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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: 7 January 2013
Main ID:  EUCTR2005-001136-76-IT
Date of registration: 07/09/2007
Prospective Registration: Yes
Primary sponsor: KEDRION
Public title: Double blind Randomized Controlled trial of prolonged treatment of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)with high dose intravenous immunoglobulins (IVIg) or intravenous metilprednisolone (IVMP). A phase III study. - IVIg CIDP
Scientific title: Double blind Randomized Controlled trial of prolonged treatment of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)with high dose intravenous immunoglobulins (IVIg) or intravenous metilprednisolone (IVMP). A phase III study. - IVIg CIDP
Date of first enrolment: 09/07/2007
Target sample size:
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-001136-76
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: yes Placebo: no Other: no Number of treatment arms in the trial: 2  
Phase: 
Countries of recruitment
Italy
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
1. Typical CIDP in accordance with: 'European Federation of Neurological Societies/Peripheral Nerve Society' guidelines on management of chronic inflammatory demyelinating polyradoculoneuropathy. Report of a joint task force of the European Federation of Neurological Societies and the Peripheral Nerve Society' (Journal of Peripheral Nervous System, 2005; 10(3):220-228). 2. Active or stationary phase of the disorder with non spontaneous improvement. 3 . > 18 years old and signed the Informed Consent Form 4. Significant disability in INCAT scale to the upper (2 or more) limbs or inferior limbs (1 or more) or to Rankin scale(2 or more).
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Atypical CIDP (EFNS/PNS)


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: IGVENA*FL 200ML 10G+SET
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Immunoglobulins, normal human, for intravascular adm.
Concentration unit: % percent
Concentration number: .5-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)
Main Objective: The primary study objective is to determine if IVIg treatment is better tolerate and/or more efficacious versus high doses intravenous metilprednisolone (MPIV) in CIDP induction (15 days) and long term improvement maintenance (6 months). This objective will be evaluated comparing the percentage of patients suspending IVIg and of patients suspending MPIV during the 6 months of treatment after undesiderable effects or treatment inefficacy (lack of response or worsening).
Primary end point(s): Difference in the percentage of patients suspending one of the therapies during 6 months of treatment after undesiderable effects or treatment inefficacy (lack of response or worsening) or both.
Secondary Objective: The second objective is to evaluate if IVIg treatment is more efficacious versus high doses intravenous metilprednisolone (IVMP)in relapse preventing after 6 months suspension of therapy.
Secondary Outcome(s)
Secondary ID(s)
KB034Emendamenton┬░2
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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