Evaluate Efficacy and Safety of Fingolimod 0.5 mg Orally Once Daily Versus Placebo in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients.
The study is designed to evaluate the efficacy and safety of fingolimod in the treatment of chronic inflammatory demyelinating polyradiculoneuropathy compared with placebo.
Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Drug: Placebo Comparator
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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)|
- 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 ] [ Designated as safety issue: No ]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.
- The change from Baseline for grip strength [ Time Frame: Month 6/ Month 36 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]Measured by AE/SAE, hematology and biochemistry lab tests, vital signs, ECG, and pulmonary function test
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||November 2016|
|Estimated Primary Completion Date:||November 2016 (Final data collection date for primary outcome measure)|
|Experimental: Fingolimod 0.5mg/day||Drug: Fingolimod|
|Placebo Comparator: Placebo||Drug: Placebo Comparator|
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 study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01625182
|Contact: Novartis Pharmaceuticals||1-888-669-6682|
|Contact: Novartis Pharmaceuticals|
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|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|