Safety and Tolerability of Fingolimod in Patients With Relapsing-remit
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
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
Results by group
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
28 weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Fingolimod 0.5 mg | 100 Participants | 162 | |
| Fingolimod 0.5 mg | 12 Participants | 162 | |
| Fingolimod 0.5 mg | 0 Participants | 162 |
Fingolimod 0.5 mg
Fingolimod 0.5 mg
Fingolimod 0.5 mg
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Fingolimod 0.5 mg | 162 | 12 (7.4%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
28 weeks
Safety
Other measures (1)
Number (%) of Patients With AE of Special Interest Including Bradyarrhythmia, BP Increase, Liver Transaminase Elevations, Infections , Macula Oedema.
4 months
Safety
Who could take part
Relapsing MS · 18 to 65 · EDSS 0 to 6.5
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Safety and Tolerability of Fingolimod in Latin American Patients with Relapsing-Remitting Multiple Sclerosis: The Open-Label FIRST LATAM Study.Adv Ther · 2015
Results
Assessment of cardiac safety during fingolimod treatment initiation in a real-world relapsing multiple sclerosis population: a phase 3b, open-label study.J Neurol · 2014
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History
Started
Feb 2012
Main results due
Apr 2014
Finished
Apr 2014
Results posted
Mar 2015