Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Keywords: chronic inflammatory demyelinating polyradiculoneuropathy, CIDP, FTY720, fingolimod.
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 106
Healthy volunteers: no

Brief summary:
The study was designed to evaluate the efficacy and safety of fingolimod in the treatment of chronic inflammatory demyelinating polyradiculoneuropathy compared with placebo.

Detailed description:
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.

Arms:
arm 1: Participants received Fingolimod 0.5 mg orally once daily. arm 2: Participants received matching placebo to Fingolimod orally once daily.

Interventions: intervention 1: Fingolimod intervention 2: Placebo Comparator
Intervention descriptions: intervention 1: Fingolimod 0.5 mg capsules intervention 2: Matching placebo capsules

Protocol document: