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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. |
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Register:
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EUCTR |
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Last refreshed on:
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7 January 2013 |
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Main ID: |
EUCTR2005-001136-76-IT |
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Date of registration:
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07/09/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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09/07/2007 |
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Target sample size:
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-001136-76 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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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
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Phase:
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Countries of recruitment
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Italy
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Contacts
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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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
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Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
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Intervention(s)
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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
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Primary Outcome(s)
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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.
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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.
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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).
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Secondary ID(s)
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KB034Emendamenton°2
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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