Long Term Study of Fingolimod in MS Patients From the FTY Clinical Program

NCT ID: NCT01281657

Last Updated: 2012-09-06

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

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-07-31

Brief Summary

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The purpose of this observational study is to collect long-term data on safety and effectiveness of fingolimod, particularly including clinical disease and patient outcome related parameters such as relapse and disability, in patients who have participated in prior trials within the fingolimod clinical development program. Furthermore, this study explores the incidence of selected safety related outcomes of fingolimod treatment during follow-up visits within the context of routine medical practice.

Detailed Description

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Conditions

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Multiple Sclerosis

Keywords

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Fingolimod FTY720 Relapsing forms of multiple sclerosis Multiple sclerosis MS Safety Efficacy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Prescribed fingolimod 0.5 mg/day

fingolimod

Intervention Type DRUG

Interventions

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fingolimod

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who are prescribed fingolimod as part of their routine medical care
* Patients who have participated in a prior fingolimod clinical trials

Exclusion Criteria

* Restrictions regarding the use of fingolimod while pregnant or nursing in accordance with the local prescribing label
* Any patient who has prematurely discontinued from the previous fingolimod trial
Minimum Eligible Age

18 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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North Central Neurology Associates, PC

Cullman, Alabama, United States

Site Status

The Research & Education Inst. of Alta Bates Summit Med. Grp

Berkeley, California, United States

Site Status

Neuro-Therapeutics, Inc.

Pasadena, California, United States

Site Status

University of California San Francisco

San Francisco, California, United States

Site Status

Yale Multiple Sclerosis Center

New Haven, Connecticut, United States

Site Status

Georgetown University/Lombardi Cancer Center

Washington D.C., District of Columbia, United States

Site Status

Sunrise Clinical Research, Inc.

Hollywood, Florida, United States

Site Status

University of Florida

Jacksonville, Florida, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status

Neurological Associates

Pompano Beach, Florida, United States

Site Status

Neurology Clinical Research, Inc.

Sunrise, Florida, United States

Site Status

AMO Corporation

Tallahassee, Florida, United States

Site Status

MS Center of Vero Beach

Vero Beach, Florida, United States

Site Status

South Suburban Neurology

Flossmoor, Illinois, United States

Site Status

Neurologic Associates, LTD

Palos Heights, Illinois, United States

Site Status

Mercy Ruan Neurology Clinic Res Ct.

Des Moines, Iowa, United States

Site Status

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Mid America Neuroscience Institute

Lenexa, Kansas, United States

Site Status

University of Maryland

Baltimore, Maryland, United States

Site Status

Johns Hopkins MS Center

Baltimore, Maryland, United States

Site Status

Caritas St. Elizabeth's Hospital

Boston, Massachusetts, United States

Site Status

Springfield Neurology Associates, LLC

Springfield, Massachusetts, United States

Site Status

Spectrum Health Medical Group, Neurology

Grand Rapids, Michigan, United States

Site Status

Saint Luke's Hospital

Kansas City, Missouri, United States

Site Status

The MS Center for Innovation in Care

St Louis, Missouri, United States

Site Status

University of New Mexico Health Science Center

Albuquerque, New Mexico, United States

Site Status

Mount Sinai School of Medicine

New York, New York, United States

Site Status

Island Neurological Associates

Plainview, New York, United States

Site Status

SUNY - Stony Brook University

Stony Brook, New York, United States

Site Status

University of Toledo Health Science Campus

Toledo, Ohio, United States

Site Status

MS Center of Oklahoma

Oklahoma City, Oklahoma, United States

Site Status

Neurological Associates of Tulsa, Inc

Tulsa, Oklahoma, United States

Site Status

University of Pennsylvania Health System

Philadelphia, Pennsylvania, United States

Site Status

Thomas Jerfferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Vanderbilt University

Nashville, Tennessee, United States

Site Status

University of Texas Medical School

Houston, Texas, United States

Site Status

Integra Clinical Research

San Antonio, Texas, United States

Site Status

University of Virginia Health System

Charlottesville, Virginia, United States

Site Status

Swedish Neuroscience Institute

Seattle, Washington, United States

Site Status

Dean Foundation

Madison, Wisconsin, United States

Site Status

University of Wisconsin Madison

Madison, Wisconsin, United States

Site Status

St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Site Status

Novartis Investigative Site

Burnaby, British Columbia, Canada

Site Status

Novartis Investigative Site

Vancouver, British Columbia, Canada

Site Status

Novartis Investigative Site

Victoria, British Columbia, Canada

Site Status

Novartis Investigative Site

Halifax, Nova Scotia, Canada

Site Status

Novartis Investigative Site

Kingston, Ontario, Canada

Site Status

Novartis Investigative Site

London, Ontario, Canada

Site Status

Novartis Investigative Site

Nepean, Ontario, Canada

Site Status

Novartis Investigative Site

Ottawa, Ontario, Canada

Site Status

Novartis Investigative Site

Toronto, Ontario, Canada

Site Status

Novartis Investigative Site

Greenfield Park, Quebec, Canada

Site Status

Novartis Investigative Site

Montreal, Quebec, Canada

Site Status

Novartis Investigative Site

Montreal, Quebec, Canada

Site Status

Novartis Investigative Site

Montreal, Quebec, Canada

Site Status

Novartis Investigative Site

Québec, Quebec, Canada

Site Status

Novartis Investigative Site

Sherbrooke, Quebec, Canada

Site Status

Novartis Investigative Site

Regina, Saskatchewan, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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CFTY720D2399E1

Identifier Type: -

Identifier Source: org_study_id