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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 22 December 2015
Main ID:  EUCTR2012-000835-18-IT
Date of registration: 19/12/2012
Prospective Registration: Yes
Primary sponsor: NOVARTIS FARMA
Public title: A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS
Scientific title: Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis
Date of first enrolment: 12/01/2013
Target sample size: 750
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-000835-18
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other: Number of treatment arms in the trial: 1  
Phase: 
Countries of recruitment
Australia Belgium Canada Czech Republic Denmark Finland Germany Hungary
Italy Netherlands Poland Spain Sweden Switzerland Turkey United Kingdom
United States
Contacts
Name: Drug Regulatory Affairs   
Address:  Largo Umberto Boccioni, 1 21040 Origgio Italy
Telephone: +39 02 96541
Email: info.studiclinici@novartis.com
Affiliation:  Novartis Farma
Name: Drug Regulatory Affairs   
Address:  Largo Umberto Boccioni, 1 21040 Origgio Italy
Telephone: +39 02 96541
Email: info.studiclinici@novartis.com
Affiliation:  Novartis Farma
Key inclusion & exclusion criteria
Inclusion criteria:
Patients eligible for inclusion in this study have to fulfill all of the following criteria: Patients who have provided written informed consent Patients initially randomized to fingolimod 1.25 mg or placebo as part of the first study cohort, who have completed at least 3 years on study drug treatment at the time of extension study initiation Patients initially randomized to fingolimod 0.5 mg or placebo as part of the second study cohort who have continued on study drug treatment until such time as the last ongoing patient enrolled in the study has reached 3 years in study.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 750
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Patients who meet any of the following exclusion criteria at the baseline visit will not be eligible for enrollment in the extension study: 1. active chronic disease (or stable but treated with immune therapy) of the immune system other than MS (e.g., rheumatoid arthritis, scleroderma, Sjogren's syndrome, Crohn's disease, ulcerative colitis) or with a known immunodeficiency syndrome (HIV-antibody positive, AIDS, hereditary immune deficiency, drug-induced immune deficiency) 2. active systemic bacterial, viral or fungal infections 3. uncontrolled diabetes mellitus (HbA1c>7%) 4. positive screening for serological markers for hepatitis A, B, C, and E indicating acute or chronic infection: • anti-hepatitis A virus IgM, • hepatitis B surface antigen and/or anti-hepatitis B core antigen IgM, • anti-hepatitis C virus IgG or IgM, • anti-hepatitis E virus IgM (positive IgG: do hepatitis E virus-RNA polymerase chain reaction; if negative, patient can be included) Note: The following patients, assuming they have normal aminotransferase activities, can be included in the trial: • those testing positive for hepatitis B surface antibody, indicating hepatitis B immunization -OR- • those testing positive for anti-hepatitis B core antigen IgG, indicating a cured hepatitis B -OR- • those testing positive for anti-hepatitis A virus IgG, indicating a cured hepatitis A 5. macular edema at baseline 6. treatment with Class Ia or III antiarrhythmic drugs (e.g. amiodarone, bretylium, sotalol, ibulitide, azimilide, dofelitide) 7. any of the following cardiovascular conditions: • myocardial infarction within the past 6 months prior to enrollment or current unstable ischemic heart disease • cardiac failure at time of Screening (Class III, according to NYHA Classification; Appendix 2) or any severe cardiac disease as determined by the investigator • second degree AV block Mobitz type II or a third degree AV block on screening ECG • an increased QTc (Fridericia and Bazett) interval >500 ms on Screening ECG • hypertension, uncontrolled by medication 8. any of the following pulmonary conditions: • severe respiratory disease or pulmonary fibrosis • active tuberculosis • reduction of FEV1, FVC and/or DLCO below 60% of core study baseline values or if FEV1, FVC and/or DLCO at extension study baseline is the second of two consecutive pulmonary function tests with values <80% of core study baseline 9. any of the following hepatic conditions: • total or conjugated bilirubin greater than the upper limit of the normal range, unless in context of Gilbert's syndrome • two consecutive alkaline phosphatase (AP) values greater than 3 times the upper limit of the normal range • two consecutive AST (SGOT), ALT (SGPT) values greater than 3 times the upper limit of the normal range • two consecutive gamma-glutamyl-transferase (GGT) values greater than 3 times the upper limit of the normal range 10. any medically unstable condition, as assessed by the primary treating physician PLS SEE PROTOCOL


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Primary progressive multiple sclerosis.
MedDRA version: 14.1 Level: PT Classification code 10063401 Term: Primary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intervention(s)

Product Name: Fingolimod
Product Code: FTY720D
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: FINGOLIMOD HYDROCHLORIDE
CAS Number: 162359-56-0
Current Sponsor code: FTY720D
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: .5-

Primary Outcome(s)
Main Objective: To assess the long-term safety, tolerability, and efficacy (as measured by clinical and MRI parameters of disease activity) of fingolimod 0.5 mg/day in PPMS patients.
Primary end point(s): long-term safety, tolerability, and efficacy
Secondary Objective: none
Timepoint(s) of evaluation of this end point: Physical examination,Vital signs, Blood pressure, laboratory evaluations - All visits: Electrocardiogram, baseline, monthly through month 3, every 6 months afterwards); Dermatological and Ophthalmic examinations and Pulmonary Function Tests, yearly; EDSS, 9HPT and 25TWT every 6 months; MRI parameters, yearly.
Secondary Outcome(s)
Secondary end point(s): none
Timepoint(s) of evaluation of this end point: N.A.
Secondary ID(s)
2012-000835-18-SE
CFTY720D2306E1
Source(s) of Monetary Support
Novartis
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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