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
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