Safety and Tolerability of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis

Phase 3

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: Fingolimod

• Registration Number: NCT01497262
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-05
• Study First Submitted QC: 2011-12-19
• Study First Posted: 2011-12-22
• Study Start: 2012-02
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Results First Submitted: 2015-02-26
• Status Verified: 2015-03
• Results First Submitted QC: 2015-03-17
• Last Update Submitted: 2015-03-17
• Results First Posted: 2015-03-19
• Last Update Posted: 2015-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fingolimod	Fingolimod	Open-label fingolimod 0.5 mg, taken orally once daily for 4 months

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events as a Measure of Safety and Tolerability	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 Outcome Measures

Name	Time	Method
Number (%) of Patients With AE of Special Interest Including Bradyarrhythmia, BP Increase, Liver Transaminase Elevations, Infections , Macula Oedema.	4 months	The incidence of events in special areas of safety interest (including bradyarrhythmias, BP increase, liver function, infections and macular oedema) were assessed by the nature and frequency of AE reporting. These areas of special interest have been identified and potential risks of fingolimod based on knowledge from clinical trials and post-marketing reporting.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇵🇪 San Isidro, Lima, Peru