Phase 3
N=162
Safety and Tolerability of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT01497262 ↗Enrolled (actual)
162
Serious AEs
7.4%
Results posted
Mar 2015
Primary outcome: Primary: Number of Participants With Adverse Events as a Measure of Safety and Tolerability — 100; 12; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fingolimod (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events as a Measure of Safety and Tolerability |
100; 12; 0 | — |
| SECONDARY Number (%) of Patients With AE of Special Interest Including Bradyarrhythmia, BP Increase, Liver Transaminase Elevations, Infections , Macula Oedema. |
8.6; 0.6; 2.5; 3.7; 28.4; 0 | — |
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.
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.
- 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.
Data sourced from ClinicalTrials.gov (NCT01497262). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.