of headache of any severity within 48 hours after the injection when the subjects was pain-free at 2 hours after the injection.; Percentage of subjects requiring Rescue Medication within 48 after administration of study medication.; Percentage of subjects able to function normally, at 2 hours, defined as “no impact” of migraine on the daily activities, using a 4-point Likert-like Scale: severe (score=3), moderate (score=2), mild (score=1), none (score=0); Percentage of subjects satisfied or extremely satisfied at 2 hours after initial treatment using a 5-Point Likert-like Scale:
    totally satisfied (score=4), satisfied (score=3), neither satisfied nor unsatisfied (score=2), unsatisfied (score=1), totally unsatisfied (score=0); Time to pain freedom, evaluated as the speed of onset of therapeutic effect.; Subject’s Global Impression of the study treatment using a 5-Point Likert-like Scale evaluated at the end of the migraine attack:
    excellent (score=4) ,good (score=3), fair (score=2), poor (score=1), very poor (score=0)
    La percentuale di soggetti con assenza di fotofobia 2 ore dopo l'iniezione su una scala binaria (presente o assente);; La percentuale di soggetti con assenza di fonofobia 2 ore dopo l'iniezione su una scala binaria (presente o assente).; La percentuale di soggetti con assenza di nausea 2 ore dopo l'iniezione su una scala binaria (presente o assente).; La percentuale di soggetti con assenza di vomito 2 ore dopo l'iniezione su una scala binaria (presente o assente).; La percentuale di soggetti con assenza di nausea a 12, 24 e 48 ore dall'iniezione.; La percentuale di soggetti con assenza di dolore prolungata a 2-24 ore dall'iniezione.; La percentuale di soggetti con assenza di dolore prolungata a 2-48 ore dall'iniezione.; L'incidenza di recidive, ossia il ritorno di cefalea di qualsiasi livello di gravità entro 48 ore dall'iniezione dopo che i soggetti sono stati privi di dolore a 2 ore dall'iniezione.; La percentuale di soggetti che necessitano di farmaci di soccorso entro 48 dalla somministrazione del farmaco sperimentale.; La percentuale di soggetti in grado di agire normalmente a 2 ore, ossia con un "impatto nullo" dell'emicrania sulle attività quotidiane, su una scala tipo Likert a 4 punti: forte (punteggio = 3), moderato (punteggio = 2), leggero (punteggio = 1), nessuno (punteggio = 0).; La percentuale di soggetti soddisfatti o molto soddisfatti 2 ore dopo il trattamento iniziale su una scala tipo Likert a 5 punti: totalmente soddisfatto (punteggio = 4), soddisfatto (punteggio = 3), né soddisfatto né insoddisfatto (punteggio = 2), insoddisfatto (punteggio = 1), totalmente insoddisfatto (punteggio = 0).; Il tempo impiegato per arrivare all'assenza di dolore valutato come velocità dell'esordio dell'effetto terapeutico; L'impressione complessiva del soggetto sul farmaco sperimentale su una scala tipo Likert a 5 punti valutata alla fine di un attacco di emicrania: eccellente (punteggio = 4), buona (punteggio = 3), discreta (punteggio = 2), scarsa (punteggio = 1), pessima (punteggio = 0).
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of study.; End of study.; End of study.; End of study.; End of study.; End of study.; End of study.; End of study.; End of study.; End of study.; End of study.; End of study.; End of study.
    Fine studio.; Fine studio.; Fine studio.; Fine studio.; Fine studio.; Fine studio.; Fine studio.; Fine studio.; Fine studio.; Fine studio.; Fine studio.; Fine studio.; Fine studio.
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability.
    Tollerabilità.
    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 trial4
    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 concerned10
    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 years0
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months11
    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: 128
    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 state128
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 128
    F.4.2.2In the whole clinical trial 128
    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)
    \
    \
    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 Decision2018-07-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-22
    P. End of Trial
    P.End of Trial StatusCompleted
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