Evaluate Efficacy and Safety of Fingolimod 0.5 mg Orally Once Daily Versus Placebo in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients.

Phase 3 Completed 106 enrolled Novartis Pharmaceuticals Tanabe Pharma Corporation · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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

Timeline

Start: 2012-12-22
Primary completion: 2016-09-03
Completion: 2016-09-03

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Fingolimod (FTY720) vs Placebo; p = 0.9838; Hazard Ratio (HR) 1.0 (95% CI 0.6 to 1.7); Regression, Cox NCT01625182 ↗

paper Fingolimod 0·5 mg once-daily was not better than placebo for the treatment of CIDP. PMID 30001923 ↗

Publications

Hughes R, Dalakas MC, Merkies I, Latov N, Leger JM, Nobile-Orazio E, Sobue G, Genge A, Cornblath D, Merschhemke M, Ervin CM, Agoropoulou C, Hartung HP; FORCIDP Trial Investigators. Oral fingolimod for chronic inflammatory demyelinating polyradiculoneuropathy (FORCIDP Trial): a double-blind, multicentre, randomised controlled trial. Lancet Neurol. 2018 Aug;17(8):689-698. doi: 10.1016/S1474-4422(18)30202-3. Epub 2018 Jul 9.

Drugs