Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00333138
• Date of registration: 01/06/2006
• Prospective Registration: No
• Primary sponsor: Novartis
• Public title: Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis
• Scientific title: Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Evaluating the Safety, Tolerability and Effect on MRI Lesion Parameters of FTY720 vs Placebo in Patients With Relapsing Multiple Sclerosis Including 18 Month Extension Phase
• Date of first enrolment: May 2003
• Target sample size: 281
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00333138
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Canada, Denmark, Finland, France, Germany, Italy, Poland, Portugal, Spain, Switzerland, United Kingdom

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

Core Study

Inclusion Criteria:

- Diagnosis of relapsing multiple Sclerosis (MS)

- Patients with at least two documented relapses in the previous 2 years or one
documented relapse in the last year

- Patients with an Expanded Disability Status Scale (EDSS) score of 0-6

Extension Study

- A positive Gd-enhanced MRI scan at screening (in case the first MRI scan obtained at
screening was negative, a second scan could have been obtained 1 month later)

- Neurologically stable with no evidence of relapse within 30 days prior to
randomization,or during the Screening and Baseline periods.

- Female patients either post-menopausal, surgically incapable of bearing children, or
practicing an acceptable method of birth control. Females of childbearing potential
with a negative pregnancy test at baseline prior to entry into the treatment period.

Exclusion Criteria:

Core Study

- Patients with other chronic disease of the immune system, malignancies, pulmonary or
heart disease, etc

- Pregnant or nursing women

Extension Study

- Patients who had permanently discontinued study drug prior to the Month 6 visit of the
core study

- Patients with diabetes mellitus (to reduce the risk of ME), and therefore ongoing
patients with diabetes mellitus or who developed diabetes mellitus were discontinued
from the study)

Other protocol-defined inclusion/exclusion criteria may apply



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: FTY720

Drug: Placebo

Primary Outcome(s)

Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core) [Time Frame: Month 6 (Core)]

Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 12 [Time Frame: Month 12 (extension)]

Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at End of Study [Time Frame: Last observation (Up to 80 months in average)]

Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 60 [Time Frame: Month 60 (extension)]

Secondary Outcome(s)

Mean Number of New T2-weighted Lesions [Time Frame: (Core) Month 6 and (Extension) 12, 60, last observation (up to 80 months in average)]

Mean Trough Blood Concentrations of FTY720 [Time Frame: Month 3 and 6]

Percentage of Patients Free of Gd-enhanced T1-weighted and New T2- Weighted Lesions by Visit [Time Frame: Month 6 and 12, 60, last observation (up to 80 months in average)]

Volume of T2-weighted Lesions [Time Frame: (Core) Month 6 and (Extension) 12, 60, last observation (up to 80 months in average)]

Change From Baseline in Volume of Total T2-weighted Lesions [Time Frame: Baseline to month 6, 12, 60 and Last observation (up to 80 months in average)]

Time to Event Analysis: Kaplan Meier Estimates of Percentage of Relapse-free Patients [Time Frame: Month 6,12,60 and Last observation (up to 80 months in average)]

Percentage of Participants Free of T1-weighted Lesions [Time Frame: Baseline, Months 6 (core), 12, 60 and Last Observation (up to 80 months in average)]

Secondary ID(s)

CFTY720D2201

CFTY720D2201E1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 30/10/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00333138