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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Wit

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

Detailed Summary:

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.


Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: 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 ]

The time to the first confirmed worsening on the adjusted INCAT Disability Scale Score has to be confirmed by the Independent Evaluating Physician at any scheduled or unscheduled visit. The INCAT Disability Scale has been applied to measure disability in inflammatory neuropathies. The INCAT Disability Scale has been demonstrated to possess good clinimetric properties, has proven to correlate well with patients' perception of their disease state, and, importantly, is easily administered and requires minimal training.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The change from Baseline for grip strength [ Time Frame: Month 6/ Month 36 ]
    Grip strength measurements will be done using a vigorimeter. With this device, the pressure in the bulb exercised by the patient is registered on a manometer via a rubber junction tube. The grip strength has been demonstrated to be responsive in various studies examining patients with inflammatory neuropathies.
  • The change from Baseline for Rasch-Built Linearly Weighted Overall Disability Scale (R-ODS) [ Time Frame: Month 6/ Month 36 ]
    This questionnaire was constructed using the patients' perception of their ability to perform daily and social activities. The final questionnaire comprises 24 items ranging from ability to read a book or newspaper (as the easiest item to accomplish) to ability to run (most difficult item to accomplish).
  • safety and tolerability of fingolimod compared with placebo in patients with CIDP [ Time Frame: Month 36 ]
    Measured by AE/SAE, hematology and biochemistry lab tests, vital signs, ECG, and pulmonary function test


Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: June 19, 2012
Date Started: December 2012
Date Completion:
Last Updated: November 11, 2016
Last Verified: November 2016