A 4-month, Open-label, Multi-center Study to Explore the Safety and Tolerability of Fingolimod 0.5 mg in Patients With Relapsing-remitting Multiple Sclerosis

CompletadoFase 3ClinicalTrials.gov

ID: NCT01497262Tipo: INTERVENTIONALInicio: 1 de feb de 2012Fin estimado: 1 de abr de 2014

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 65 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

Fingolimod

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

Ubicaciones

Novartis Investigative Site

Caba, Buenos Aires, Argentina

Novartis Investigative Site

Villa Nueva, Mendoza Province, Argentina

Novartis Investigative Site

Salta, Salta Province, Argentina

Novartis Investigative Site

Salta, Salta Province, Argentina

Novartis Investigative Site

San Miguel de Tucumán, Tucumán Province, Argentina

Novartis Investigative Site

San Miguel de Tucumán, Tucumán Province, Argentina

Novartis Investigative Site

Córdoba, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

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