Chronic Inflammatory Demyelinating Polyradiculoneuropathy Clinical Trial
Official title:
A Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Fingolimod 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
The study was designed to evaluate the efficacy and safety of fingolimod in the treatment of chronic inflammatory demyelinating polyradiculoneuropathy compared with placebo.
This study was a double-blind, randomized, multicenter, placebo-controlled, parallel-group
study in patients with a diagnosis of chronic inflammatory demyelinating
polyradiculoneuropathy and treated with IVIg, corticosteroids, or both therapies prior to
study entry. Patients meeting the eligibility criteria were randomly assigned in a ratio of
1:1 to receive oral fingolimod (0.5 mg/day) or matching placebo.
The study consisted of 3 periods: a Screening Period, a Double-blind Treatment Period and a
Follow-up Period after discontinuation of study drug treatment. Patients who complete the
study will have an option to enter an extension.
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|---|---|---|---|
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