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

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Brief Title

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

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)

Brief Summary

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

Detailed Description

      This study was 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 were randomly assigned in a ratio of
      1:1 to receive oral fingolimod (0.5 mg/day) or matching placebo.

      The study consisted 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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Time to First Confirmed Worsening on the Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Scale

Secondary Outcome

 Change From Baseline for Grip Strength, Dominant Hand

Condition

Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Intervention

Fingolimod

Study Arms / Comparison Groups

 Fingolimod (FTY720)
Description:  Participants received Fingolimod 0.5 mg orally once daily.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

106

Start Date

December 22, 2012

Completion Date

September 3, 2016

Primary Completion Date

September 3, 2016

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
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Novartis Pharmaceuticals, , 

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT01625182

Organization ID

CFTY720I2201

Secondary IDs

2011-005280-24

Responsible Party

Sponsor

Study Sponsor

Novartis Pharmaceuticals

Collaborators

 Mitsubishi Tanabe Pharma Corporation

Study Sponsor

Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals


Verification Date

September 2017