A 24A 24-month, double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis
- Conditions
- Relapsing-remitting multiple sclerosisMedDRA version: 9.1Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosis
- Registration Number
- EUCTR2005-000365-19-LT
- Lead Sponsor
- ovartisPharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1250
1. Male and female patients aged 18-55 with clinically definite diagnosis of Multiple Sclerosis (McDonald criteria) see Appendix 3.
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 (signing of the study consent form).
3. Patients with Expanded Disability Status Scale (EDSS) score of 0-5.5 at Screening.
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 the Screening visit.
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 at 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
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 history of uncontrolled diabetes mellitus, macular edema or other retinal vascular diseases known to be associated with macular edema, e.g. retinal vein occlusion.
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 the Screening visit.
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 the Screening visit.
10. Patients who have been treated with IFN-ß or glatiramer acetate in the past 3 months prior to the Screening visit.
11. Patients who have been treated with immunoglobulins and/or monoclonal antibodies (including natalizumab) in the past 6 months prior to the Screening visit.
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 (e.g. syncope); 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 at Screening or at Baseline; proven history of sino-atrial heart block;
history of vagal syncope with a positive tilt test; hypertension, not controlled by prescribed medications.
14. Patients with any of the following pulmonary conditions: severe respiratory disease or pulmonary fibrosis; tuberculosis, except for history of successfully treated tuberculosis or history of prophylactic treatment after positive PPD; abnormal chest x-ray suggestive of active pulmonary disease; abnormal Pulmonary Function Tests values lower than 70% of predicted at Screening.
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 at
Screening; alkaline phosphatase (AP) greater than 1.5 times the upper limit of the normal range at Screening; gamma-glytamyl-transferase (GGT) greater than 3 times the upper limit of the normal range at Screening; total or conjugated bilirubin greater than the upper normal limits at Screening.
16. Patients with any of the abnormal lab
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method