Evaluate Efficacy and Safety of Fingolimod 0.5 mg Orally Once Daily Versus Placebo in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients.
Condition: Chronic Inflammatory Demyelinating Polyradiculoneuropathy
MeSH terms: Polyradiculoneuropathy; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Intervention: Fingolimod; Placebo Comparator
Intervention description: Fingolimod 0.5 mg capsules; Matching placebo capsules
Intervention MeSH terms: Fingolimod Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 106.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: chronic inflammatory demyelinating polyradiculoneuropathy, CIDP, FTY720, fingolimod.

Summary:

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

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