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

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: fingolimod

• Registration Number: NCT01281657
• Lead Sponsor: Novartis

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2011-01-19
• Study First Submitted QC: 2011-01-21
• Study First Posted: 2011-01-24
• Study Start: 2011-02
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-05
• Last Update Posted: 2012-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prescribed fingolimod 0.5 mg/day	fingolimod	-

Primary Outcome Measures

Name	Time	Method
Long-term safety data in patients with relapsing forms of multiple sclerosis who have participated in clinical trials with fingolimod and who are now taking prescribed fingolimod under the conditions of routine medical practice	Throughout the entirety of the study up to a maximum of 8 years

Secondary Outcome Measures

Name	Time	Method
Long-term effectiveness data, particularly including clinical disease and patient outcome related parameters such as relapse and disability	Throughout the entirety of the study up to a maximum of 8 years

Trial Locations

Locations (43)

North Central Neurology Associates, PC; 🇺🇸 Cullman, Alabama, United States

The Research & Education Inst. of Alta Bates Summit Med. Grp; 🇺🇸 Berkeley, California, United States

Neuro-Therapeutics, Inc.; 🇺🇸 Pasadena, California, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States

Yale Multiple Sclerosis Center; 🇺🇸 New Haven, Connecticut, United States

Georgetown University/Lombardi Cancer Center; 🇺🇸 Washington, District of Columbia, United States

Sunrise Clinical Research, Inc.; 🇺🇸 Hollywood, Florida, United States

University of Florida; 🇺🇸 Jacksonville, Florida, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Neurological Associates; 🇺🇸 Pompano Beach, Florida, United States

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