|Sponsor / Funder||Novartis|
|CI||Dr Michael Lunn|
|UK sites||London Queen Square|
This is a double-blind, randomised, multicentre,
placebo-controlled, parallel-group study in patients with a confirmed diagnosis
Patients must be treated with IVIg, corticosteroids, or both therapies before study entry. Eligible patients will be randomised in a 1:1 ratio to receive oral Fingolimod (0.5 mg/day) or placebo.
To evaluate the efficacy and safety of Fingolimod in the treatment of CIDP.
Data from this study will be used to support the registration of Fingolimod for treatment of CIDP.
The study will consist of 3 periods:
- a screening period (lasting for up to 45 days)
- a double-blind treatment period (variable duration)
- and a follow-up period after discontinuation of study drug treatment
The duration of this study is flexible, based on pre-specified rules.
The trial should not exceed approximately three years.
Patients who complete the study will have an option to enter an extension study.