A Randomized controlled trial comparing two different immunoglobulins in the treatment of CIDP.
Phase 3
Completed
- Conditions
- peripheral nerve lesionpolyneuropathy1000381610034606
- Registration Number
- NL-OMON31412
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 25
Inclusion Criteria
minimum age of 18 years, improvement of muscle function after start Gammagard, active illness, ongoing intermittent treatment with a stable Gammagard dose. clinical and EMG findings compatible with CIDP
Exclusion Criteria
IgA deficiency or allergic reactions to IVIg. Hereditary neuropathy or severe concomittant illness. MMN. atypical CIDP.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The efficacy: the ODSS will be used as the primary outcomescale. A change of<br /><br>more than one point on the ODSS from baseline will be considered as improvement<br /><br>or worsening. A change of mean ODSS between the two groups of 1 point or less<br /><br>will be seen as equivalence. The vigorimeter and the MRC sumscore will be used<br /><br>as secondary outcome measurements. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary objective will be to record the occurence of side-effects and the<br /><br>preferences of patients regarding the medication. </p><br>