Clinical trial NCT00537082: Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis (MS)
Official title: A 6-month, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Comparing Efficacy and Safety of FTY720 0.5 mg and 1.25 mg Administered Orally Once Daily in Patients With Relapsing Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Sclerosis
Keywords: FTY720,
MS
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Mitsubishi Tanabe Pharma Corporation
First posted: 2007-09-28
Enrollment: 171
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: To provide efficacy and safety data of two doses (0.5 mg and 1.25 mg) of FTY720 in Japanese patients with relapsing multiple sclerosis (MS)


Eligibility criteria: Inclusion Criteria:

* Male and female patients aged 18-60
* Patients with a diagnosis of multiple sclerosis

Exclusion Criteria:

* Patients with a history or presence of chronic disease of the immune system other than MS
* Patients with a history or presence of malignancy, pulmonary or heart disease, etc.
* Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Number of Patients Free of Gadolinium-enhanced T1-Weighted Magnetic Resonance Imaging (MRI) Lesions at Both Month 3 and Month 6
timeFrame: Month 3 and Month 6
Secondary outcomes:
measure: Number of Patients Free of MS Relapse up to Month 6 (Confirmed Relapse Only)
timeFrame: up to Month 6
measure: Number of Patients Free of New or Newly Enlarged T2 Lesions
timeFrame: up to Month 3 and up to Month 6
measure: Annualized Relapse Rate (ARR) at 6 Months
timeFrame: 6 Months
Other outcomes:
Locations:
city: Sapporo-shi
country: Japan
facility: Novartis Investigative site
state: Hokkaido
city: Chiba
country: Japan
facility: Novartis Investigative Site
city: Ehime
country: Japan
facility: Novartis Investigative Site
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Gunma
country: Japan
facility: Novartis Investigative Site
city: Hyogo
country: Japan
facility: Novartis Investigative Site
city: Ibaraki
country: Japan
facility: Novartis Investigative Site
city: Iwate
country: Japan
facility: Novartis
city: Kanagawa
country: Japan
facility: Novartis Investigative Site
city: Kyoto
country: Japan
facility: Novartis Investigative Site
city: Kyoto
country: Japan
facility: Novartis Investigative Site
city: Niigata
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Tochigi
country: Japan
facility: Novartis Investigative Site
city: Tokyo
country: Japan
facility: Novartis Investigative Site
city: Tokyo
country: Japan
facility: Novartis Investigative Site
city: Wakayama
country: Japan
facility: Novartis Investigative Site
Study officials:
affiliation: +81 3 3797 8748
name: Novartis Pharmaceuticals, Japan
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saida T, Itoyama Y, Kikuchi S, Hao Q, Kurosawa T, Ueda K, Auberson LZ, Tsumiyama I, Nagato K, Kira JI. Long-term efficacy and safety of fingolimod in Japanese patients with relapsing multiple sclerosis: 3-year results of the phase 2 extension study. BMC Neurol. 2017 Jan 28;17(1):17. doi: 10.1186/s12883-017-0794-5.
citation: Saida T, Kikuchi S, Itoyama Y, Hao Q, Kurosawa T, Nagato K, Tang D, Zhang-Auberson L, Kira J. A randomized, controlled trial of fingolimod (FTY720) in Japanese patients with multiple sclerosis. Mult Scler. 2012 Sep;18(9):1269-77. doi: 10.1177/1352458511435984. Epub 2012 Feb 21.