Evaluate Efficacy and Safety of Fingolimod 0.5 mg Orally Once Daily Versus Placebo in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients.
Status: | Completed |
---|---|
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 11/1/2017 |
Start Date: | December 22, 2012 |
End Date: | September 3, 2016 |
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)
The study was designed to evaluate the efficacy and safety of fingolimod in the treatment of
chronic inflammatory demyelinating polyradiculoneuropathy compared with placebo.
chronic inflammatory demyelinating polyradiculoneuropathy compared with placebo.
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.
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.
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
We found this trial at
13
sites
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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