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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fingolimod

Open-label fingolimod 0.5 mg, taken orally once daily for 4 months

Group Type EXPERIMENTAL

Fingolimod

Intervention Type DRUG

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

Interventions

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Fingolimod

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No