Clinical trial NCT00333138: Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Sclerosis
Keywords: FTY720
MS
Multiple Sclerosis
RRMS
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-06-02
Enrollment: 281
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluated the safety, tolerability and effect on MRI lesion parameters of FTY720 in patients with relapsing multiple sclerosis.


Eligibility 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

Primary outcomes:
measure: Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core)
timeFrame: Month 6 (Core)
measure: Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 12
timeFrame: Month 12 (extension)
measure: Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 60
timeFrame: Month 60 (extension)
measure: Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at End of Study
timeFrame: Last observation (Up to 80 months in average)
Secondary outcomes:
measure: Percentage of Participants Free of T1-weighted Lesions
timeFrame: Baseline, Months 6 (core), 12, 60 and Last Observation (up to 80 months in average)
measure: Percentage of Patients Free of Gd-enhanced T1-weighted and New T2- Weighted Lesions by Visit
timeFrame: Month 6 and 12, 60, last observation (up to 80 months in average)
measure: Mean Number of New T2-weighted Lesions
timeFrame: (Core) Month 6 and (Extension) 12, 60, last observation (up to 80 months in average)
measure: Volume of T2-weighted Lesions
timeFrame: (Core) Month 6 and (Extension) 12, 60, last observation (up to 80 months in average)
measure: Change From Baseline in Volume of Total T2-weighted Lesions
timeFrame: Baseline to month 6, 12, 60 and Last observation (up to 80 months in average)
measure: Time to Event Analysis: Kaplan Meier Estimates of Percentage of Relapse-free Patients
timeFrame: Month 6,12,60 and Last observation (up to 80 months in average)
measure: Mean Trough Blood Concentrations of FTY720
timeFrame: Month 3 and 6
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Novartis Investigational site
city: Ottawa
country: Canada
facility: Novartis Investigational site
city: Toronto
country: Canada
facility: Novartis Investigational site
city: Vancouver
country: Canada
facility: Novartis Investigational site
city: Copenhagen
country: Denmark
facility: Novartis Investigational site
city: Helsinki
country: Finland
facility: Novartis Investigational site
city: Turku
country: Finland
facility: Novartis Investigational site
city: Lille
country: France
facility: Novartis Investigational site
city: Marseille
country: France
facility: Novartis Investigational site
city: Schwendi
country: Germany
facility: Novartis Investigational site
city: Wurzburg
country: Germany
facility: Novartis Investigational site
city: Gallarate
country: Italy
facility: Novartis Investigational site
city: Genova
country: Italy
facility: Novartis Investigational site
city: Milano
country: Italy
facility: Novartis Investigational site
city: Roma
country: Italy
facility: Novartis Investigational site
city: Warszawa
country: Poland
facility: Novartis Investigational site
city: Coimbra
country: Portugal
facility: Novartis Investigational site
city: Lisboa
country: Portugal
facility: Novartis Investigational site
city: Barcelona
country: Spain
facility: Novartis Investigational site
city: Madrid
country: Spain
facility: Novartis Investigational site
city: Malaga
country: Spain
facility: Novartis Investigational site
city: Sevilla
country: Spain
facility: Novartis Investigational site
city: Valencia
country: Spain
facility: Novartis Investigational site
city: Basel
country: Switzerland
facility: Novartis Investigational site
city: Zurich
country: Switzerland
facility: Novartis Investigational site
city: Newcastle upon Tyne
country: United Kingdom
facility: Novartis Investigational site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References:
citation: Zarbin MA, Jampol LM, Jager RD, Reder AT, Francis G, Collins W, Tang D, Zhang X. Ophthalmic evaluations in clinical studies of fingolimod (FTY720) in multiple sclerosis. Ophthalmology. 2013 Jul;120(7):1432-9. doi: 10.1016/j.ophtha.2012.12.040. Epub 2013 Mar 24.
citation: Kappos L, Antel J, Comi G, Montalban X, O'Connor P, Polman CH, Haas T, Korn AA, Karlsson G, Radue EW; FTY720 D2201 Study Group. Oral fingolimod (FTY720) for relapsing multiple sclerosis. N Engl J Med. 2006 Sep 14;355(11):1124-40. doi: 10.1056/NEJMoa052643.