Long Term Efficacy and Safety of FTY720 in Patients With Relapsing-Remitting Multiple Sclerosis

This study is enrolling participants by invitation only.

First Received: April 17, 2008 Last Updated: April 18, 2008 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00662649

Purpose

This extension study is designed to evaluate the long-term safety, tolerability and efficacy of FTY720 in patients with multiple sclerosis.

Condition	Intervention	Phase
Multiple Sclerosis	Drug: Fingolimod (FTY720)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Extension of the 24-Month, Double-Blind, Randomized, Multicenter, Placebo-Controlled, Parallel-Group Study Comparing Efficacy and Safety of FTY720 1.25 mg and 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Relapsing-Remitting Multiple Sclerosis

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Fingolimod FTY 720

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

All safety analyses will be based mainly on the frequency of adverse events and on the incidence of clinically notable laboratory abnormalities.

Estimated Enrollment:	1250
Study Start Date:	February 2008
Estimated Study Completion Date:	August 2011

Arms	Assigned Interventions
1: Experimental FTY720 0.5mg/daily	Drug: Fingolimod (FTY720)
2: Experimental FTY720 1.25mg/day	Drug: Fingolimod (FTY720)

Eligibility

Ages Eligible for Study:	20 Years to 58 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients should complete the 24 month core study

Exclusion Criteria:

Patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc.
Pregnant or nursing women Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662649

Locations

Australia
Austin Health, Department of Neurology
Heidelberg, Australia

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis Pharmaceuticals

More Information

Additional Information:

Fingolimod clinical trials information website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CFTY720D2301E1
Study First Received:	April 17, 2008
Last Updated:	April 18, 2008
ClinicalTrials.gov Identifier:	NCT00662649 History of Changes
Health Authority:	Sweden: Regional Ethical Review Board

Keywords provided by Novartis:

Multiple sclerosis.
Relapse-remitting
Fingolimod

Study placed in the following topic categories:

Autoimmune Diseases
Multiple Sclerosis
Immunologic Factors
Demyelinating Diseases
Fingolimod

Demyelinating Autoimmune Diseases, CNS
Sclerosis
Immunosuppressive Agents
Multiple Sclerosis, Relapsing-Remitting
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Autoimmune Diseases
Demyelinating Diseases
Immune System Diseases
Immunologic Factors
Fingolimod
Physiological Effects of Drugs
Nervous System Diseases
Sclerosis

Multiple Sclerosis, Relapsing-Remitting
Immunosuppressive Agents
Pharmacologic Actions
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on September 10, 2009