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OpenTrials
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NCT Number: NCT01497262

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Caba, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fingolimod

Drug

Fingolimod will be supplied as 0.5mg capsules in bottles of 35.

Primary outcomes

  1. 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

  1. Number (%) of Patients With AE of Special Interest Including Bradyarrhythmia, BP Increase, Liver Transaminase Elevations, Infections , Macula Oedema.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 22, 2011
Registry last updated
Mar 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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