Relapsing-remitting multiple sclerosis (RRMS)
Conditions
Interventions
Product Code: FTY720
Pharmaceutical Form: Capsule*
CAS Number: 162359-56-0
Current Sponsor code: FTY720
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5, 1.25-
P
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged 18-55 with a diagnosis of Multiple Sclerosis (2005 revised McDonald criteria). 2. Patients with a relapsing-remitting course with at least 1 documented relapse during the last year or 2 documented relapses in the past 2 years, preceding their enrollment to the study. 3. Patients with Expanded Disability Status Scale (EDSS) score of 0-5.5 4. Patients who explicitly decline initiation or continuation of treatment with available disease modifying drugs for whatever reason after having been informed about their respective benefits and possible adverse events. 5. Neurologically stable patients with no evidence of relapse for at least 30 days prior to randomization. 6. Females of childbearing potential must have a negative pregnancy test at Baseline prior to entry into the Treatment period, or be either post-menopausal for 12 months prior to Screening or surgically sterile, or use adequate contraception during the treatment and 3 months after discontinuation of the study medication. 7. All patients must give written consent for participation in the study prior to the Screening. 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with a manifestation of MS other than RRMS. 2. Patients with a history of chronic disease of the immune system other than MS or with a known immunodeficiency syndrome. 3. Patients with a history or presence of malignancy (except of successfully treated basal or squamous cell carcinoma of skin). 4. Patients with a known diagnosis of diabetes mellitus or a screening blood glucose suspicious for diabetes, patients with macular edema at Screening visit. 5. Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or to have positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests. 6. Patients who have received total lymphoid irradiation or bone marrow transplantation. 7. Patients who have been treated with corticosteroids or adrenocorticotropic hormones (ACTH) in the past 30 days prior to randomization. 8. Patients who have been previously treated with cladribine, cyclophosphamide or mitoxantrone. 9. Patients who have been treated with immunosuppressive medications such as azathioprine or methotrexate in the past 6 months prior to randomization. 10. Patients who have been treated with IFN-beta or glatiramer acetate in the past 3 months prior to randomization. 11. Patients who have been treated with immunoglobulins and/or monoclonal antibodies (including natalizumab) in the past 6 months prior to randomization. 12. Patients with any medically unstable condition, as assessed by the primary treating physician at each site. 13. Patients with any of the following cardiovascular conditions: • history of cardiac arrest; • myocardial infarction within the past 6 months prior to enrollment or with current unstable ischemic heart disease; • cardiac failure at time of Screening (Class III, according to New York Heart Association Classification) or any severe cardiac disease as determined by the investigator; • past or current history of recurrent symptomatic bradycardia; • history or presence of a second degree AV block or a third degree AV block or an increased QTc interval >440 ms on screening ECG; • arrhythmia requiring current treatment with Class III antiarrhythmic drugs (e.g., amiodarone, bretylium, sotalol, ibulitide, azimilide, dofelitide). • resting pulse rate <55 bpm prior to randomization; • proven history of sick sinus syndrome or sino-atrial heart block; • history of a positive tilt test from workup for vasovagal syncope; • known history of angina pectoris due to coronary spasm or history of Raynaud's phenomenon; • hypertension, not controlled by prescribed medications, 14. Patients with any of the following pulmonary conditions: • severe respiratory disease or pulmonary fibrosis; • tuberculosis, except of history of successfully treated tuberculosis of history of prophylactic treatment after positive PPD skin reaction; • abnormal chest x-ray or High Resolution Computer Tomography (HRCT) [at selected sites] suggestive of active pulmonary disease; • abnormal Pulmonary Function Tests: FEV1, FVC values lower than 70% of predicted, DLCO values lower than 60% of predicted; • patients receiving daily therapies for asthma 15. Patients with any of the following hepatic conditions: • known history of alcohol abuse, chronic liver or biliary disease, with the exception of Gilbert’s syndrome; • AST (SGOT), ALT (SGPT) greater than 2 times the upper limit of the normal range; • alkaline phosphatase (AP) greater tha
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare FTY720 1.25 mg and 0.5 mg with placebo and to demonstrate that at least the 1.25 mg FTY720 dose is superior to placebo as assessed by the annualised relapse rate in patients with RRMS treated for up to 24 months.;Secondary Objective: Key secondary objective: •To evaluate the effect of FTY720 1.25 mg and 0.5 mg relative to placebo on disability progression as measured by the time to 3-month confirmed disability progression as measured by EDSS in patients treated for up to 24 months. Other secondary objectives: •To evaluate the safety and tolerability of FTY720 compared to placebo in patients with RRMS treated up to 24 months. •To evaluate the effect of FTY720 1.25 mg and 0.5 mg compared to placebo in patients treated for up to 24 months with respect to relapse related parameters: - time to the first relapse - proportion of relapse-free patients Please refer to Section 3 of the enclosed protocol for the entire description of the objectives. ;Primary end point(s): The primary endpoint will be annualized relapse rate ( ARR) at 24 months, which is defined as the number of relapses per year. | — |
Countries
Czech Republic, Estonia, Finland, Germany, Greece, Hungary, Ireland, Lithuania, Sweden, United Kingdom
Outcome results
None listed