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. - N/A

• Conditions: Relapsing-remitting multiple sclerosis.; MedDRA version: 9.1Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosis

• Registration Number: EUCTR2008-002096-27-LT
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1080

Inclusion Criteria

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

Exclusion Criteria

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. have received total lymphoid irradiation or bone marrow transplantation
8. have been treated with: (*)
9. any medically unstable condition, as assessed by the primary treating physician
10. any of the following cardiovascular conditions: (*)
11. any of the following pulmonary conditions: (*)
12. any of the following hepatic conditions: (*)
13. any of the following abnormal laboratory values: (*)
14. any of the following neurologic/psychiatric disorders: (*)
15. unable to undergo MRI scans, including claustrophobia or history of hypersensitivity to gadolinium-DTPA
16. participation in any clinical research study evaluating another investigational drug or therapy within 6 months prior to randomization
17. history of fingolimod therapy

(*) 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
Main Objective: The primary objective is to compare fingolimod 1.25 mg and 0.5 mg with placebo and to demonstrate that at least 1.25 mg fingolimod is superior to placebo in terms of annualized relapse rate for patients with RRMS treated for up to 24 months.;Secondary Objective: To demonstrate the effect of FTY720 relative to placebo on disability progression as<br>measured by the time to confirmed disability progression in patients treated for up<br>to 24 months.;Primary end point(s): The primary endpoint will be the annualized relapse rate (ARR), which is defined as the number of relapses in a year.