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    Summary
    EudraCT Number:2018-002233-37
    Sponsor's Protocol Code Number:IPX203-B16-02
    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:2021-01-07
    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 number2018-002233-37
    A.3Full title of the trial
    A randomized controlled study to compare the safety and efficacy of IPX203 with immediate-release carbidopa-levodopa in Parkinson's disease patients with motor fluctuations.
    Studio randomizzato controllato per confrontare la sicurezza e l’efficacia di IPX203 con carbidopa-levodopa a rilascio immediato in pazienti affetti da malattia di Parkinson con fluttuazioni motorie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluate the safety and efficacy of IPX203 carbidopa-levodopa extended release capsules compared to carbidopa-levodopa immediate release tablets in patients with Parkinson's with motor fluctuations.
    Valutare la sicurezza e l'efficacia di capsule a rilascio prolungato di carbidopa-levodopa confronto a compresse a rilascio immediato di carbidopa-levodopa in pazienti affetti da malattia di Parkinson con fluttuazioni motorie
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberIPX203-B16-02
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03670953
    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 SponsorImpax Laboratories, LLC
    B.1.3.4CountryUnited States
    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 supportImpax Laboratories, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationImpax Laboratories, LLC
    B.5.2Functional name of contact pointDrug Safety Dept. Attn: Dr. Sanwo
    B.5.3 Address:
    B.5.3.1Street Address50 Horse Block Road
    B.5.3.2Town/ cityBrookhaven, NY
    B.5.3.3Post code11719
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018778355472
    B.5.5Fax number0016319245145
    B.5.6E-mailDrugSafety@Amneal.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 nameIPX203
    D.3.2Product code [IPX203]
    D.3.4Pharmaceutical form Modified-release 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 INNLEVODOPA
    D.3.9.1CAS number 59-92-7
    D.3.9.2Current sponsor codeLD
    D.3.9.3Other descriptive nameLEVODOPA
    D.3.9.4EV Substance CodeSUB08468MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCARBIDOPA
    D.3.9.2Current sponsor codeCD
    D.3.9.3Other descriptive nameANHYDROUS CARBIDOPA
    D.3.9.4EV Substance CodeSUB22639
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number35
    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 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 Carbidopa and Levodopa Tablets, USP
    D.2.1.1.2Name of the Marketing Authorisation holderMylan Pharmaceuticals Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameIR CD-LD (carbidopa-levodopa) tablets
    D.3.2Product code [IR CD-LD]
    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 INNLEVODOPA
    D.3.9.1CAS number 59-92-7
    D.3.9.2Current sponsor codeLD
    D.3.9.4EV Substance CodeSUB08468MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCARBIDOPA
    D.3.9.2Current sponsor codeCD
    D.3.9.3Other descriptive nameANHYDROUS CARBIDOPA
    D.3.9.4EV Substance CodeSUB22639
    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.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
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    Parkinson's disease
    Malattia di Parkinson
    E.1.1.1Medical condition in easily understood language
    Parkinson's disease
    Malattia di Parkinson
    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 10061536
    E.1.2Term Parkinson's disease
    E.1.2System Organ Class 10029205 - Nervous system disorders
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10028035
    E.1.2Term Movement disorder
    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 safety and efficacy of IPX203 in comparison to IR CD-LD in the treatment of CD-LD-experienced subjects with Parkinson's disease who have motor fluctuations.
    Valutare la sicurezza e l’efficacia di IPX203 rispetto a CD-LD a rilascio immediato (IR) nel trattamento di soggetti affetti da malattia di Parkinson (MP) precedentemente esposti a CD-LD che presentano fluttuazioni motorie
    E.2.2Secondary objectives of the trial
    NA
    NA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female subjects diagnosed at age = 40 years with PD, consistent with the United Kingdom Parkinson’s Disease Society Brain Bank Diagnostic Criteria and who are being treated with stable regimens of CD-LD but experiencing motor fluctuations.
    • Hoehn and Yahr Stages 1, 2, 3, or 4 in the “On” state (part of Movement Disorders Society version of the Unified Parkinson’s Disease Rating Scale [MDS-UPDRS] Part III)
    • Montreal Cognitive Assessment (MoCA) score = 24 at Screening Visit in “On” state.
    • By history, for the 4 weeks prior to Screening, the subject experiences daily “wearing-off” episodes with periods of bradykinesia in combination with at least one of rest tremor or rigidity, experiences an “Off” state upon awakening on most mornings, and reports an average of at least 2.5 cumulative hours per day of “Off” time during the waking hours.
    • Able to differentiate “On” state from “Off” state as determined by at least 75% concordance with a trained rater in “On/Off” ratings for 8 ratings over a 4-hour training period. The concordance must include at least 1 “On” and 1 “Off” rating and must be achieved within two 4 hour training sessions.
    • At Visit 1, review of the 3-day PD Diaries confirms the following: that the subject is able to properly complete the Diaries with valid entries; and that the subject has an Uaverage of at least 2.5 hoursU per day of “Off” time during waking hours over the 3 days with at least 1.5 hours of cumulative “Off” time on each day.
    • Responsive to CD LD therapy and currently being treated on a stable regimen with CD LD for at least 4 weeks prior to Visit 1 and:
    - Requires at least 100 mg of LD from IR CD LD for the first morning dose
    - Requires a total daily dose of at least 400 mg of LD and takes a maximum total daily dose of 2400 mg LD, from IR CD LD alone or IR CD LD in combination with a single daily bedtime dose of CR CD LD
    - Has a dosing frequency of 4 to 9 times daily of CD-LD
    - By history, typically experiences an “On” response with the first dose of IR CD LD of the day, but the efficacy of this dose typically lasts less than 4 hours.
    • At Screening, the subject has predictable “Off” periods defined by a score of 1 or 2 on Item #4.5 (Complexity of Motor Fluctuations) of the MDS-UPDRS Part IV B (Motor Fluctuations).
    • At Screening, the MDS-UPDRS Part III total score in the “Off” state is at least 20 units.
    • Soggetti di ambo i sessi con diagnosi di MP ricevuta a un’età =40 anni, coerentemente con i Criteri diagnostici della banca cerebrale della Società per la malattia di Parkinson del Regno Unito e in fase di trattamento con regimi stabili di CD-LD pur manifestando fluttuazioni motorie.
    • Stadi Hoehn e Yahr pari a 1, 2, 3 o 4 nello stato “On” (parte della versione della Società per i disturbi del movimento della Scala di valutazione unificata della malattia di Parkinson [MDS-UPDRS] Parte III).
    • Punteggio della Valutazione cognitiva di Montreal (MoCA) =24 alla visita di screening nello stato “On”.
    • In base all’anamnesi, nelle 4 settimane precedenti lo screening, il soggetto manifesta episodi giornalieri di “deterioramento da fine dose” con periodi di discinesia in combinazione con almeno uno di tremore o rigidità a riposto, manifesta uno stato “On” al risveglio quasi tutte le mattine e riferisce una media di almeno 2,5 ore cumulative al giorno di tempo “Off” durante le ore di veglia.
    • Il soggetto è in grado di distinguere tra stato “On” e stato “Off” come determinato da una concordanza di almeno il 75% con un valutatore esperto in valutazioni dello stato “On/Off” per 8 valutazioni nell’arco di un periodo di formazione di 4 ore. La concordanza deve includere almeno 1 valutazione “On” e 1 “Off” e deve essere raggiunta entro due sessioni formative di 4 ore.
    • Alla Visita 1, la revisione dei diari sulla MP di 3 giorni conferma quanto segue: che il soggetto è in grado di compilare correttamente i diari con informazioni valide e che il soggetto presenta una media di almeno 2,5 oreU al giorno di tempo “Off” durante le ore di veglia nell’arco di 3 giorni con almeno 1,5 ore di tempo “Off” cumulativo ogni giorno.
    • Il soggetto è responsivo alla terapia con CD-LD e attualmente è in fase di trattamento con un regime stabile a base di CD-LD da almeno 4 settimane prima della Visita 1 e:
    - necessita di almeno 100 mg di LD da CD-LD IR per la prima dose mattutina;
    - necessita di una dose giornaliera totale di almeno 400 mg di LD e assume una dose massima giornaliera totale di 2.400 mg di LD, da CD-LD IR in monoterapia o CD-LD IR in combinazione con una dose singola serale giornaliera di CD-LD;
    - assume CD-LD con una frequenza di somministrazione di 4-9 volte al giorno;
    - in base all’anamnesi, manifesta generalmente una risposta “On” con la prima dose di CD-LD IR del giorno, ma l’efficacia di questa dose solitamente dura meno di 4 ore.
    • Allo screening, il soggetto presenta periodi “Off” prevedibili definiti da un punteggio di 1 o 2 alla Voce n. 4.5 (Complessità delle fluttuazioni motorie) della scala MDS-UPDRS Parte IV B (Fluttuazioni motorie).
    • Allo screening, il punteggio totale della scala MDS-UPDRS Parte III nello stato “Off” è pari ad almeno 20 unità.
    E.4Principal exclusion criteria
    • Used any doses of controlled-release (CR) CD-LD apart from a single daily bedtime dose within 4 weeks prior to Visit 1.
    • Used any dose of Rytary for the past 4 weeks prior to Visit 1 or were considered IPX066 or Rytary failures for reasons of efficacy or safety.
    • Had prior neurosurgical treatment for PD or if such procedure is planned or anticipated during the study period.
    • Allergic to any excipient in the study drugs.
    • History of glaucoma with intraocular pressures that are elevated despite appropriate medical management.
    • History of seizure or epilepsy and experienced at least 1 seizure during the past 12 months or has not been compliant with medically recommended therapy or visits.
    • History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias that are not controlled with medical and/or surgical interventions. A recent (= 12 months) history of myocardial infarction with secondary arrhythmias is exclusionary regardless of the therapeutic control.
    • Received within 4 weeks of Screening or planning to take during participation in the clinical study:
    - Any doses of a CR CD-LD apart from a single daily bedtime dose, any doses of Rytary, additional CD (eg, Lodosyn) or benserazide (eg, Serazide), or catechol-O-methyl transferase inhibitors (entacapone or tolcapone) or medications containing these inhibitors (Stalevo),
    - Nonselective monoamine oxidase inhibitors (MAOI), apomorphine, or antidopaminergic agents, including antiemetics.
    • Subjects who have previously participated in an IPX203 study.
    • Precedente utilizzo di qualsiasi dose di CD-LD a rilascio controllato (CR) ad eccezione di una singola dose serale giornaliera nelle 4 settimane precedenti la Visita 1.
    • Precedente utilizzo di Rytary nelle ultime 4 settimane precedenti la Visita 1 o mancata risposta a IPX066 o Rytary per motivi di efficacia o sicurezza.
    • Precedente trattamento chirurgico per MP o procedura analoga programmata o prevista durante il periodo di studio.
    • Allergia a qualsiasi eccipiente contenuto nei farmaci dello studio.
    • Anamnesi di glaucoma con pressioni intraoculari elevate nonostante un’appropriata gestione medica.
    • Anamnesi di crisi convulsive o epilessia e precedente episodio almeno 1 crisi convulsiva durante gli ultimi 12 mesi oppure mancata conformità alla terapia o alle visite clinicamente raccomandate.
    • Anamnesi di infarto miocardico con aritmie atriali, nodali o ventricolari residue che non sono controllate con interventi medici e/o chirurgici. Una recente anamnesi (=12 mesi) di infarto miocardico con aritmie secondarie comporta l’esclusione indipendentemente dal controllo terapeutico.
    • Precedente assunzione nelle 4 settimane precedenti lo screening o assunzione prevista durante la partecipazione allo studio clinico di:
    - qualsiasi dose di una CD-LD CR ad eccezione di una singola dose serale giornaliera, qualsiasi dose di Rytary, CD aggiuntiva (es. Lodosyn) o benserazide (es. Serazide), oppure inibitori della catecol-O-metil transferasi (entacapone o tolcapone) o farmaci contenenti questi inibitori (Stalevo);
    - inibitori non selettivi delle monoamino ossidasi (MAOI), apomorfina o agenti antidopaminergici, inclusi gli antiemetici.
    • Soggetti che in precedenza hanno partecipato a uno studio di IPX203.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in “Good on” time in hours per day, averaged over the PD Diary days, at the end of double-blind treatment period (Visit 7 or early termination). “Good on” time is derived from the 3-day PD Diaries and is defined as the sum of “On” time without dyskinesia and “On” time with nontroublesome dyskinesia.
    Variazione rispetto al basale nel tempo “Good on” in ore al giorno, calcolato come media rispetto ai giorni del diario sulla MP, alla fine del periodo di trattamento in doppio cieco (Visita 7 o interruzione anticipata). Il tempo “Good on” è ricavato dai diari di 3 giorni sulla MP ed è definito come la somma del tempo “On” senza discinesia e del tempo “On” con discinesia non fastidiosa.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 7 or early termination
    Visita 7 o interruzione anticipata
    E.5.2Secondary end point(s)
    - Change from baseline in “Off” time in hours per day, averaged over the PD Diary days at the end of double-blind treatment period (Visit 7 or early termination)
    - Proportion of subjects with either “much improved” or “very much improved” in Patient Global Impression of Change (PGI-C) scores at the end of double-blind treatment period (Visit 7 or early termination)
    - Change from baseline in the MDS-UPDRS Part III at the end of double-blind treatment period (Visit 7 or early termination)
    - Change from baseline in the sum of MDS-UPDRS Parts II and III at the end of double-blind treatment period
    - Variazione rispetto al basale nel tempo “Off” in ore al giorno, calcolato come media rispetto ai giorni del diario sulla MP, alla fine del periodo di trattamento in doppio cieco (Visita 7 o interruzione anticipata)
    - percentuale di soggetti con valutazione “molto migliorato” o “estremamente migliorato” nei punteggi dell’Impressione globale del paziente sul cambiamento (PGI-C) alla fine del periodo di trattamento in doppio cieco (Visita 7 o interruzione anticipata)
    - Variazione rispetto al basale nella scala MDS-UPDRS Parte III alla fine del periodo di trattamento in doppio cieco (Visita 7 o interruzione anticipata)
    - Variazione rispetto al basale nella somma delle Parti II e III della scala MDS-UPDRS alla fine del periodo di trattamento in doppio cieco (Visita 7 o interruzione anticipata)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visit 7 or early termination
    Visita 7 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 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) 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 Yes
    E.8.1.7.1Other trial design description
    double-dummy
    double-dummy
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA52
    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
    Czechia
    France
    Germany
    Italy
    Spain
    United Kingdom
    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 years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days16
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days16
    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: 265
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 245
    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 state56
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 266
    F.4.2.2In the whole clinical trial 510
    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)
    Open label extension study planned for subjects who completed this main IPX203-B16-02 study
    studio di estensione open label per i soggetti che hanno completato lo studio principale IPX203-B16-02
    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 Decision2019-05-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-13
    P. End of Trial
    P.End of Trial StatusCompleted
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