Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-Remitting Multiple Sclerosis - Full Text View

Sponsored by:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00774670

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

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: FTY 720 Fingolimod

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment
Official Title:	Extension to CFTY720D2309 (24-Month Double-Blind, Randomized, Multicenter, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod [FTY720] Administered Orally Once Daily Versus Placebo in Patients With Relapsing-Remitting Multiple Sclerosis [RRMS])

Further study details as provided by Novartis:

Primary Outcome Measures:

To evaluate the long-term safety and tolerability of FTY720 in patients with RRMS using vital signs, PFTs, CXR or HRCT findings, bradycardia events, dermatologic and opthalmic exams & ECG data. [ Time Frame: completed when FTY720 becomes available on the market or development is terminated. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the long-term efficacy of FTY720 in patients with RRMS using annualized relapse rate, EDSS & MSFC scores, and number of MRI Gd-enhanced T1-weighted lesions. [ Time Frame: completed when FTY720 becomes available on the market or development is terminated. ] [ Designated as safety issue: No ]

Estimated Enrollment:	930
Study Start Date:	September 2008
Estimated Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

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

Eligibility

Criteria

Inclusion Criteria:

Patients with relapsing-remitting disease who completed the 24 month core study with or without 24 months on study drug.

Exclusion Criteria:

Other chronic diseases and conditions: of the immune system, malignancies, macular edema, diabetes, respiratory, cardiovascular.
Active systemic bacterial, viral or fungal infections.
Nursing and pregnant women.

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00774670

Locations

United States, Texas
Investigational Site - Private Practice
Lubbock, Texas, United States

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

Novartis

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CFTY720D2309E1
Study First Received:	October 15, 2008
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00774670
Health Authority:	United States: Food and Drug Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Lithuania: State Medicine Control Agency - Ministry of Health; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Romania: National Medicines Agency; Turkey: Ministry of Health

Keywords provided by Novartis:

Multiple sclerosis, relapsing-remitting, fingolimod

Study placed in the following topic categories:

Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Fingolimod
Demyelinating Autoimmune Diseases, CNS

Demyelinating diseases
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Pathologic Processes
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs

Nervous System Diseases
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009