A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis - ND
- Conditions
- MS (MULTIPLE SCLEROSIS)MedDRA version: 9.1Level: LLTClassification code 10048393
- Registration Number
- EUCTR2010-020515-37-IT
- Lead Sponsor
- OVARTIS FARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 4125
1. Written informed consent must be obtained before any assessment is performed. 2. Patients who have completed designated ongoing or planned trials with fingolimod.
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) yes
F.1.3.1 Number of subjects for this age range
1. Premature permanent discontinuation of a previous fingolimod study due to: a. An adverse event or serious adverse event or laboratory abnormality,except pregnancy. b. Conditions leading to permanent study drug discontinuation such as macular edema, elevated liver enzymes five times ULN (upper limit of normal), malignancy of any organ system. The full description of these exclusion criteria and monitoring guidelines is outlined in Appendix 5: Guidance on Safety Monitoring.2. 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).3. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods, at least 1 of which must be a primary form.4. Chronic disease of the immune system other than MS which may require immunosuppressive treatment. 5. Diabetic patients with moderate or severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy and uncontrolled diabetic patients with HbA1c > 8%. 6. Active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or have positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests. 7. Previous treatment with cladribine, cyclophosphamide or mitoxantrone. 8. Treatment with immunoglobulins and/or monoclonal antibodies (including Natalizumab) in the past 3 months during the previous fingolimod study: 9. Any medically unstable condition that may interfere with the patient’s ability to cooperate and comply with the study procedures, as assessed by the treating physician. 10. Any of the following cardiovascular conditions that have developed during the previous fingolimod study: a. myocardial infarction within the past 6 months prior to entry in the extension study or with current unstable ischemic heart disease; b. cardiac failure (Class III, according to New York Heart Association Classification) or any severe cardiac disease as determined by the investigator; c. arrhythmia requiring current treatment with Class III antiarrhythmic drugs (e.g., amiodarone, bretylium, sotalol, ibulitide, azimilide, dofelitide) d. history or presence of a third degree AV block e. proven history of sick sinus syndrome or sino-atrial heart block; f. known history of angina pectoris due to coronary spasm or Raynaud’s phenomenon; 11. Any of the following pulmonary conditions during the previous fingolimod study: a. Severe respiratory disease or pulmonary fibrosis diagnosed(during the previous fingolimod study); b. Active tuberculosis; 12. Alcohol abuse, chronic liver disease during the previous fingolimod study.
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