Prednisolone versus dexamethasone in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) trial

Completed

Conditions: Chronic inflammatory demyelinating polyradiculoneuropathy
Nervous System Diseases
Inflammatory polyneuropathy

Registration Number: ISRCTN07779236

Lead Sponsor: Academic Medical Centre (AMC) (The Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

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.

Exclusion Criteria

1. Abnormal erythrocyte sedimentation rate, hemoglobulin, white cell count, immuno-electrophoresis or immunofixation (with the exception of an IgG MGUS), TSH, Vitamin B1/B12, gamma-GT, or glucose
2. Pleocytosis in cerebrospinal fluid (CSF) of more than 90/3 (30/mm^3)
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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure has been defined as the proportion of patients in remission at 12 months after start of first treatment. A remission is defined as improvement of at least 3 points on the Rivermead mobility index ánd an improvement of at least 1 point on the INCAT disability scale as compared with baseline. Each relapse during the follow-up period will be considered a treatment failure and excludes the possibility of a remission at 12 months.

Secondary Outcome Measures

Name	Time	Method
1. Time to reach remission<br>2. Proportion of patients with relapse at 12 months<br>3. Time to relapse<br>4. Proportion of patients with at least 3 points improvement on the Rivermead mobility index<br>5. Proportion of patients with at least 1 point improvement on the INCAT disability scale<br>6. Mean differences in grip strength as assessed with a handheld Vigorimeter in kg between dexamethasone and prednisolone treated group<br>7. Mean differences in MRC sum score between dexamethasone and prednisolone treated group<br>8. Changes in INCAT sensory sum score between dexamethasone and prednisolone treated group<br>9. Mean differences in SF-36 quality of life score between dexamethasone and prednisolone treated group<br>10. Electrophysiological parameters<br>11. Weight, blood pressure<br>12. Laboratory values<br>13. Bone densitometry of the lower spinal vertebra and a visit to an ophthalmologist to exclude glaucoma and cataract (within first 4 weeks after inclusion)<br>14. Side effects