Prednisolone versus Dexamethasone in Chronic inflammatory demyelinating polyradiculoneuropathy Trial; PREDICT-trial - PREDICT trial

Conditions: Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is an immune-mediated disorder. CIDP is characterised by motor and/or sensory symptoms and signs in more than one limb, developing over at least two months. The disease runs a progressive, relapsing-remitting or monophasic course. The diagnosis of CIDP is based on the clinical, electrophysiological, cerebrospinal fluid features and, to a limited degree, on histopathology.

Registration Number: EUCTR2004-002783-24-GB

Lead Sponsor: AMC Medical research BV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 52

Inclusion Criteria

Eligible patients have to have signs and symptoms consistent with CIDP according to the diagnostic criteria as defined by a Dutch Consensus group in 1997. These criteria are derived from the much used and cited criteria of the ad hoc subcommittee of the American Academy of Neurology AIDS Task Force 1991 but contain a few practical modifications. Only definite or probable CIDP patients will be included.
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

1. Abnormal erythrocyte sedimentation rate, hemoglobuline, white cell count, immuno-electrophoresis or immunofixation (with the exception of a IgG MGUS), TSH, Vitamin B1/B12, gamma-GT, or glucose
2. Pleocytosis in cerebrospinal fluid (CSF) of more than 90/3 (30/mm3)
3. Received treatment for CIDP before
4. Use of drugs which are known to cause neuropathy
5. Age under 18 years
6. Contraindication for corticosteroid treatment
7. Pregnancy or active wish to become pregnant
8. Diseases known to cause neuropathy or to reduce mobility
9. Diseases known to lead to severe handicap or death at short notice
10. Patients with a subacute inflammatory demyelinating polyneuropathy (SIDP); this is a subset of patients with spontaneous recovery within 3 months and a monophasic course
11. Pure motor CIDP: no sensory signs or symptoms and no abnormalities in sensory nerve conduction studies (SNAP, SNCV, SDLT)
12. Refusal to give informed consent or withdrawal of previously given permission