NCT00670449

Brief Summary

This study was an extension study of NCT00537082. This study was designed to evaluate the efficacy and safety of long-term administration of 0.5 mg or 1.25 mg of fingolimod (FTY720) to relapsing multiple sclerosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P75+ for phase_2 multiple-sclerosis

Timeline
Completed

Started Apr 2008

Typical duration for phase_2 multiple-sclerosis

Geographic Reach
1 country

20 active sites

Status
completed

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

April 1, 2008

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

April 28, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 1, 2008

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

September 4, 2013

Completed
Last Updated

September 4, 2013

Status Verified

June 1, 2013

Enrollment Period

4 years

First QC Date

April 28, 2008

Results QC Date

March 8, 2013

Last Update Submit

June 26, 2013

Conditions

Multiple Sclerosis

Keywords

FTY720multiple sclerosisMS

Outcome Measures

Primary Outcomes (1)

  • Percentage of Patients Free of Gd-enhanced T1 Weighted Magnetic Resonance Imaging (MRI) Lesions

    To ensure consistency, MRI scans were evaluated centrally at the Institute of Neurotherapeutics in Kyoto, Japan. After checking the scans for completeness and quality, all scans were analyzed by blinded readers (experienced neurologists). The number of Gd-enhanced T1 weighted MRI lesions were counted and recorded. Lesions expanding through several slices were counted as only 1 lesion.

    Months 6, 9, 12, 18, 24, 36, and 48

Secondary Outcomes (5)

  • Percentage of Patients Free of New or Newly Enlarged T2 Weighted MRI Lesions

    Months 0-3, 3-6, 6-9, 9-12, 12-18, 18-24, 24-36,36-48, and 48 to the end of the study (up to 4 years)

  • Aggregate Annualized Relapse Rate (ARR) Based on Confirmed Relapses

    Months 0-6, 6-12, 12-24, 24-36, 36-48, and 48 to the end of the study (up to 4 years)

  • Percentage of Patients Relapse-free at the End of the Study

    Baseline to the end of the study (up to 4 years)

  • Percentage of Patients Free From 3-month and 6-month Confirmed Disability Progression at Their Last Expanded Disability Status Scale (EDSS) Assessment

    Baseline to the end of the study (up to 4 years)

  • Change From Core Study Baseline in the Expanded Disability Status Scale (EDSS) Score

    Baseline to Months 12, 24, 36, 48, and end of study (up to 4 years)

Study Arms (3)

Fingolimod 0.5 mg

EXPERIMENTAL

Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.

Drug: Fingolimod

Fingolimod 1.25 mg

EXPERIMENTAL

Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.

Drug: Fingolimod

Placebo-fingolimod

EXPERIMENTAL

Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.

Drug: Fingolimod

Interventions

FingolimodDRUG

Fingolimod was supplied in capsules.

Also known as: Gilenya, Imsera
Fingolimod 0.5 mgFingolimod 1.25 mgPlacebo-fingolimod

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients who completed 6 months of treatment with the study drug and the Month 6 visit in the core study NCT00537082.
  • Females of childbearing potential who have a negative pregnancy test in the core study NCT00537082.

You may not qualify if:

  • Patients who permanently discontinued study drug treatment prior to the Month 6 visit in the core study NCT00537082.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Novartis Investigative Site

Chiba, 276-8524, Japan

Location

Novartis Investigative Site

Ehime, 791-0295, Japan

Location

Novartis Investigative Site

Fukuoka, 807-8555, Japan

Location

Novartis Investigative Site

Gunma, 371-8511, Japan

Location

Novartis Investigative Site

Hyōgo, 650-0017, Japan

Location

Novartis Investigative Site

Ibaraki, 305-8576, Japan

Location

Novartis Investigative Site

Kanagawa, 259-1193, Japan

Location

Novartis Investigative Site

Kyoto, 604-8453, Japan

Location

Novartis Investigative Site

Kyoto, 616-8255, Japan

Location

Novartis Investigative Site

Morioka, 020-8505, Japan

Location

Novartis Investigative Site

Niigata, 951-8520, Japan

Location

Novartis Investigative Site

Osaka, 556-0016, Japan

Location

Novartis Investigative Site

Osaka, 589-8511, Japan

Location

Novartis Investigative Site

Osaka, Japan

Location

Novartis Investigative Site

Sapporo, 060-8648, Japan

Location

Novartis Investigative Site

Tochigi, 329-0498, Japan

Location

Novartis Investigative Site

Tokyo, 113-8519, Japan

Location

Novartis Investigative Site

Tokyo, 145-0065, Japan

Location

Novartis Investigative Site

Tokyo, 162-8666, Japan

Location

Novartis Investigative Site

Wakayama, 641-8510, Japan

Location

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: 28129749DERIVED

  • Kira J, Itoyama Y, Kikuchi S, Hao Q, Kurosawa T, Nagato K, Tsumiyama I, von Rosenstiel P, Zhang-Auberson L, Saida T. Fingolimod (FTY720) therapy in Japanese patients with relapsing multiple sclerosis over 12 months: results of a phase 2 observational extension. BMC Neurol. 2014 Jan 29;14:21. doi: 10.1186/1471-2377-14-21.

    PMID: 24475777DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Fingolimod Hydrochloride

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

SphingosineAmino AlcoholsAlcoholsOrganic ChemicalsPropylene GlycolsGlycolsAmines

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
862 778-8300

Study Officials

  • Novartis Pharmaceuticals, Japan

    81-3-3797-8748

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2008

First Posted

May 1, 2008

Study Start

April 1, 2008

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

September 4, 2013

Results First Posted

September 4, 2013

Record last verified: 2013-06

Locations

JP(20)