A randomised controlled trial comparing two different immunoglobulins in the treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Completed

• Conditions: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP); Nervous System Diseases; Polyneuropathies

• Registration Number: ISRCTN52121370
• Lead Sponsor: Erasmus Medical Centre (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-16
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

1. Minimum age 18 years
2. Improvement of muscle function after start Gammagard
3. Active illness
4. Ongoing intermittent treatment with a stable Gammagard dose
5. Clinical and Electromyography (EMG) findings compatible with CIDP

Exclusion Criteria

1. Immunoglobulin A (IgA) deficiency or allergic reactions to Intravenous Immunoglobulin (IVIg)
2. Hereditary neuropathy or severe concomitant illness
3. Multifocal Motor neuropathy (MMn), atypical CIDP

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Efficacy: the Overall Disability Sum Score (ODSS) will be used as the primary outcome scale. A change of more than one point will be considered as improvement or worsening<br>2. The vigorimeter and Medical Research Council (MRC) sum score will be used as secondary outcome scales

Secondary Outcome Measures

Name	Time	Method
1. The occurrence of side-effects<br>2. The preferences of patients regarding the medication