Randomiseret, dobbelt blindet placebokontrolleret undersøgelse af subkutan immunglobulinbehandling af kronisk inflammatorisk demyeliniserende polyradikuloneuropati (English: A randomized, double-blinded, placebo controlled trial of subcutaneous infusion of immunoglobulin in chronic inflammatory demyelinating polyradiculoneuropathy) - Subcutaneous Immunoglobulin in CIDP

Phase 1

• Conditions: Chronic inflammatory demyelinating polyradiculoneuropathy; MedDRA version: 12.0Level: LLTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathy

• Registration Number: EUCTR2009-013930-25-DK
• Lead Sponsor: Aarhus University Hospital, Department of Neurology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-09-25
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

All patients having typical or pure motor CIDP fulfilling European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) clinical and electrophysiological criteria for definite or probable CIDP and in regular treatment with IVIG at neurological departments in Denmark
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Age below 18 and above 80 years at time of inclusion.
Pregnancy.
Increased coagulation time (INR > 1.5, thrombocyte count < 100 milion/ml))
Malignancies.
Other causes of neuropathy (diabetes melitus, MGUS)
Severe medical diseases
Other immunomodulating treatment than IVIG within the last 6 weeks.
Hepatitis B or C or HIV
Lactation.
Non-responsiveness to IVIG treatment.
Allergy to immunglobulin

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to assess efficacy, feasibility and safety of frequent small doses of immunoglobulin administered subcutaneously compared to subcutaneous administration of placebo in CIDP patients.;Secondary Objective: to assess efficacy of immunoglobulin administered subcutaneously compared to intravenous immunoglobulin (IVIG) ;Primary end point(s): The change in dynamometric muscle strength, measured by the Biodex System 3® dynamometer, of four pre-selected muscle groups from baseline until last evaluation in the active treatment group versus placebo.