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 ]
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