Primary progressive multiple sclerosis. MedDRA version: 16.0 Level: PT Classification code 10063401 Term: Primary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion 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: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 700 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Active chronic disease (or stable but treated with immune therapy) of the immune system other than MS (e.g., rheumatoid arthritis, scleroderma, Sjögren'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. Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS, hepatitis A, hepatitis B, hepatitis C, hepatitis E infection or to have positive HIV antibody, hepatitis B surface antigen or hepatitis C antibody tests. 3. Uncontrolled diabetes mellitus (HbA1c>7%). 4. Not applicable – this exclusion criterion was deleted in Amendment 1. 5. Macular edema at baseline. 6. Treatment with Class Ia or III antiarrhythmic drugs (e.g., amiodarone, bretylium, sotalol, ibutilide, azimilide, dofetilide). 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 9. Any of the following hepatic conditions at Baseline: • severe hepatic injury (Child-Pugh class C) • history of alcohol abuse, chronic liver or biliary disease, acute or chronic pancreatitis, with the exception of Gilbert's syndrome • 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. 11. Participation in any clinical research study other than CFTY720D2306 evaluating another investigational drug or therapy within 6 months prior to extension baseline. 12. Pregnant or nursing (lactating) women where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL). 13. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS they are using highly effective contraception during dosing with study treatment. Highly effective contraception includes: • Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. • Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least 6 weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment. • Male partner
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;Secondary Objective: none;Primary end point(s): Long-term safety, tolerability, and efficacy. ;Timepoint(s) of evaluation of this end point: Physical examination: baseline, yearly Vital signs: every visit Laboratory evaluations: every visit Electrocardiogram (ECG): baseline, day 1 Dermatological examination: baseline, yearly Ophthalmic examination: baseline, month 3 EDSS, 9HPT, 25TWT: baseline, every 6 months MRI: baseline, yearly Pregnancy test: every visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): none;Timepoint(s) of evaluation of this end point: none | — |
Countries
Australia, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States
Contacts
Public ContactClinical Trial Information Desk
Novartis Pharma AG
Outcome results
None listed