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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01625182
Other study ID # CFTY720I2201
Secondary ID 2011-005280-24
Status Completed
Phase Phase 3
First received June 19, 2012
Last updated September 28, 2017
Start date December 22, 2012
Est. completion date September 3, 2016

Study information

Verified date September 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 106
Est. completion date September 3, 2016
Est. primary completion date September 3, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • Chronic Inflammatory Demyelinating Polyradiculoneuropathy
  • Polyradiculoneuropathy
  • Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Intervention

Drug:
Fingolimod
Fingolimod 0.5 mg capsules
Placebo Comparator
Matching placebo capsules

Locations

Country Name City State
Australia Novartis Investigative Site Auchenflower Queensland
Australia Novartis Investigative Site Fitzroy Victoria
Australia Novartis Investigative Site Parkville Victoria
Australia Novartis Investigative Site Sydney New South Wales
Belgium Novartis Investigative Site Bruxelles
Belgium Novartis Investigative Site Leuven
Belgium Novartis Investigative Site Liege
Canada Novartis Investigative Site Greenfield Park
Canada Novartis Investigative Site Kingston Ontario
Canada Novartis Investigative Site Montreal
Canada Novartis Investigative Site Québec Quebec
Czechia Novartis Investigative Site Praha 5
France Novartis Investigative Site Limoges
France Novartis Investigative Site Marseille cedex 05
France Novartis Investigative Site Montpellier
France Novartis Investigative Site Paris
France Novartis Investigative Site Pessac Cedex
France Novartis Investigative Site Strasbourg
Germany Novartis Investigative Site Bochum
Germany Novartis Investigative Site Düsseldorf
Germany Novartis Investigative Site Essen
Germany Novartis Investigative Site Göttingen
Germany Novartis Investigative Site Koeln Nordrhein-Westfalen
Greece Novartis Investigative Site Athens
Greece Novartis Investigative Site Thessaloniki
Greece Novartis Investigative Site Thessaloniki
Israel Novartis Investigative Site Haifa
Israel Novartis Investigative Site Ramat Gan
Israel Novartis Investigative Site Tel Aviv
Italy Novartis Investigative Site Cefalù PA
Italy Novartis Investigative Site Ferrara
Italy Novartis Investigative Site Legnano MI
Italy Novartis Investigative Site Milano
Italy Novartis Investigative Site Pisa
Italy Novartis Investigative Site Rome
Italy Novartis Investigative Site Rozzano MI
Japan Novartis Investigative Site Aomori
Japan Novartis Investigative Site Bunkyo Tokyo
Japan Novartis Investigative Site Chiba
Japan Novartis Investigative Site Kodaira Tokyo
Japan Novartis Investigative Site Nagoya Aichi
Japan Novartis Investigative Site Sayama Osaka
Netherlands Novartis Investigative Site Amsterdam
Netherlands Novartis Investigative Site Maastricht
Poland Novartis Investigative Site Gdansk
Poland Novartis Investigative Site Katowice
Poland Novartis Investigative Site Lodz
Spain Novartis Investigative Site Barcelona Cataluña
Spain Novartis Investigative Site L´Hospitalet de Llobregat Cataluña
Spain Novartis Investigative Site Madrid
United Kingdom Novartis Investigative Site Glasgow
United Kingdom Novartis Investigative Site Headington Oxfordshire
United Kingdom Novartis Investigative Site Liverpool
United Kingdom Novartis Investigative Site London
United Kingdom Novartis Investigative Site Newcastle Upon Tyne
United States Novartis Investigative Site Boston Massachusetts
United States Novartis Investigative Site Burlington Vermont
United States Novartis Investigative Site Chicago Illinois
United States Novartis Investigative Site Columbus Ohio
United States Novartis Investigative Site Houston Texas
United States Novartis Investigative Site Louisville Kentucky
United States Novartis Investigative Site Miami Florida
United States Novartis Investigative Site New York New York
United States Novartis Investigative Site Orange California
United States Novartis Investigative Site Patchogue New York
United States Novartis Investigative Site Plainview New York
United States Novartis Investigative Site Saint Petersburg Florida

Sponsors (2)

Lead Sponsor Collaborator
Novartis Pharmaceuticals Mitsubishi Tanabe Pharma Corporation

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Czechia,  France,  Germany,  Greece,  Israel,  Italy,  Japan,  Netherlands,  Poland,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to First Confirmed Worsening on the Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Scale Confirmed worsening in CIDP was measured by the adjusted INCAT Disability Scale. The adjusted INCAT disability scale measures arm disability and leg disability. For arm disability the scale ranges from 0 (no upper limb problems) to 5 (inability to use either arm for any purposeful movement). The leg disability scale ranges from 0 (walking not affected) to 5 (restricted to wheelchair, unable to stand and walk a few steps with help). The total adjusted INCAT disability score is calculated by the sum of the arm and leg disability scores where the total score ranges from 0 to 10. A confirmed worsening was defined as an increase by 1 or more points on the adjusted INCAT disability scale from the value at baseline. Month 12
Secondary Change From Baseline for Grip Strength, Dominant Hand Grip strength measurements were done using a vigorimeter. With this device, the pressure in the bulb exercised by the participant was registered on a manometer via a rubber junction tube. Both the dominant and non-dominant hands were tested. A negative change from baseline indicates deterioration. baseline, Month 6, Month 12
Secondary Change From Baseline for Grip Strength, Non-dominant Hand Grip strength measurements were done using a vigorimeter. With this device, the pressure in the bulb exercised by the participant was registered on a manometer via a rubber junction tube. Both the dominant and non-dominant hands were tested. A negative change from baseline indicates deterioration. baseline, Month 6, Month 12
Secondary Change From Baseline for Rasch-Built Linearly Weighted Overall Disability Scale (R-ODS) This questionnaire was constructed using the patients' perception of their ability to perform daily and social activities. The 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). The obtained raw summed score was translated subsequently to a convenient centile metric score ranging from 0 (most severe disability) to 100 (no disability at all). A higher score indicated a better health status. A negative change from baseline indicates deterioration. baseline, Month 6, Month 12
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