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

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Inflammatory Demyelinating Polyradiculoneuropathy

In brief

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

Key facts

Study ID

NCT01625182

Run by

Novartis Pharmaceuticals

People needed

106

Starts

2012-12-22

Expected to finish

2016-09-03

Last updated by the study team

2017-10-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Miami, Florida, United States
• Novartis Investigative Site — St. Petersburg, Florida, United States
• Novartis Investigative Site — Chicago, Illinois, United States
• Novartis Investigative Site — Louisville, Kentucky, United States
• Novartis Investigative Site — Boston, Massachusetts, United States
• Novartis Investigative Site — New York, New York, United States
• Novartis Investigative Site — Patchogue, New York, United States
• Novartis Investigative Site — Plainview, New York, United States
• Novartis Investigative Site — Columbus, Ohio, United States
• Novartis Investigative Site — Houston, Texas, United States
• Novartis Investigative Site — Burlington, Vermont, United States
• Novartis Investigative Site — Sydney, New South Wales, Australia
• Novartis Investigative Site — Auchenflower, Queensland, Australia
• Novartis Investigative Site — Fitzroy, Victoria, Australia
• Novartis Investigative Site — Parkville, Victoria, Australia
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Leuven, Belgium
• Novartis Investigative Site — Liège, Belgium
• Novartis Investigative Site — Kingston, Ontario, Canada
• Novartis Investigative Site — Québec, Quebec, Canada
• Novartis Investigative Site — Greenfield Park, Canada
• Novartis Investigative Site — Montreal, Canada
• Novartis Investigative Site — Prague, Czechia
• Novartis Investigative Site — Limoges, France
• Novartis Investigative Site — Orange, California, United States

Full record on ClinicalTrials.gov

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