Safety and Tolerability of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- The incidence rate of adverse events (AEs and SAEs) [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]
The incidence of AEs (new or worsened from baseline) and suspected study drug related AEs or developed into an SAE after the start of the treatment will be summarized as the frequency count as well as the percentage of patients with AEs by primary system organ class (SOC), preferred term, severity and relationship to study drug.
In addition, the incidence of death, SAEs (including infections), AEs (including infections) leading to premature discontinuation of study drug, and other significant AEs will be summarized separately by primary system organ class and preferred term.
- Incidence of cardiovascular (bradyarrhythmias and blood pressure increase) events during the first dose administration [ Time Frame: 1,2,3,4,5 and 6 hours ] [ Designated as safety issue: Yes ]
Incidence of bradyarrhythmias will be assessed based on the AEs. Summary statistics for the incidence of bradyarrhythmias will be reported with the primary analyses.
Incidence of bradyarrhythmias will be assessed up to 6 hours post initial dose. Incidence of blood pressure increase will be assessed using data from the vital signs. The frequencies and percentages of patients with blood pressure increase will be summarized.
- Incidence of liver transaminase elevations [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]Incidence of liver transaminase elevations will be assessed using data from liver function tests. The frequencies and percentages of patients with elevations of 1, 2, 3, 5, and 10 times of the upper limit of normal will be summarized.
- Incidence of infections [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]Incidence of all infections will be assessed based on the AEs. Summary statistics for the incidence of infections will be reported within the primary analyses. Infections will be summarized separately by preferred term.
- Percentage of patient developing macular edema during the study [ Time Frame: Baseline, 16 weeks ] [ Designated as safety issue: Yes ]The incidence of macular edema will be assessed using data from the ophthalmic assessments (including, but not limited to, best-corrected visual acuity, dilated ophthalmoscopy, fundus examination, FA and OCT), and will be summarized as frequency distributions.
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||March 2014|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Open-label fingolimod 0.5 mg, taken orally once daily for 4 months
Fingolimod will be supplied as 0.5mg capsules in bottles of 35.
|Contact: Novartis Pharmaceuticals||+41613241111|
|Contact: Novartis Pharmaceuticals|
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|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|