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    Summary
    EudraCT Number:2010-021291-29
    Sponsor's Protocol Code Number:FOV2304/CLIN/201/P
    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:2012-03-29
    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 number2010-021291-29
    A.3Full title of the trial
    A 6-month, Phase II, Double-masked, Multicenter, Randomized, Placebo controlled, Parallel Group Study to Assess the Safety and Efficacy of Topical Administration of Two Concentrations of FOV2304 (1% and 2%) Twice Daily for the Treatment of Center-involving Clinically Significant Macular Edema Associated with Diabetic Retinopathy
    A 6-month, Phase II, Double-masked, Multicenter, Randomized, Placebo controlled, Parallel Group Study to Assess the Safety and Efficacy of Topical Administration of Two Concentrations of FOV2304 (1% and 2%) Twice Daily for the Treatment of Center-involving Clinically Significant Macular Edema Associated with Diabetic Retinopathy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to compare the safety and effectiveness of two concentrations of FOV2304 to placebo in the treatment of diabetic macular edema
    Uno studio teso a confrontare la sicurezza e l’efficacia di due concentrazioni di FOV2304 rispetto al placebo nel trattamento dell`Edema maculare diabetico
    A.4.1Sponsor's protocol code numberFOV2304/CLIN/201/P
    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 SponsorFOVEA 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 supportFOVEA PHARMACEUTICALS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFOVEA PHARMACEUTICALS
    B.5.2Functional name of contact point.
    B.5.3 Address:
    B.5.3.1Street Address17 RUE MOREAU
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75012
    B.5.3.4CountryItaly
    B.5.4Telephone numberna
    B.5.5Fax numberna
    B.5.6E-mailxx@xxx.xx
    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 nameFOV2304/SOL2/1%
    D.3.2Product code FOV2304/SOL2/1%
    D.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOther ophthalmologicals
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeFV-60135-02
    D.3.9.3Other descriptive nameNA
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.3Concentration number1
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product 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 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 nameFOV2304/SOL2/2%
    D.3.2Product code FOV2304/SOL2/2%
    D.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOTHER OPHTHALMOLOGICALS
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeFV-60135-02
    D.3.9.3Other descriptive nameNA
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.3Concentration number2
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product 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 placeboEye drops, solution
    D.8.4Route of administration of the placeboOcular use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboEye drops, solution
    D.8.4Route of administration of the placeboOcular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Clinically significant diabetic macular edema in at least one eye involving the center of the macula
    Edema maculare diabetico clinicamente significativo che coinvolge il centro della retina in almeno un occhio
    E.1.1.1Medical condition in easily understood language
    diabetic macular edema
    Edema maculare diabetico .
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10057934
    E.1.2Term Diabetic macular edema
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to determine whether concentrations of FOV2304 at 1% BID or 2% BID is more effective than placebo in decreasing mean central retinal thickness following twelve weeks of treatment for patients with DME
    L`obiettivo primario dello studio e` determinare se il FOV2304 all’1% BID o al 2% BID siano piu` efficaci del placebo nel ridurre lo spessore medio centrale della retina dopo un trattamento di 12 settimane in pazienti affetti da DME.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to estimate the effects of FOV2304 (1% and 2% BID) compared with placebo on visual acuity, retinal thickness and macular volume following twelve weeks treatment and after a further twelve weeks of follow-up, the requirement for rescue therapy during the safety follow-up period and to assess the safety, tolerability, and PK of FOV2304 in the treatment of patients with DME.
    Gli obiettivi secondari dello studio sono: -valutare gli effetti di FOV2304 (all’1% e al 2% BID) rispetto al placebo sull`acuita` visiva, sullo spessore della retina e sul volume maculare dopo 12 settimane di trattamento e dopo un periodo di follow-up di ulteriori 12 settimane. - determinare la necessita` della terapia di soccorso durante il periodo di follow-up di sicurezza. -valutare la sicurezza, la tollerabilita` ed i parametri farmacocinetici (PK) di FOV2304 nel trattamento di pazienti affetti da DME.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, at least 18 years of age 2. Written, signed informed consent obtained 3. Diagnosis of diabetes mellitus 4. Patient must be able to self administer study drug. 5. Clinically significant diabetic macular edema in at least one eye (“study eye”) involving the center of the macula. 6. Mild to severe non proliferative diabetic retinopathy 7. BCVA score ≥34 letters and < 80 letters in the study eye 8. Female patients at least 1 year postmenopausal, surgically sterile or practicing two medically acceptable method of contraception. Women of childbearing potential must have a negative urine pregnancy test at Screening and be using two highly effective methods of contraception throughout the study. 9. Male patients with partners of childbearing potential must agree to use at least one highly effective method of contraception throughout the study.
    1) Pazienti di sesso maschile o femminile con eta` minima di 18 anni. 2)Pazienti che hanno firmato e dato il consenso informato scritto. 3)Diagnosi di diabete mellito 4) Pazienti in grado di auto-somministrarsi il farmaco dello studio. 5) Presenza di edema maculare diabetico clinicamente significativo ad almeno un occhio (``l`occhio dello studio``) che coinvolge il centro della macula. 6)Retinopatia diabetica non proliferativa da moderata a grave 7) Punteggio della miglior acuita` visiva corretta (BCVA) ≥ 34 lettere e &lt; 80 lettere nell`occhio dello studio 8)Pazienti donne in menopausa da almeno un anno o sterilizzate chirurgicamente oppure che utilizzano due metodi di contraccezione accettabile dal punto di vista medico. Al momento dello screening, le donne potenzialmente fertili devono essere sottoposte a un test di gravidanza sulle urine (su striscia) con risultato negativo e devono usare due metodi di contraccezione altamente efficaci durante l`intera durata dello studio. 9) I pazienti maschi con partner potenzialmente fertili devono accettare di utilizzare almeno un metodo di contraccezione altamente efficace per tutta la durata dello studio.
    E.4Principal exclusion criteria
    1. Any ocular condition in the study eye that in the opinion of the investigator would prevent improvement in visual acuity (including but not limited to severe macular ischemia, foveal atrophy, pigmentary changes, dense subfoveal hard exudates, nonretinal condition) 2. Proliferative diabetic retinopathy in the study eye 3. History of panretinal scatter photocoagulation (PRP) in the study eye within 4 months prior to screening, and/or anticipated need for PRP in the 3 months following randomization 4. Presence of any other condition in the study eye which could be contributing to macular edema: a. Presence of branch retinal vein occlusion, central retinal vein occlusion, uveitis, pseudophakic cystoid macular edema or any other condition in the study eye which could be contributing to macular edema b. Presence of an epiretinal membrane, posterior hyaloidal traction, or vitreomacular traction in the study eye which, in the opinion of the investigator or central reading center, is the primary cause of macular edema, or is severe enough to prevent improvement in visual acuity despite reduction in macular edema. 5. Active optic disc or retinal neovascularization, rubeosis iridis, active or history of choroidal neovascularization in the study eye. 6. History of pars plana vitrectomy at any time, intraocular surgery in the study eye within 90 days prior to screening 7.History of use of intravitreal injectable or periocular depot corticosteroids (other than triamcinolone acetonide) within 3 months prior to the screening visit in the study eye. 8. Patients who have previously received triamcinolone acetonide in the study eye. 9. Patients who have previously received anti-vascular endothelial growth factor (VEGF) therapy: a) Intravitreal anti-VEGF in the study eye within 3 months prior to the screening visit and/or b) Systemically within 3 months prior to the screening visit. 10. Uncontrolled glaucoma or glaucoma treated by 2 or more medications 11. Aphakia or intraocular lens placement in the anterior chamber of the study eye 12. Intraocular pressure (IOP) ≥ 25 mmHg in the study eye on aplanation tonometry at screening visit. 13. Patients whose cumulative baseline corneal fluorescein staining score (i.e. sum of scores for all 5 corneal regions) for the study eye is graded as ≥5, or whose baseline corneal fluorescein staining score in any single region for the study eye is graded as ≥3 14. Any active ocular infection; any history of recurrent or chronic infection or inflammation in the study eye 15. History of herpetic infection in either eye 16. History of corneal pathology/surgery 17. Contact lens use at any time during the study. Systemic conditions: 18. Uncontrolled systemic disease 19. Poorly controlled diabetes mellitus 20. Impaired renal function 21. Initiation/change of medical therapy for diabetes mellitus or hypertension within 4 months prior to screening, or planned change in the 4 months following inclusion in the study 22. Poorly controlled arterial hypertension 23. Use of systemic steroids within 1 month prior to the screening visit or anticipated use at any time during the study. 24.Concurrent participation in another clinical trial or treatment with any IMP within 3 months prior to inclusion in the study
    1. Qualunque condizione oculare a carico dell`occhio dello studio che, a giudizio dell`investigatore, potrebbe prevenire un potenziale miglioramento dell`acuita` visiva (compreso ma non limitato a ischemia maculare grave, atrofia della fovea, alterazioni pigmentarie, presenza di essudati subfoveali densi e duri, condizione non retinica). 2. Retinopatia diabetica proliferativa nell`occhio dello studio. 3. Anamnesi di fotocoagulazione panretinica (PRP) nell`occhio dello studio nei 4 mesi che precedono lo screening, e/o necessita` di PRP nei 3 mesi che seguono la randomizzazione. 4. Presenza di altre condizioni nell`occhio dello studio che potrebbero contribuire all`edema maculare: a. occlusione di una branca della vena retinica, occlusione della vena retinica centrale, uveite, edema maculare cistoide pseudofachico o esistenza di qualunque altra condizione che potrebbe contribuire all`edema maculare a carico dell`occhio dello studio. b. presenza di una membrana epiretinica, trazione della ialoidea posteriore o trazione vitreo-maculare nell`occhio dello studio che, a giudizio dell`investigatore o del centro di lettura centrale, costituisce la causa primaria dell`edema maculare o e` sufficientemente grave da impedire il miglioramento dell`acuita` visiva, nonostante la riduzione dell`edema maculare. 5. Disco ottico attivo o neovascolarizzazione retinica,rubeosis iridis,neovascolarizzazione coroideale attiva o pregressa nell`occhio dello studio. 6. Anamnesi di vitrectomia via pars plana, intervento di chirurgia intraoculare nell`occhio dello studio nei 90 giorni prima dello screening. 7.Precedente utilizzo nell`occhio dello studio di corticosteroidi intravitreali iniettabili o depot perioculari (diversi dal triamcinolone acetonide) nei 3 mesi prima della visita di screening. 8. Pazienti che in passato sono stati trattati con triamcinolone acetonide nell`occhio dello studio. 9. Pazienti precedentemente trattati con terapia anti fattore di crescita dell`endotelio vascolare (VEGF): a) anti-VEGF intravitreale nell`occhio dello studio nei 3 mesi prima della visita di screening e/o b) trattamento sistemico nei 3 mesi prima della visita di screening. 10. Presenza di glaucoma non controllato o glaucoma trattato con 2 o piu` farmaci. 11. Afachia o presenza di lente intraoculare in camera anteriore nell`occhio dello studio. 12. Pressione intraoculare (IOP) ≥ 25 mmHg nell`occhio dello studio misurata con la tonometria ad applanazione, alla visita di screening; 13.Pazienti con un punteggio cumulativo della colorazione della cornea con fluoresceina (cioe`, la somma dei punteggi di tutte e 5 le regioni corneali), misurato alla visita iniziale, per l`occhio dello studio ≥ 5 oppure con un punteggio di colorazione della cornea con fluoresceina, misurato alla visita iniziale, ≥ 3 per ogni singola regione dell`occhio dello studio. 14.Infezione oculare in atto; anamnesi di infezioni o infiammazioni ricorrenti o croniche a carico dell`occhio dello studio. 15. Anamnesi di infezione erpetica in uno o in entrambi gli occhi 16. Anamnesi di patologia/chirurgia della cornea 17.Uso di lenti a contatto in qualunque momento durante lo studio. Condizioni sistemiche: 18. Patologia sistemica non controllata. 19. Diabete mellito scarsamente controllato. 20.Ridotta funzionalita` renale. 21.Inizio/variazione della terapia per il diabete mellito o l`ipertensione nei 4 mesi che precedono lo screening, o modifica programmata entro i 4 mesi successivi all`inclusione del paziente nello studio. 22.Ipertensione arteriosa scarsamente controllata 23. Uso di steroidi sistemici nel mese precedente alla visita di screening o intenzione di utilizzare steroidi sistemici durante lo studio. 24. Partecipazione concomitante a un`altra sperimentazione clinica o trattamento con qualsiasi IMP nei 3 mesi precedenti l`inclusione nello studio
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the change from baseline of CRT (central retinal thickness) as determined by logOCT (optical coherence tomography) following up to 12 weeks of treatment.
    L’endpoint primario di questo studio e' valutare la variazione del CRT dalla baseline, determinato tramite logOCT dopo un massimo di 12 settimane di trattamento
    E.5.1.1Timepoint(s) of evaluation of this end point
    The change from baseline of CRT (central retinal thickness) will be examined over the 12 week treatment period
    La variazione dalla baseline del CRT (spessore centrale della retina) sara' esaminato durante le 12 settimane del periodo di trattamento
    E.5.2Secondary end point(s)
    - Proportion of patients with an improvement in BCVA (best corrected visual acuity). - Change in macular volume edema
    - Percentuale di pazienti che mostrano miglioramenti nel BCVA - Cambiamento del volume dell`edema maculare
    E.5.2.1Timepoint(s) of evaluation of this end point
    Following up to 12 and 24 weeks of treatment
    Following up to 12 and 24 weeks of treatment
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    European Union
    Australia
    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 years0
    E.8.9.1In the Member State concerned months14
    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 months14
    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.1.1Number of subjects for this age range: 0
    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: 78
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 183
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 261
    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)
    NA
    NA
    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 Decision2011-04-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-09-17
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