NCT01497262

Brief Summary

This 4 month, open-label study will evaluate the safety and tolerability of fingolimod 0.5 mg in patients with relapsing-remitting multiple sclerosis (RRMS) and generate additional data in Multiple Sclerosis (MS) patient population that closely resembles the clinical population seen in routine medical care.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
162

participants targeted

Target at P25-P50 for phase_3 multiple-sclerosis

Timeline
Completed

Started Feb 2012

Geographic Reach
8 countries

29 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

First Submitted

Initial submission to the registry

December 5, 2011

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 22, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
12 months until next milestone

Results Posted

Study results publicly available

March 19, 2015

Completed
Last Updated

March 19, 2015

Status Verified

March 1, 2015

Enrollment Period

2.2 years

First QC Date

December 5, 2011

Results QC Date

February 26, 2015

Last Update Submit

March 17, 2015

Conditions

Multiple Sclerosis

Keywords

Multiple SclerosisRelapsing-Remitting

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Adverse Events as a Measure of Safety and Tolerability

    Any Adverse Event was defined as occurrence of any symptom regardless of intensity grade, Serious Adverse Event (SAEs) assessed as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in persistent or significant disability/incapacity

    28 weeks

Secondary Outcomes (1)

  • Number (%) of Patients With AE of Special Interest Including Bradyarrhythmia, BP Increase, Liver Transaminase Elevations, Infections , Macula Oedema.

    4 months

Study Arms (1)

Fingolimod

EXPERIMENTAL

Open-label fingolimod 0.5 mg, taken orally once daily for 4 months

Drug: Fingolimod

Interventions

FingolimodDRUG

Fingolimod will be supplied as 0.5mg capsules in bottles of 35.

Fingolimod

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with relapsing remitting Multiple Sclerosis
  • Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5.

You may not qualify if:

  • Patients with MS other than relapsing remitting MS
  • Patients with a history of chronic disease of the immune system other than MS, which requires systemic immunosuppressive treatment, or a known immunodeficiency syndrome.
  • Patients who have been treated with:
  • systemic corticosteroids or immunoglobulins within 1 month prior to baseline;
  • immunosuppressive medications within 3 months prior to baseline;
  • monoclonal antibodies within 3 months prior to baseline;
  • cladribine, mitoxantrone or alemtuzumab at any time.
  • Uncontrolled diabetes mellitus at screening
  • Diagnosis of macular edema during Screening Phase
  • Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or to have positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests.
  • Patients who have received total lymphoid irradiation or bone marrow transplantation.
  • Patients with certain cardiovascular conditions and/or findings in the screening ECG
  • Patients with certain liver conditions
  • Pregnant confirmed by a positive pregnancy test t or nursing (lactating) women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

Novartis Investigative Site

Caba, Buenos Aires, 1425, Argentina

Location

Novartis Investigative Site

Villa Nueva, Mendoza Province, M5507XAD, Argentina

Location

Novartis Investigative Site

Salta, Salta Province, A4400ANG, Argentina

Location

Novartis Investigative Site

Salta, Salta Province, A4400BKZ, Argentina

Location

Novartis Investigative Site

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Novartis Investigative Site

San Miguel de Tucumán, Tucumán Province, T4000DPB, Argentina

Location

Novartis Investigative Site

Córdoba, X5004CDT, Argentina

Location

Novartis Investigative Site

Rio de Janeiro, Rio de Janeiro, 20270-004, Brazil

Location

Novartis Investigative Site

Rio de Janeiro, Rio de Janeiro, 21941-590, Brazil

Location

Novartis Investigative Site

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Novartis Investigative Site

Barranquilla, Atlántico, Colombia

Location

Novartis Investigative Site

Bogotá, Cundinamarca, 110111, Colombia

Location

Novartis Investigative Site

Bogotá, 00000, Colombia

Location

Novartis Investigative Site

Bogotá, Colombia

Location

Novartis Investigative Site

Cali, Colombia

Location

Novartis Investigative Site

Amman, Amman Governorate, 11942, Jordan

Location

Novartis Investigative Site

Irbid, 22110, Jordan

Location

Novartis Investigative Site

Kuala Lumpur, Kuala Lumpur, 50586, Malaysia

Location

Novartis Investigative Site

George Town, Pulau Pinang, 10990, Malaysia

Location

Novartis Investigative Site

Kuala Lumpur, 59100, Malaysia

Location

Novartis Investigative Site

Mexico City, Mexico City, 06700, Mexico

Location

Novartis Investigative Site

Mexico City, Mexico City, 10700, Mexico

Location

Novartis Investigative Site

Monterrey, Nuevo León, 64060, Mexico

Location

Novartis Investigative Site

San Nicolás de los Garza, Nuevo León, 66480, Mexico

Location

Novartis Investigative Site

San Luis Potosí City, San Luis Potosí, 78240, Mexico

Location

Novartis Investigative Site

Panama City, Provincia de Panamá, Panama

Location

Novartis Investigative Site

Jesus Maria, Lima region, 11, Peru

Location

Novartis Investigative Site

San Isidro, Lima region, 27, Peru

Location

Novartis Investigative Site

La Perla, Provincia Constitucional del Callao, 04, Peru

Location

Related Publications (1)

  • Ordonez-Boschetti L, Rey R, Cruz A, Sinha A, Reynolds T, Frider N, Alvarenga R. Safety and Tolerability of Fingolimod in Latin American Patients with Relapsing-Remitting Multiple Sclerosis: The Open-Label FIRST LATAM Study. Adv Ther. 2015 Jul;32(7):626-35. doi: 10.1007/s12325-015-0224-2. Epub 2015 Jul 14.

    PMID: 26170105DERIVED

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 DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2011

First Posted

December 22, 2011

Study Start

February 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

March 19, 2015

Results First Posted

March 19, 2015

Record last verified: 2015-03

Locations

PE(3)MY(3)AR(7)CO(5)JO(2)ME(5)BR(3)PA(1)