Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis (MS)
A 6-month, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Comparing Efficacy and Safety of FTY720 0.5 mg and 1.25 mg Administered Orally Once Daily in Patients With Relapsing Multiple Sclerosis
1 other identifier
interventional
171
1 country
18
Brief Summary
To provide efficacy and safety data of two doses (0.5 mg and 1.25 mg) of FTY720 in Japanese patients with relapsing multiple sclerosis (MS)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 multiple-sclerosis
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 26, 2007
CompletedFirst Posted
Study publicly available on registry
September 28, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedResults Posted
Study results publicly available
March 23, 2011
CompletedApril 21, 2011
April 1, 2011
2.4 years
September 26, 2007
February 21, 2011
April 19, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Patients Free of Gadolinium-enhanced T1-Weighted Magnetic Resonance Imaging (MRI) Lesions at Both Month 3 and Month 6
Brain Magnetic Resonance Imaging (MRI) was performed at Month 3 and Month 6. Gadolinium-enhancing lesions (active lesions) represent acute inflammatory activity only and dissipate within 2-8 weeks of appearance. MRI scans were analyzed by blinded readers at the central MRI Evaluation Center to ensure consistency. Any Gd-enhanced T1 weighted MRI data obtained less than 14 days after the steroid used to treat MS relapses is invalid and excluded.
Month 3 and Month 6
Secondary Outcomes (3)
Number of Patients Free of MS Relapse up to Month 6 (Confirmed Relapse Only)
up to Month 6
Number of Patients Free of New or Newly Enlarged T2 Lesions
up to Month 3 and up to Month 6
Annualized Relapse Rate (ARR) at 6 Months
6 Months
Study Arms (3)
FTY720 0.5 mg
EXPERIMENTALFTY720
FTY720 1.25 mg
EXPERIMENTALFTY720
Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Male and female patients aged 18-60
- Patients with a diagnosis of multiple sclerosis
You may not qualify if:
- Patients with a history or presence of chronic disease of the immune system other than MS
- Patients with a history or presence of malignancy, pulmonary or heart disease, etc.
- Pregnant or nursing (lactating) women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
- Tanabe Pharma Corporationcollaborator
Study Sites (18)
Novartis Investigative site
Sapporo, Hokkaido, Japan
Novartis Investigative Site
Chiba, 276-8524, Japan
Novartis Investigative Site
Ehime, 791-0295, Japan
Novartis Investigative Site
Fukuoka, 807-8555, Japan
Novartis Investigative Site
Gunma, 371-8511, Japan
Novartis Investigative Site
Hyōgo, 650-0017, Japan
Novartis Investigative Site
Ibaraki, 305-8576, Japan
Novartis Investigative Site
Kanagawa, 259-1193, Japan
Novartis Investigative Site
Kyoto, 604-8453, Japan
Novartis Investigative Site
Kyoto, 616-8255, Japan
Novartis Investigative Site
Niigata, 951-8520, Japan
Novartis
Numakunai, 020-8505, Japan
Novartis Investigative Site
Osaka, 556-0016, Japan
Novartis Investigative Site
Osaka, 589-8511, Japan
Novartis Investigative Site
Tochigi, 329-0498, Japan
Novartis Investigative Site
Tokyo, 145-0065, Japan
Novartis Investigative Site
Tokyo, 162-8666, Japan
Novartis Investigative Site
Wakayama, 641-8510, Japan
Related Publications (2)
Saida T, Itoyama Y, Kikuchi S, Hao Q, Kurosawa T, Ueda K, Auberson LZ, Tsumiyama I, Nagato K, Kira JI. Long-term efficacy and safety of fingolimod in Japanese patients with relapsing multiple sclerosis: 3-year results of the phase 2 extension study. BMC Neurol. 2017 Jan 28;17(1):17. doi: 10.1186/s12883-017-0794-5.
PMID: 28129749DERIVEDSaida T, Kikuchi S, Itoyama Y, Hao Q, Kurosawa T, Nagato K, Tang D, Zhang-Auberson L, Kira J. A randomized, controlled trial of fingolimod (FTY720) in Japanese patients with multiple sclerosis. Mult Scler. 2012 Sep;18(9):1269-77. doi: 10.1177/1352458511435984. Epub 2012 Feb 21.
PMID: 22354739DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- PRINCIPAL INVESTIGATOR
Novartis Pharmaceuticals, Japan
+81 3 3797 8748
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 26, 2007
First Posted
September 28, 2007
Study Start
September 1, 2007
Primary Completion
February 1, 2010
Last Updated
April 21, 2011
Results First Posted
March 23, 2011
Record last verified: 2011-04