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

Phase 2

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: FTY720; Drug: Placebo

• Registration Number: NCT00537082
• Lead Sponsor: Novartis

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-09-26
• Study First Submitted QC: 2007-09-27
• Study First Posted: 2007-09-28
• Primary Completion: 2010-02
• Results First Submitted: 2011-02-21
• Results First Submitted QC: 2011-02-22
• Results First Posted: 2011-03-23
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-19
• Last Update Posted: 2011-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 171

Inclusion Criteria

• Male and female patients aged 18-60
• Patients with a diagnosis of multiple sclerosis

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FTY720 1.25 mg	FTY720	FTY720
Placebo	Placebo	-
FTY720 0.5 mg	FTY720	FTY720

Primary Outcome Measures

Name	Time	Method
Number of Patients Free of Gadolinium-enhanced T1-Weighted Magnetic Resonance Imaging (MRI) Lesions at Both Month 3 and Month 6	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.

Secondary Outcome Measures

Name	Time	Method
Number of Patients Free of MS Relapse up to Month 6 (Confirmed Relapse Only)	up to Month 6	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).
Number of Patients Free of New or Newly Enlarged T2 Lesions	up to Month 3 and up to Month 6	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.
Annualized Relapse Rate (ARR) at 6 Months	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.

Trial Locations

Locations (3)

Novartis; 🇯🇵 Iwate, Japan

Novartis Investigative Site; 🇯🇵 Wakayama, Japan

Novartis Investigative site; 🇯🇵 Sapporo-shi, Hokkaido, Japan