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
Overview
- Phase
- Phase 3
- Intervention
- Fingolimod
- Conditions
- Multiple Sclerosis
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 162
- Locations
- 1
- Primary Endpoint
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with relapsing remitting Multiple Sclerosis
- •Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5.
Exclusion Criteria
- •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.
Arms & Interventions
Fingolimod
Open-label fingolimod 0.5 mg, taken orally once daily for 4 months
Intervention: Fingolimod
Outcomes
Primary Outcomes
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time Frame: 28 weeks
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
Secondary Outcomes
- Number (%) of Patients With AE of Special Interest Including Bradyarrhythmia, BP Increase, Liver Transaminase Elevations, Infections , Macula Oedema.(4 months)