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

NCT ID: NCT01625182

Last Updated: 2017-10-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-22

Study Completion Date

2016-09-03

Brief Summary

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

Detailed Description

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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.

Conditions

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Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Keywords

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chronic inflammatory demyelinating polyradiculoneuropathy, CIDP, FTY720, fingolimod.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Fingolimod (FTY720)

Participants received Fingolimod 0.5 mg orally once daily.

Group Type EXPERIMENTAL

Fingolimod

Intervention Type DRUG

Fingolimod 0.5 mg capsules

Placebo

Participants received matching placebo to Fingolimod orally once daily.

Group Type PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type DRUG

Matching placebo capsules

Interventions

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Fingolimod

Fingolimod 0.5 mg capsules

Intervention Type DRUG

Placebo Comparator

Matching placebo capsules

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* written informed consent must be obtained before any assessment is performed

Exclusion Criteria

* 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


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mitsubishi Tanabe Pharma Corporation

INDUSTRY

Sponsor Role collaborator

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Orange, California, United States

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Miami, Florida, United States

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St. Petersburg, Florida, United States

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Chicago, Illinois, United States

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Louisville, Kentucky, United States

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Boston, Massachusetts, United States

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New York, New York, United States

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Patchogue, New York, United States

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Plainview, New York, United States

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Columbus, Ohio, United States

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Houston, Texas, United States

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Burlington, Vermont, United States

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Sydney, New South Wales, Australia

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Auchenflower, Queensland, Australia

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Fitzroy, Victoria, Australia

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Parkville, Victoria, Australia

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Brussels, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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Kingston, Ontario, Canada

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Québec, Quebec, Canada

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Greenfield Park, , Canada

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Montreal, , Canada

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Prague, , Czechia

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Limoges, , France

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Marseille, , France

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Montpellier, , France

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Paris, , France

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Pessac, , France

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Strasbourg, , France

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Cologne, North Rhine-Westphalia, Germany

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Bochum, , Germany

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Düsseldorf, , Germany

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Essen, , Germany

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Göttingen, , Germany

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Athens, , Greece

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Thessaloniki, , Greece

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Thessaloniki, , Greece

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Haifa, , Israel

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Ramat Gan, , Israel

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Tel Aviv, , Israel

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Legnano, MI, Italy

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Rozzano, MI, Italy

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Cefalù, PA, Italy

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Ferrara, , Italy

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Milan, , Italy

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Pisa, , Italy

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Rome, , Italy

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Nagoya, Aichi-ken, Japan

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Aomori, Aomori, Japan

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Sayama, Osaka, Japan

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Bunkyo, Tokyo, Japan

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Kodaira, Tokyo, Japan

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Chiba, , Japan

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Amsterdam, , Netherlands

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Maastricht, , Netherlands

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Gdansk, , Poland

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Katowice, , Poland

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Lodz, , Poland

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Barcelona, Catalonia, Spain

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L'Hospitalet de Llobregat, Catalonia, Spain

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Madrid, , Spain

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Headington, Oxfordshire, United Kingdom

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Glasgow, , United Kingdom

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Liverpool, , United Kingdom

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London, , United Kingdom

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Newcastle upon Tyne, , United Kingdom

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Countries

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

References

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Hughes R, Dalakas MC, Merkies I, Latov N, Leger JM, Nobile-Orazio E, Sobue G, Genge A, Cornblath D, Merschhemke M, Ervin CM, Agoropoulou C, Hartung HP; FORCIDP Trial Investigators. Oral fingolimod for chronic inflammatory demyelinating polyradiculoneuropathy (FORCIDP Trial): a double-blind, multicentre, randomised controlled trial. Lancet Neurol. 2018 Aug;17(8):689-698. doi: 10.1016/S1474-4422(18)30202-3. Epub 2018 Jul 9.

Reference Type DERIVED
PMID: 30001923 (View on PubMed)

Other Identifiers

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2011-005280-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CFTY720I2201

Identifier Type: -

Identifier Source: org_study_id