Status:
COMPLETED
Safety and Tolerability of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 Sc...
Eligibility Criteria
Inclusion
- Patients with relapsing remitting Multiple Sclerosis
- Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5.
Exclusion
- 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
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT01497262
Start Date
February 1 2012
End Date
April 1 2014
Last Update
March 19 2015
Active Locations (29)
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1
Novartis Investigative Site
Caba, Buenos Aires, Argentina, 1425
2
Novartis Investigative Site
Villa Nueva, Mendoza Province, Argentina, M5507XAD
3
Novartis Investigative Site
Salta, Salta Province, Argentina, A4400ANG
4
Novartis Investigative Site
Salta, Salta Province, Argentina, A4400BKZ