World Health Organization site
Skip Navigation Links

Main
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: 3 October 2016
Main ID:  EUCTR2011-005280-24-ES
Date of registration: 07/08/2012
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: 19/09/2012
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: Project Manager   
Address:  45-47 Blvd Paul Vaillant Couturier 94853 Ivry-Sur-Seine Cedex France
Telephone: +33467402887
Email: kim.dawe@ppdi.com
Affiliation:  PPD
Name: Project Manager   
Address:  45-47 Blvd Paul 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. Either confirmed diagnosis of typical CIDP as defined by the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) Task Force First Revision Or one of the following forms of atypical CIDP: - pure motor CIDP - MADSAM
(Lewis-Sumner syndrome) - CIDP in association with MGUS IgG or IgA but not IgM MGUS
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/kg every 4 weeks) or corticosteroids (minimal dose equivalent to prednisone 10 mg/day) treatment prior to the screening visit
5. history of relapsing or progressive clinical course upon interruption or reduction of therapies within 1 year prior to Screening
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 within 6 months of randomization -
Rituximab in the 2 years prior to randomization - other immunosuppressive medications (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: 14.1 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)

Trade Name: GILENYA 0,5 mg cápsulas duras
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: HIDROCLORURO DE FINGOLIMOD
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
Source(s) of Monetary Support
Novartis Pharma Services AG
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history