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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 26 September 2016
Main ID:  EUCTR2011-005280-24-NL
Date of registration: 19/07/2012
Prospective Registration: Yes
Primary sponsor: Novartis Pharma Services AG
Public title: Evaluate efficacy and safety of fingolimod 0.5 mg orally once daily versus placebo in chronic inflammatory demyelinating polyradiculoneuropathy
Scientific title: A double-blind, randomized, multicenter, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
Date of first enrolment: 30/01/2013
Target sample size: 156
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-005280-24
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Australia Belgium Canada Czech Republic France Germany Greece Israel
Italy Japan Netherlands Norway Poland Spain United Kingdom United States
Contacts
Name: AD Project Management CNS   
Address:  Vaillant Couturier 94853 Ivry-Sur-Seine Cedex France
Telephone: +33467402887
Email: kim.dawe@ppdi.com
Affiliation:  PPD
Name: AD Project Management CNS   
Address:  Vaillant Couturier 94853 Ivry-Sur-Seine Cedex France
Telephone: +33467402887
Email: kim.dawe@ppdi.com
Affiliation:  PPD
Key inclusion & exclusion criteria
Inclusion criteria:
Inclusion Criteria
1. written informed consent must be obtained before any assessment is
performed
2. 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. (Van den Bergh et
al 2010 and Erratum 2011)
3. 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
4. receiving IVIg treatment (minimal
dose equivalent to 0.4 g/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
5. History of documented clinically meaningful deterioration confirmed by clinical examination, during therapy or upon interruption or reduction of therapies within 18 months prior to Screening
6. Stable CIPD symptoms without significant change in treatment regimen for the 6 weeks before randomization.
6. Male or female, aged 18 years or older at Screening
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 78
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 78

Exclusion criteria:
Exclusion Criteria
1. other chronic demyelinating neuropathies, including: • Distal Acquired Demyelinating Symmetric Neuropathy (DADS) • Multifocal Motor Neuropathy with conduction block (MMN) • pure sensory CIDP • hematopoietic malignancy except for MGUS IgG or IgA
2. conditions in which the pathogenesis of the neuropathy may be different from CIDP such as: Lyme disease, POEMS syndrome, osteosclerotic myeloma, Castleman’s
disease
3. treatment with: • plasma exchange within 2 months of randomization
•immunosuppressive/chemotherapeutic medications:
• azathioprine, cyclophosphamide, cyclosporine, mycophenolate, etanercept, methotrexate, tacrolimos 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 prior to randomization should have B-cell (CD19/CD20) testing performed and if values are within normal range, patients are eligible to participate.
• other cytotoxic immunosuppressive medications with sustained effects (including mitoxantrone, alemtuzumab, cladribine) at any time • hematopoietic stem cell transplantation at any time
4. a CIDP relapse or significant worsening of symptoms within 2 months of randomization.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 18.0 Level: PT Classification code 10057645 Term: Chronic inflammatory demyelinating polyradiculoneuropathy System Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intervention(s)

Product Name: fingolimod
Product Code: FTY720I
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: fingolimod
CAS Number: 162359-56-0
Current Sponsor code: FTY720
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)
Main Objective: To evaluate the effect of fingolimod 0.5 mg daily compared with placebo on delaying disability progression, in patients with CIDP, measured by the time to the first confirmed worsening on the adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Scale. A confirmed worsening is defined as an increase by 1 point or more on the adjusted INCAT Disability Scale from the value at Baseline.
Primary end point(s): Delay of disease progression, measured by time to first confirmed worsening on the adjusted INCAT disability scale by 1 point or more from the value at baseline, in patients who were being treated with IVIG and/or corticosteroids prior to study start.
Secondary Objective: • to assess the change in grip strength from Baseline to Month 6/End-of-Treatment (whichever occurs first) in CIDP patients on fingolimod as compared with those on placebo
• to assess the change in Rasch-Built Linearly Weighted Overall Disability Scale (R-ODS) from Baseline to Month 6/End-of-Treatment (whichever occurs first) in CIDP patients on fingolimod as compared with those on placebo
• to evaluate safety and tolerability of fingolimod compared with placebo in patients with CIDP
Timepoint(s) of evaluation of this end point: time to event
Secondary Outcome(s)
Secondary end point(s): 1) The change in grip strength from baseline in CIDP patients on fingolimod as compared with those on placebo. Grip strength measurements will be done using a vigorimeter
2) The 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
3) Safety and tolerability of fingolimod compared with placebo in patients with CIDP. Measured by AE/SAE, hematology and biochemistry lab tests, vital signs, ECG, and pulmonary function test.
Timepoint(s) of evaluation of this end point: 1) Month 6/ End of treatment
2) Month 6/ End of treatment
3) End of study
Secondary ID(s)
2011-005280-24-BE
CFTY720I2201
NCT01625182
Source(s) of Monetary Support
Novartis Pharma Services AG
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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