Phase II/III in fingolimod vs placebo in patients with CIDP
Research type
Research Study
Full 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)
IRAS ID
108941
Contact name
John Winer
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2011-005280-24
Clinicaltrials.gov Identifier
Research summary
Chronic inflammatory demyelinating polyneuropathy (CIDP) isa rare disorder of the nervous system in which there is inflammation of nerve roots and peripheral nerves and destruction of the fatty protective covering (myelin sheath) over the nerves. This disorder causes weakness, paralysis and/or impairment in motor function (the ability to use and control muscles and movements), especially of the arms and legs (limbs). Sensory loss may also be present causing numbness, tingling, or prickling sensations. Current treatments for CIDP have either only short term benefits (intravenous immunoglobulin IVIg), or long term complications (steroids), and new treatments which are easier to take and are safer for long term treatment are required. Fingolimod is a capsule taken by mouth, approved for treating multiple sclerosis (MS), a condition with some similarities to CIDP. The purpose of this study is to measure how safe and how well tolerated fingolimod is in patients with CIDP. Each patient who signs consent and meets inclusion criteria will undergo examinations to determine if they are eligible to join the study. Eligible patients who agree to participate will stop their current medication and be assigned (by chance, like the flip of a coin) to either fingolimod or placebo (dummy pill). Neither patients nor doctors will know which treatment has been assigned. Eligible patients will attend a maximum of 18 visits and have various tests to assess their health and how the medication is working. Tests will include eye and skin examinations, height, weight, blood pressure and heart rate, checks of heart function, blood and urine tests, and patient questionnaires.The study is expected to last up to three years. At the end of the study patients will be given the option to enter an extension study, in which all patients will receive fingolimod.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
12/WM/0268
Date of REC Opinion
25 Sep 2012
REC opinion
Favourable Opinion