Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis (MS)

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00537082
• Other study ID #: CFTY720D1201
• Status: Completed
• Phase: Phase 2
• First received: September 26, 2007
• Last updated: April 19, 2011
• Start date: September 2007

Study information

• Verified date: April 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Male and female patients aged 18-60

• Patients with a diagnosis of multiple sclerosis

Exclusion Criteria:

• 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

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• FTY720
Administered orally once daily for 6 months
• Placebo
Administered orally once daily for 6 months

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Chiba
Japan	Novartis Investigative Site	Ehime
Japan	Novartis Investigative Site	Fukuoka
Japan	Novartis Investigative Site	Gunma
Japan	Novartis Investigative Site	Hyogo
Japan	Novartis Investigative Site	Ibaraki
Japan	Novartis	Iwate
Japan	Novartis Investigative Site	Kanagawa
Japan	Novartis Investigative Site	Kyoto
Japan	Novartis Investigative Site	Kyoto
Japan	Novartis Investigative Site	Niigata
Japan	Novartis Investigative Site	Osaka
Japan	Novartis Investigative Site	Osaka
Japan	Novartis Investigative site	Sapporo-shi	Hokkaido
Japan	Novartis Investigative Site	Tochigi
Japan	Novartis Investigative Site	Tokyo
Japan	Novartis Investigative Site	Tokyo
Japan	Novartis Investigative Site	Wakayama

Sponsors (2)

Lead Sponsor	Collaborator
Novartis	Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of Patients Free of MS Relapse up to Month 6 (Confirmed Relapse Only)	A relapse must have been confirmed by a neurologist and was confirmed when it was accompanied by an increase of at least half a step (0.5) on the Expanded Disability Status Scale (EDSS) or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS).	up to Month 6	No
Secondary	Number of Patients Free of New or Newly Enlarged T2 Lesions	The number of T2 lesions were obtained from MRI scans at Screening visit. The numbers of new/newly enlarging T2 lesions were obtained from MRI scans at Month 3 or more. New lesions were identified by comparing each lesion already seen in previous examinations. Lesions expanding throughout several slices were counted as only one lesion.	up to Month 3 and up to Month 6	No
Secondary	Annualized Relapse Rate (ARR) at 6 Months	Annualized relapse rate (ARR) of the treatment group is calculated by taking the total number of confirmed relapses for all the patients in the treatment group divided by the total number of days on study for all patients in the group and multiplied by 365.25 to obtain the annual rate.	6 Months	No