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

Back to results

Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

FTY720

Placebo

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring FTY720,, MS

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

FTY720 0.5 mg

FTY720 1.25 mg

Placebo

Arm Description

FTY720

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

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.

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.

Full Information

NCT ID

NCT00537082

First Posted

September 26, 2007

Last Updated

April 19, 2011

Sponsor

Novartis

Collaborators

Mitsubishi Tanabe Pharma Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00537082

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2011

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

February 2010 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Novartis

Collaborators

Mitsubishi Tanabe Pharma Corporation

4. Oversight

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

Keywords

FTY720,, MS

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

171 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FTY720 0.5 mg

Arm Type

Experimental

Arm Description

FTY720

Arm Title

FTY720 1.25 mg

Arm Type

Experimental

Arm Description

FTY720

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

FTY720

Intervention Description

Administered orally once daily for 6 months

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered orally once daily for 6 months

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

Month 3 and Month 6

Secondary Outcome Measure Information:

Title

Number of Patients Free of MS Relapse up to Month 6 (Confirmed Relapse Only)

Description

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).

Time Frame

up to Month 6

Title

Number of Patients Free of New or Newly Enlarged T2 Lesions

Description

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.

Time Frame

up to Month 3 and up to Month 6

Title

Annualized Relapse Rate (ARR) at 6 Months

Description

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.

Time Frame

6 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals, Japan

Organizational Affiliation

+81 3 3797 8748

Official's Role

Principal Investigator

Facility Information:

Facility Name

Novartis Investigative site

City

Sapporo-shi

State/Province

Hokkaido

Country

Japan

Facility Name

Novartis Investigative Site

City

Chiba

ZIP/Postal Code

276-8524

Country

Japan

Facility Name

Novartis Investigative Site

City

Ehime

ZIP/Postal Code

791-0295

Country

Japan

Facility Name

Novartis Investigative Site

City

Fukuoka

ZIP/Postal Code

807-8555

Country

Japan

Facility Name

Novartis Investigative Site

City

Gunma

ZIP/Postal Code

371-8511

Country

Japan

Facility Name

Novartis Investigative Site

City

Hyogo

ZIP/Postal Code

650-0017

Country

Japan

Facility Name

Novartis Investigative Site

City

Ibaraki

ZIP/Postal Code

305-8576

Country

Japan

Facility Name

Novartis

City

Iwate

ZIP/Postal Code

020-8505

Country

Japan

Facility Name

Novartis Investigative Site

City

Kanagawa

ZIP/Postal Code

259-1193

Country

Japan

Facility Name

Novartis Investigative Site

City

Kyoto

ZIP/Postal Code

604-8453

Country

Japan

Facility Name

Novartis Investigative Site

City

Kyoto

ZIP/Postal Code

616-8255

Country

Japan

Facility Name

Novartis Investigative Site

City

Niigata

ZIP/Postal Code

951-8520

Country

Japan

Facility Name

Novartis Investigative Site

City

Osaka

ZIP/Postal Code

556-0016

Country

Japan

Facility Name

Novartis Investigative Site

City

Osaka

ZIP/Postal Code

589-8511

Country

Japan

Facility Name

Novartis Investigative Site

City

Tochigi

ZIP/Postal Code

329-0498

Country

Japan

Facility Name

Novartis Investigative Site

City

Tokyo

ZIP/Postal Code

145-0065

Country

Japan

Facility Name

Novartis Investigative Site

City

Tokyo

ZIP/Postal Code

162-8666

Country

Japan

Facility Name

Novartis Investigative Site

City

Wakayama

ZIP/Postal Code

641-8510

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

28129749

Citation

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.

Results Reference

derived

PubMed Identifier

22354739

Citation

Saida 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.

Results Reference

derived

Multiple Sclerosis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial