Safety and Efficacy of Fingolimod in MS Patients in China

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2017-05-31

Brief Summary

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To evaluate the safety and efficacy of fingolimod 0.5mg vs. placebo in MS patients in China

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Detailed Description

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Conditions

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Multiple Sclerosis (Relapsing Remitting)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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double blinded Fingolimod 6 mos + open label fingolimod 6 mos

Randomized to 6 month (180 days) 0.5 mg fingolimod + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily

Group Type EXPERIMENTAL

fingolimod

Intervention Type DRUG

Randomized to 6 month (180 days) 0.5 mg fingolimod + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily

Placebo 6 mos + open label fingolimod 6 mos

Randomized to 6 month (180 days) matching placebo + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily

Group Type PLACEBO_COMPARATOR

Placebo (6mos) + open label fingolimod (6 mos)

Intervention Type DRUG

Randomized to 6 month (180 days) matching placebo + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily

Interventions

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fingolimod

Randomized to 6 month (180 days) 0.5 mg fingolimod + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily

Intervention Type DRUG

Placebo (6mos) + open label fingolimod (6 mos)

Randomized to 6 month (180 days) matching placebo + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

-Patients must have relapsing remitting multiple sclerosis

Exclusion Criteria

Patients with:

* History of chronic immune disease
* Certain cancers
* Uncontrolled diabetes
* Certain eye disorders -Negative for varicella
* zoster virus IgG antibodies
* Certain hepatic conditions
* Low white blood cell count
* On certain immunosuppressive medications or heart medications
* Certain heart conditions or certain lung conditions
* Inability to undergo MRI scans -Diagnosis of Neuromyelitis optica.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No