evaluate efficacy and safety of fingolimod 0.5 mg orally once daily versus placebo in chronic inflammatory demyelinating polyradiculoneuropathy patients.

Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Summary: 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.

Eligibility criteria:
inclusion criteria * written informed consent must be obtained before any assessment is performed * the diagnosis of cidp will use the definition of the efns/pns task force first revision. patients must either have a clinical diagnosis of cidp fulfilling the clinical inclusion criteria for typical cidp or one of the following atypical forms of cidp: pure motor, or asymmetrical (madsam \[lewis-sumner syndrome\]), or iga or igg (not igm) mgus paraprotein associated. * all patients must also fulfill the clinical exclusion criteria and the definite electrodiagnostic criteria of the efns/pns task force first revision. * disability defined by an incat disability scale score of 1-9 or, if incat score is 0, a documented history of disability sufficient to require treatment within the past 2 years following reduction or interruption of cidp treatment * receiving ivig treatment (minimal dose equivalent to 0.4 g/kg every 4 weeks for a minimum of 12 weeks) or corticosteroids (minimal dose equivalent to prednisone 10 mg/day) treatment prior to the screening visit * history of documented clinically meaningful deterioration confirmed by clinical examination during therapy or upon interruption or reduction of therapy within 18 months prior to screening * stable cidp symptoms for the 6 weeks before randomization exclusion criteria * other chronic demyelinating neuropathies, including: distal acquired demyelinating symmetric neuropathy (dads) multifocal motor neuropathy (mmn) pure sensory cidp hematopoietic malignancy except for mgus * conditions in which the pathogenesis of the neuropathy may be different from cidp such as: lyme disease, poems syndrome, osteosclerotic myeloma, castleman's disease * treatment with plasma exchange within 2 months of randomization, immunosuppressive/chemotherapeutic medications: azathioprine, cyclophosphamide, cyclosporine, mycophenolate, etanercept, methotrexate tacrolimus or other immunosuppressive drugs within 6 months of randomization or 5 half-lives (whichever is later), rituximab in the 2 years prior to randomization (patients that have received rituximab between 1 and 2 years should have b-cell levels within normal range), other cytotoxic immunosuppressive medications with sustained effects (including mitoxantrone, alemtuzumab, cladribine) at any time, hematopoietic stem cell transplantation at any time

Keywords: chronic inflammatory demyelinating polyradiculoneuropathy, cidp, fty720, fingolimod.