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

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2008-002096-27-GB
• Date of registration: 14/10/2008
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 28/11/2008
• Target sample size: 1080
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-002096-27
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Austria, Lithuania, Poland, United Kingdom

Key inclusion & exclusion criteria

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

(*) Please see enclosed protocol section 5.1 for all details.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Relapsing-remitting multiple sclerosis.
MedDRA version: 9.1 Level: LLT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis

Intervention(s)

Product Name: Fingolimod
Product Code: FTY720D
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Fingolimod
CAS Number: 162359-56-0
Current Sponsor code: FTY720D
Other descriptive name: FTY720
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: The primary objective is to demonstrate that 0.5 mg/day fingolimod is superior to placebo as assessed by the annualized relapse rate (ARR) in patients with RRMS treated for up to 24 months.

Primary end point(s): The primary endpoint will be the annualized relapse rate (ARR) at 24 months, which is defined as the number of relapses in a year.

Secondary Objective: 1. To evaluate the effect of fingolimod 0.5 mg/day relative to placebo on the percentage change from base;ine in brain atrophy in patients with RRMS treated for up to 24 months.
2. To evaluate the effect of fingolimod 0.5 mg/day relative to placebo on disability progression as measured by the time to 3-month confirmed disability progression as measured by EDSS in patients with RRMS treated for up to 24 months.

Secondary ID(s)

2008-002096-27-PL

CFTY720D2309