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An Extension Study of the Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing Multiple Sclerosis

NCT ID: NCT00670449

Last Updated: 2013-09-04

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

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2012-04-30

Brief Summary

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This study was an extension study of NCT00537082. This study was designed to evaluate the efficacy and safety of long-term administration of 0.5 mg or 1.25 mg of fingolimod (FTY720) to relapsing multiple sclerosis.

Detailed Description

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A decision was made to switch all patients on fingolimod 1.25 mg/day to fingolimod 0.5 mg/day in an amendment to the study protocol. The study became open-label with all patients receiving fingolimod 0.5 mg/day on 22 Feb 2010.

The efficacy data for Months 0-6 in this study report is from the core study NCT00537082.

Conditions

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Multiple Sclerosis

Keywords

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FTY720 multiple sclerosis MS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Fingolimod 0.5 mg

Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.

Group Type EXPERIMENTAL

Fingolimod

Intervention Type DRUG

Fingolimod was supplied in capsules.

Fingolimod 1.25 mg

Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.

Group Type EXPERIMENTAL

Fingolimod

Intervention Type DRUG

Fingolimod was supplied in capsules.

Placebo-fingolimod

Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.

Group Type EXPERIMENTAL

Fingolimod

Intervention Type DRUG

Fingolimod was supplied in capsules.

Interventions

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Fingolimod

Fingolimod was supplied in capsules.

Intervention Type DRUG

Other Intervention Names

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Gilenya Imsera

Eligibility Criteria

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Inclusion Criteria

* Patients who completed 6 months of treatment with the study drug and the Month 6 visit in the core study NCT00537082.
* Females of childbearing potential who have a negative pregnancy test in the core study NCT00537082.

Exclusion Criteria

* Patients who permanently discontinued study drug treatment prior to the Month 6 visit in the core study NCT00537082.
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

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals, Japan

Role: PRINCIPAL_INVESTIGATOR

81-3-3797-8748

Locations

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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

Morioka, , Japan

Site Status

Novartis Investigative Site

Niigata, , Japan

Site Status

Novartis Investigative Site

Osaka, , Japan

Site Status

Novartis Investigative Site

Osaka, , Japan

Site Status

Novartis Investigative Site

Osaka, , Japan

Site Status

Novartis Investigative Site

Sapporo, , 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

Tokyo, , Japan

Site Status

Novartis Investigative Site

Wakayama, , Japan

Site Status

Countries

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Japan

References

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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)

Kira J, Itoyama Y, Kikuchi S, Hao Q, Kurosawa T, Nagato K, Tsumiyama I, von Rosenstiel P, Zhang-Auberson L, Saida T. Fingolimod (FTY720) therapy in Japanese patients with relapsing multiple sclerosis over 12 months: results of a phase 2 observational extension. BMC Neurol. 2014 Jan 29;14:21. doi: 10.1186/1471-2377-14-21.

Reference Type DERIVED
PMID: 24475777 (View on PubMed)

Other Identifiers

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CFTY720D1201E1

Identifier Type: -

Identifier Source: org_study_id