Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis (MS)

NCT ID: NCT00537082

Last Updated: 2011-04-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Brief Summary

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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)

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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FTY720 0.5 mg

FTY720

Group Type EXPERIMENTAL

FTY720

Intervention Type DRUG

Administered orally once daily for 6 months

FTY720 1.25 mg

FTY720

Group Type EXPERIMENTAL

FTY720

Intervention Type DRUG

Administered orally once daily for 6 months

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally once daily for 6 months

Interventions

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FTY720

Administered orally once daily for 6 months

Intervention Type DRUG

Placebo

Administered orally once daily for 6 months

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mitsubishi Tanabe Pharma Corporation

INDUSTRY

Sponsor Role collaborator

Novartis

INDUSTRY

Sponsor Role lead

Principal Investigators

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Novartis Pharmaceuticals, Japan

Role: PRINCIPAL_INVESTIGATOR

+81 3 3797 8748

Locations

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Novartis Investigative site

Sapporo, Hokkaido, Japan

Site Status

Novartis Investigative Site

Chiba, , Japan

Site Status

Novartis Investigative Site

Ehime, , Japan

Site Status

Novartis Investigative Site

Fukuoka, , Japan

Site Status

Novartis Investigative Site

Gunma, , Japan

Site Status

Novartis Investigative Site

Hyōgo, , Japan

Site Status

Novartis Investigative Site

Ibaraki, , Japan

Site Status

Novartis Investigative Site

Kanagawa, , Japan

Site Status

Novartis Investigative Site

Kyoto, , Japan

Site Status

Novartis Investigative Site

Kyoto, , Japan

Site Status

Novartis Investigative Site

Niigata, , Japan

Site Status

Novartis

Numakunai, , Japan

Site Status

Novartis Investigative Site

Osaka, , Japan

Site Status

Novartis Investigative Site

Osaka, , Japan

Site Status

Novartis Investigative Site

Tochigi, , Japan

Site Status

Novartis Investigative Site

Tokyo, , Japan

Site Status

Novartis Investigative Site

Tokyo, , Japan

Site Status

Novartis Investigative Site

Wakayama, , Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 22354739 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28129749 (View on PubMed)

Other Identifiers

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CFTY720D1201

Identifier Type: -

Identifier Source: org_study_id

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