NCT00333138

Brief Summary

This study evaluated the safety, tolerability and effect on MRI lesion parameters of FTY720 in patients with relapsing multiple sclerosis.

Trial Health

98
On Track

Trial Health Score

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

Enrollment
281

participants targeted

Target at P75+ for phase_2 multiple-sclerosis

Timeline
Completed

Started May 2003

Longer than P75 for phase_2 multiple-sclerosis

Geographic Reach
11 countries

26 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

May 1, 2003

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2006

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

October 30, 2012

Completed
Last Updated

September 15, 2017

Status Verified

August 1, 2017

Enrollment Period

7.9 years

First QC Date

June 1, 2006

Results QC Date

April 5, 2012

Last Update Submit

August 17, 2017

Conditions

Multiple Sclerosis

Keywords

FTY720MSMultiple SclerosisRRMS

Outcome Measures

Primary Outcomes (4)

  • Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core)

    Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis.

    Month 6 (Core)

  • Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 12

    Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis.

    Month 12 (extension)

  • Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 60

    Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis.

    Month 60 (extension)

  • Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at End of Study

    Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis. The last observation was the last observation available for each patient which ranged from 1 to 2801 days

    Last observation (Up to 80 months in average)

Secondary Outcomes (7)

  • Percentage of Participants Free of T1-weighted Lesions

    Baseline, Months 6 (core), 12, 60 and Last Observation (up to 80 months in average)

  • Percentage of Patients Free of Gd-enhanced T1-weighted and New T2- Weighted Lesions by Visit

    Month 6 and 12, 60, last observation (up to 80 months in average)

  • Mean Number of New T2-weighted Lesions

    (Core) Month 6 and (Extension) 12, 60, last observation (up to 80 months in average)

  • Volume of T2-weighted Lesions

    (Core) Month 6 and (Extension) 12, 60, last observation (up to 80 months in average)

  • Change From Baseline in Volume of Total T2-weighted Lesions

    Baseline to month 6, 12, 60 and Last observation (up to 80 months in average)

  • +2 more secondary outcomes

Study Arms (3)

Fingolimod (FTY720) 1.25 mg/day

EXPERIMENTAL

Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.

Drug: FTY720

Placebo/Fingolimod (FTY720)

PLACEBO COMPARATOR

Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.

Drug: Placebo

Fingolimod (FTY720) 5.0 mg/day

EXPERIMENTAL

Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 15 to 24 months 1.25mg once daily. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.

Drug: FTY720

Interventions

FTY720DRUG

FTY720 capsule was taken orally once a day

Fingolimod (FTY720) 1.25 mg/dayFingolimod (FTY720) 5.0 mg/day
PlaceboDRUG

Placebo 1.25 mg capsule was given once daily

Placebo/Fingolimod (FTY720)

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of relapsing multiple Sclerosis (MS)
  • Patients with at least two documented relapses in the previous 2 years or one documented relapse in the last year
  • Patients with an Expanded Disability Status Scale (EDSS) score of 0-6
  • Extension Study
  • A positive Gd-enhanced MRI scan at screening (in case the first MRI scan obtained at screening was negative, a second scan could have been obtained 1 month later)
  • Neurologically stable with no evidence of relapse within 30 days prior to randomization,or during the Screening and Baseline periods.
  • Female patients either post-menopausal, surgically incapable of bearing children, or practicing an acceptable method of birth control. Females of childbearing potential with a negative pregnancy test at baseline prior to entry into the treatment period.

You may not qualify if:

  • Core Study
  • Patients with other chronic disease of the immune system, malignancies, pulmonary or heart disease, etc
  • Pregnant or nursing women
  • Extension Study
  • Patients who had permanently discontinued study drug prior to the Month 6 visit of the core study
  • Patients with diabetes mellitus (to reduce the risk of ME), and therefore ongoing patients with diabetes mellitus or who developed diabetes mellitus were discontinued from the study)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Novartis Investigational site

Montreal, Canada

Location

Novartis Investigational site

Ottawa, Canada

Location

Novartis Investigational site

Toronto, Canada

Location

Novartis Investigational site

Vancouver, Canada

Location

Novartis Investigational site

Copenhagen, Denmark

Location

Novartis Investigational site

Helsinki, Finland

Location

Novartis Investigational site

Turku, Finland

Location

Novartis Investigational site

Lille, France

Location

Novartis Investigational site

Marseille, France

Location

Novartis Investigational site

Schwendi, Germany

Location

Novartis Investigational site

Würzburg, Germany

Location

Novartis Investigational site

Gallarate, Italy

Location

Novartis Investigational site

Genova, Italy

Location

Novartis Investigational site

Milan, Italy

Location

Novartis Investigational site

Roma, Italy

Location

Novartis Investigational site

Warsaw, Poland

Location

Novartis Investigational site

Coimbra, Portugal

Location

Novartis Investigational site

Lisbon, Portugal

Location

Novartis Investigational site

Barcelona, Spain

Location

Novartis Investigational site

Madrid, Spain

Location

Novartis Investigational site

Málaga, Spain

Location

Novartis Investigational site

Seville, Spain

Location

Novartis Investigational site

Valencia, Spain

Location

Novartis Investigational site

Basel, Switzerland

Location

Novartis Investigational site

Zurich, Switzerland

Location

Novartis Investigational site

Newcastle upon Tyne, United Kingdom

Location

Related Publications (2)

  • Zarbin MA, Jampol LM, Jager RD, Reder AT, Francis G, Collins W, Tang D, Zhang X. Ophthalmic evaluations in clinical studies of fingolimod (FTY720) in multiple sclerosis. Ophthalmology. 2013 Jul;120(7):1432-9. doi: 10.1016/j.ophtha.2012.12.040. Epub 2013 Mar 24.

    PMID: 23531349DERIVED

  • Kappos L, Antel J, Comi G, Montalban X, O'Connor P, Polman CH, Haas T, Korn AA, Karlsson G, Radue EW; FTY720 D2201 Study Group. Oral fingolimod (FTY720) for relapsing multiple sclerosis. N Engl J Med. 2006 Sep 14;355(11):1124-40. doi: 10.1056/NEJMoa052643.

    PMID: 16971719DERIVED

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

    Novartis Pharmaceuticals

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

June 1, 2006

First Posted

June 2, 2006

Study Start

May 1, 2003

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

September 15, 2017

Results First Posted

October 30, 2012

Record last verified: 2017-08

Locations

IT(4)DE(2)PT(2)CA(4)ES(5)FI(2)CH(2)GB(1)FR(2)DK(1)PL(1)