A 24-month double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis with optional extension phase - N/A
- Conditions
- Relapsing-remitting multiple sclerosis.MedDRA version: 9.1Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosis
- Registration Number
- EUCTR2008-002096-27-AT
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1080
General:
1. male or female females of childbearing potential must:
• have a negative pregnancy tests at Baseline prior to entry into the Double-Blind
Treatment Phase
• use simultaneously two forms of effective contraception (either partner) during the
treatment and for 3 months after discontinuation of the study medication females who are either post-menopausal for 12 months prior to Randomization or surgically sterile (through hysterectomy or bilateral oophorectomy) (if documented), are not required to use birth control.
2. 18 through 55 years of age inclusive
3. sign written informed consent prior to participating in the study
Multiple sclerosis:
4. diagnosis of multiple sclerosis as defined by 2005 revised McDonald criteria
5. a relapsing-remitting course with at least 1 documented relapse during the previous year or 2 documented relapses during the previous 2 years; prior to randomization
6. an Expanded Disability Status Scale (EDSS) score of 0-5.5 inclusive
7. neurologically stable with no evidence of relapse or corticosteroid treatment within 30 days prior to randomization
8. 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.
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
Patients who meet any of the following exclusion criteria during the Pre-Randomization Phase will not be eligible for enrollment in the study:
1. a manifestation of MS other than RRMS
2. a history of chronic disease of the immune system other than MS or a known immunodeficiency syndrome
3. a history or presence of malignancy (except for successfully treated basal or squamous cell carcinoma of skin)
4. a known or ‘new’ diagnosis of diabetes mellitus (if screening blood glucose is suspicious for diabetes [=126 mg/dL or =7 mmol/L if fasting; =200 mg/dL or 11.1 mmol/L if random testing] a patient should be further evaluated for diabetes mellitus)
5. a diagnosis of macular edema during Pre-randomization Phase (patients with a history of macular edema will be allowed to enter the study provided that they do not have macular edema at the ophthalmic screening visit).
6. active systemic bacterial, viral or fungal infections, or diagnosis of AIDS, Hepatitis B, Hepatitis C infection defined as a positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests, respectively
7. negative for varicella-zoster virus IgG antibodies at Screening
8. have received any live or live attenuated vaccines (including for varicella-zoster virus or measles) within 2 months prior to randomization
9. have received total lymphoid irradiation or bone marrow transplantation
(*) Please see enclosed protocol section 5.1 for all details.
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