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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01625182
• Date of registration: 19/06/2012
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Evaluate Efficacy and Safety of Fingolimod 0.5 mg Orally Once Daily Versus Placebo in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients.
• Scientific 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)
• Date of first enrolment: December 22, 2012
• Target sample size: 106
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01625182
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Intervention(s)

Drug: Fingolimod

Drug: Placebo Comparator

Primary Outcome(s)

Time to First Confirmed Worsening on the Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Scale [Time Frame: Month 12]

Secondary Outcome(s)

Change From Baseline for Grip Strength, Dominant Hand [Time Frame: baseline, Month 6, Month 12]

Change From Baseline for Grip Strength, Non-dominant Hand [Time Frame: baseline, Month 6, Month 12]

Change From Baseline for Rasch-Built Linearly Weighted Overall Disability Scale (R-ODS) [Time Frame: baseline, Month 6, Month 12]

Secondary ID(s)

CFTY720I2201

2011-005280-24

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Mitsubishi Tanabe Pharma Corporation

Results

• Results available: Yes
• Date Posted: 19/09/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01625182