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A Single Arm, Open-label, Multicenter Study Evaluating the Long-term Safety and Tolerability of 0.5 mg Fingolimod (FTY720) Administered Orally Once Daily in Patients With Relapsing Forms of Multiple Sclerosis
The purpose of this study was to collect long-term safety and tolerability, long-term efficacy, and health outcome data in all patients currently ongoing in the fingolimod multiple sclerosis clinical development program. This study combined all currently ongoing Phase II and III fingolimod extension studies as well as ongoing and newly planned studies into one single long-term extension protocol that provided patients with continuous treatment until fingolimod was registered, commercially available, and reimbursed in the respective countries.
This study had two parts: * Part 1, collecting long-term safety, tolerability, efficacy and health outcomes data through approximately 30-Jun-2016 until all end of study (EOS) visits of Part 1 and last follow-up visit through Jan-2017 and * Part 2, collecting limited safety and tolerability data until approximately 30 Jun 2018, in a subset of patients who participated in Part 1, and other eligible patients from ongoing fingolimod trials.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Novartis Investigative Site
Cullman, Alabama, United States
Novartis Investigative Site
Oceanside, California, United States
Novartis Investigative Site
Sacramento, California, United States
Novartis Investigative Site
San Francisco, California, United States
Novartis Investigative Site
Washington D.C., District of Columbia, United States
Novartis Investigative Site
Jacksonville, Florida, United States
Novartis Investigative Site
Maitland, Florida, United States
Novartis Investigative Site
Miami, Florida, United States
Novartis Investigative Site
Sunrise, Florida, United States
Novartis Investigative Site
Tallahassee, Florida, United States
Start Date
September 13, 2010
Primary Completion Date
October 19, 2018
Completion Date
October 19, 2018
Last Updated
April 21, 2021
4,125
ACTUAL participants
Fingolimod
DRUG
Lead Sponsor
Novartis Pharmaceuticals
NCT06681623
NCT06251986
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04676555