This trial is active, not recruiting.

Condition chronic inflammatory demyelinating polyradiculoneuropathy
Treatments fingolimod, placebo comparator
Phase phase 3
Sponsor Novartis Pharmaceuticals
Collaborator Mitsubishi Tanabe Pharma Corporation
Start date December 2012
End date September 2016
Trial size 106 participants
Trial identifier NCT01625182, 2011-005280-24, CFTY720I2201


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Placebo Comparator)
placebo comparator

Primary Outcomes

time to first confirmed worsening on the adjusted INCAT Disability Scale by 1 point or more from the value at Baseline, in patients who being treated with IVIg and/or corticosteroids prior to the study start.
time frame: Month 36

Secondary Outcomes

The change from Baseline for grip strength
time frame: Month 6/ Month 36
The change from Baseline for Rasch-Built Linearly Weighted Overall Disability Scale (R-ODS)
time frame: Month 6/ Month 36
safety and tolerability of fingolimod compared with placebo in patients with CIDP
time frame: Month 36

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official 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)
Description This study is 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 will be randomly assigned in a ratio of 1:1 to receive oral fingolimod (0.5 mg/day) or matching placebo. The study will consist 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Novartis.