Condition category
Nervous System Diseases
Date applied
14/07/2005
Date assigned
07/09/2005
Last edited
24/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr IN van Schaik

ORCID ID

Contact details

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MEC02/007 PREDICT

Study information

Scientific title

Acronym

PREDICT-trial

Study hypothesis

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. Loss of reflexes is found in almost all patients, but may be confined to the ankles. The diagnosis of CIDP is based on the clinical, electrophysiological, cerebrospinal fluid features and, to a limited degree, on histopathology. Cerebrospinal fluid protein levels are generally elevated without cellular reaction.

Primary objective:
Induces pulsed high dose dexamethasone treatment remissions more often than standard prednisolone treatment in patients with CIDP?
Secondary objectives:
1. Induces pulsed high dose dexamethasone treatment remissions more rapidly than standard prednisolone treatment?
2. Is pulsed high dose dexamethasone treatment more effective than standard prednisolone treatment in improving disability and impairment?
3. Has pulsed high dose dexamethasone treatment less side effects than standard prednisolone treatment?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Chronic inflammatory demyelinating polyradiculoneuropathy

Intervention

1. Experimental treatment:
After randomisation a patient will start with 6 cycles of dexamethasone 40 mg per day orally for 4 consecutive days, repeated every 28 days. The cycles start in week 1, 5, 9, 13, 17, and 21. Simultaneously, patients will be treated with placebo according to the regimen described under alternative treatment.
2. Alternative treatment: After randomisation a patient will start with prednisolone 60 mg per day for 4 weeks. Subsequently, prednisolone will be tapered to alternate day dose and further decreased over time. Total treatment length will be 32 weeks. Simultaneously, patients will be treated with placebo according to the regimen described under Experimental treatment.
Patients in the experimental and alternative treatment group receive equivalent cumulative doses of corticosteroids during the study.

Intervention type

Drug

Phase

Not Specified

Drug names

Prednisolone and dexamethasone

Primary outcome measures

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

1. Time to reach remission
2. Proportion of patients with relapse at 12 months
3. Time to relapse
4. Proportion of patients with at least 3 points improvement on the Rivermead mobility index
5. Proportion of patients with at least 1 point improvement on the INCAT disability scale
6. Mean differences in grip strength as assessed with a handheld Vigorimeter in kg between dexamethasone and prednisolone treated group
7. Mean differences in MRC sum score between dexamethasone and prednisolone treated group
8. Changes in INCAT sensory sum score between dexamethasone and prednisolone treated group
9. Mean differences in SF-36 quality of life score between dexamethasone and prednisolone treated group
10. Electrophysiological parameters
11. Weight, blood pressure
12. Laboratory values
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)
14. Side effects

Overall trial start date

01/07/2002

Overall trial end date

01/01/2009

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

52

Participant 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

Recruitment start date

01/07/2002

Recruitment end date

01/01/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (The Netherlands)

Sponsor details

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor type

University/education

Website

http://www-amrweb/website/Home.htm

Funders

Funder type

Charity

Funder name

Prinses Beatrix Fonds (charity-trust); Trialnumber MAR01-0213.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Dept of Neurology, Academic Medical Center.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes