Tolerability and Safety and Health Outcomes in Relapsing Multiple Sclerosis (MS) Patients

NCT ID: NCT01127750

Last Updated: 2017-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2417 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-10-31

Brief Summary

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This study will assess tolerability and safety and health outcomes in relapsing MS patients taking FTY720.

Detailed Description

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Conditions

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Relapsing Multiple Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FTY720

Group Type EXPERIMENTAL

FTY720

Intervention Type DRUG

Interventions

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FTY720

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18-65 years of age, must have relapsing MS

Exclusion Criteria

* Patients with a type of MS that is not relapsing
* Patients with history of chronic immune disease
* Patients with a history of certain cancers
* Diabetic patients with certain eye disorders
* Patients who are on certain immunosuppressive medications or heart medications
* Patients with certain heart conditions
* Patients with certain lung conditions
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Box Hill, , Australia

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Heidelberg, , Australia

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Kogarah, , Australia

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Liverpool, , Australia

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Woodville South, , Australia

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Linz, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Bruges, , Belgium

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Brussels, , Belgium

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Brussels, , Belgium

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Charleroi, , Belgium

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Leuven, , Belgium

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Melsbroek, , Belgium

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Overpelt, , Belgium

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Sijsele, , Belgium

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Tinlot, , Belgium

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Wilrijk, , Belgium

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Montreal, , Canada

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Québec, , Canada

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Victoria, , Canada

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Prague, , Czechia

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Teplice, , Czechia

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Aarhus, , Denmark

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Copenhagen, , Denmark

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Helsinki, , Finland

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Turku, , Finland

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Aachen, , Germany

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Aachen, , Germany

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Aalen, , Germany

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Abensberg, , Germany

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Achim, , Germany

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Alzenau in Unterfranken, , Germany

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Aschaffenburg, , Germany

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Attenberg, , Germany

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Augsburg, , Germany

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Bad Honnef, , Germany

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Bad Krozingen, , Germany

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Bad Mergentheim, , Germany

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Bad Neustadt / Saale, , Germany

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Bayreuth, , Germany

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Jena, , Germany

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Karlsruhe, , Germany

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Nuremberg, , Germany

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Oldenburg, , Germany

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Alexandroupoli, , Greece

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Budapest, , Hungary

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Pécs, , Hungary

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Szeged, , Hungary

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Cork, , Ireland

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Dublin, , Ireland

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Acquaviva delle Fonti, , Italy

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Asti, , Italy

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Pozzilli, , Italy

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Amsterdam, , Netherlands

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Amsterdam, , Netherlands

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Blaricum, , Netherlands

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Breda, , Netherlands

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Enschede, , Netherlands

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Gouda, , Netherlands

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Tilburg, , Netherlands

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Lillehammer, , Norway

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Molde, , Norway

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Stavanger, , Norway

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Bydgoszcz, , Poland

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Katowice, , Poland

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Lodz, , Poland

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Amadora, , Portugal

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Coimbra, , Portugal

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Porto, , Portugal

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Kazan', , Russia

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Moscow, , Russia

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Nizhny Novgorod, , Russia

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Banská Bystrica, , Slovakia

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Trnava, , Slovakia

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Barcelona, , Spain

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Barcelona, , Spain

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Donostia / San Sebastian, , Spain

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El Palmar, , Spain

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Madrid, , Spain

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Santa Cruz de Tenerife, , Spain

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Santiago de Compostela, , Spain

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Valencia, , Spain

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Gothenburg, , Sweden

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Linköping, , Sweden

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Umeå, , Sweden

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Aarau, , Switzerland

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Carouge, , Switzerland

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Geneva, , Switzerland

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Lausanne, , Switzerland

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Lugano, , Switzerland

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Sankt Gallen, , Switzerland

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Zurich, , Switzerland

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Antalya, , Turkey (Türkiye)

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Gaziantep, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Samsun, , Turkey (Türkiye)

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Trabzon, , Turkey (Türkiye)

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Birmingham, , United Kingdom

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Dundee, , United Kingdom

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Great Yarmouth, , United Kingdom

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Headington, , United Kingdom

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London, , United Kingdom

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Middlesbrough, , United Kingdom

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Newcastle upon Tyne, , United Kingdom

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Northampton, , United Kingdom

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Norwick, , United Kingdom

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Poole, , United Kingdom

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Salford, , United Kingdom

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Sheffield, , United Kingdom

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Stoke-on-Trent, , United Kingdom

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Swindon, , United Kingdom

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Truro, , United Kingdom

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Countries

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Australia Austria Belgium Canada Czechia Denmark Finland Germany Greece Hungary Ireland Italy Netherlands Norway Poland Portugal Russia Slovakia Spain Sweden Switzerland Turkey (Türkiye) United Kingdom

References

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Gold R, Comi G, Palace J, Siever A, Gottschalk R, Bijarnia M, von Rosenstiel P, Tomic D, Kappos L; FIRST Study Investigators. Assessment of cardiac safety during fingolimod treatment initiation in a real-world relapsing multiple sclerosis population: a phase 3b, open-label study. J Neurol. 2014 Feb;261(2):267-76. doi: 10.1007/s00415-013-7115-8. Epub 2013 Nov 13.

Reference Type RESULT
PMID: 24221641 (View on PubMed)

Other Identifiers

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2010-019029-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CFTY720D2316

Identifier Type: -

Identifier Source: org_study_id

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