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

This study has been completed.
Mitsubishi Tanabe Pharma Corporation
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: June 19, 2012
Last updated: May 23, 2017
Last verified: May 2017
The study was designed to evaluate the efficacy and safety of fingolimod in the treatment of chronic inflammatory demyelinating polyradiculoneuropathy compared with placebo.

Condition Intervention Phase
Chronic Inflammatory Demyelinating Polyradiculoneuropathy Drug: Fingolimod Drug: Placebo Comparator Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, 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)

Resource links provided by NLM:

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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

Enrollment: 106
Actual Study Start Date: December 20, 2012
Study Completion Date: September 1, 2016
Primary Completion Date: September 1, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fingolimod 0.5mg/day Drug: Fingolimod
Fingolimod 0.5 mg capsules to be taken orally once daily
Placebo Comparator: Placebo Drug: Placebo Comparator
Matching placebo capsules to be taken orally once daily

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.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01625182

  Show 67 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Mitsubishi Tanabe Pharma Corporation
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals Identifier: NCT01625182     History of Changes
Other Study ID Numbers: CFTY720I2201
2011-005280-24 ( EudraCT Number )
Study First Received: June 19, 2012
Last Updated: May 23, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
chronic inflammatory demyelinating polyradiculoneuropathy, CIDP, FTY720, fingolimod.

Additional relevant MeSH terms:
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases
Fingolimod Hydrochloride
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on August 16, 2017