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Completed Phase 3 Interventional Results available

Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis

ClinicalTrials.gov ID: NCT01201356

Public ClinicalTrials.gov record NCT01201356. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 9:54 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01201356
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
4,125 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 13, 2010 (Actual)
Primary completion
Oct 19, 2018 (Actual)
Completion
Oct 19, 2018 (Actual)
Last update posted
Apr 21, 2021

2010 – 2018

United States locations

U.S. sites
34
U.S. states
21
U.S. cities
33
Facility City State ZIP Site status
Novartis Investigative Site Cullman Alabama 35058 —
Novartis Investigative Site Oceanside California 92056 —
Novartis Investigative Site Sacramento California 95817 —
Novartis Investigative Site San Francisco California 94143 —
Novartis Investigative Site Washington D.C. District of Columbia 20007 —
Novartis Investigative Site Jacksonville Florida 32209 —
Novartis Investigative Site Maitland Florida 32751 —
Novartis Investigative Site Miami Florida 33136 —
Novartis Investigative Site Sunrise Florida 33351 —
Novartis Investigative Site Tallahassee Florida 32308 —
Novartis Investigative Site Tampa Florida 33609 —
Novartis Investigative Site Vero Beach Florida 32960 —
Novartis Investigative Site Atlanta Georgia 30327 —
Novartis Investigative Site Kansas City Kansas 66160 —
Novartis Investigative Site Lenexa Kansas 66212 —
Novartis Investigative Site Baltimore Maryland 21201 —
Novartis Investigative Site Baltimore Maryland 21287 —
Novartis Investigative Site Kansas City Missouri 64111 —
Novartis Investigative Site Lebanon New Hampshire 03756 —
Novartis Investigative Site Albuquerque New Mexico 87131-0001 —
Novartis Investigative Site New York New York 10021 —
Novartis Investigative Site Durham North Carolina 27710 —
Novartis Investigative Site Raleigh North Carolina 27607 —
Novartis Investigative Site Toledo Ohio 43614 —
Novartis Investigative Site Oklahoma City Oklahoma 73104 —
Novartis Investigative Site Tulsa Oklahoma 74136 —
Novartis Investigative Site Tualatin Oregon 97062 —
Novartis Investigative Site Pittsburgh Pennsylvania 15213 —
Novartis Investigative Site Bristol Tennessee 37620 —
Novartis Investigative Site Nashville Tennessee 37212 —
Novartis Investigative Site San Antonio Texas 78229 —
Novartis Investigative Site Burlington Vermont 05401 —
Novartis Investigative Site Charlottesville Virginia 22904 —
Novartis Investigative Site Seattle Washington 98122 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 424 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01201356, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 21, 2021 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01201356 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →