A 24-month, double-blind, randomized, multicenter, placebo-controlled, 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 sclerosis.MedDRA version: 9.1Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosis
- Registration Number
- EUCTR2005-000365-19-HU
- Lead Sponsor
- ovartis Pharma 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 a diagnosis of Multiple Sclerosis (2005 revised 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.
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 by the investigator.
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,
• use simultaneously two forms of effective contraception (either partner) during the treatment and for 3 months after discontinuation of the study medication.
Females that are either post-menopausal for 12 months prior to randomization or surgically sterile (through hysterectomy or bilateral oophorectomy) are not required to use birth control.
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
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 (=126 mg/dl or =7 mmol/L if fasting; =200 mg/dl or =11.1 mmol/L if random), 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-* 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, refer to Appendix 5) 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 for history of successfully treated tuberculosis or 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 (chronic) therapies for asthma.
15. Patients with any of the following hepatic conditions:
- known history of alcohol abuse, chronic liver or biliary disease
- total bilirubin greater than the upper limit of the normal range, unless in context o
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