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

Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis (FREEDOMS II)

This study has been completed.

First Received on October 15, 2008. Last Updated on November 22, 2011 History of Changes

Sponsor:	Novartis Pharmaceuticals
Information provided by (Responsible Party):	Novartis ( Novartis Pharmaceuticals )
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: FTY720	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
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])

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:

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 ]

Enrollment:	632
Study Start Date:	September 2008
Study Completion Date:	August 2011
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 FTY720	Drug: FTY720 0.5 mg FTY720

Eligibility

Ages Eligible for Study:	20 Years to 57 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Show 103 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

Novartis

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT00774670 History of Changes
Other Study ID Numbers:	CFTY720D2309E1
Study First Received:	October 15, 2008
Last Updated:	November 22, 2011
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

Additional relevant MeSH terms:

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

Immune System Diseases
Pathologic Processes
Fingolimod
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012