multiple sclerosis
Conditions
Interventions
Capsule containing 16mg of dexamethason and identical placebo capsules will be
prepared by the pharmacy of the Groningen University Medical Centre. The
Medication (5 capsules) will be given to the p
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) patients with multiple sclerosis (MS), diagnosed according to the MacDonald criteria with a relapsing-remitting or secundary progressieve subtype. 2) age older than 18 yrs, male or female 3) patients have to be experiencing an exacrebation. Exacerbation is defined as the development of a new symptom or the worsening of an established symptoms of MS of a duration of more than 24 hours and in the absence of fever or other disease 4) The exacerbation must encompass at least one of the following symptoms: arm or leg paresis, gait problems because of paresis or ataxia, limb ataxia, sensory loss, optic neurtitis, diplopia 5) The exacerbation is present for no more than seven days at randomisation 6) Informed consent
Exclusion criteria
Exclusion criteria: 1) Use of corticosteroids in the previous three months 2) Contraindication for coritcosteroid-use (psychosis, active peptic ulcer, infection etc.) 3) Circumstanced in which constant medical monitoring is required ( e.g. diabetes mellitus) 4) Pregancy and breast-feeding 5) A MS-relapse in the previous eight weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of patients who describe an improvement in their clinical status of at least 5 points on a 10 point Likert scale (0=unchanged, 9=complete recovery to the pre-exacerbation level) on day six. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) The number of patients needing additional intravenous methylprednisolon-treatment 2) The number of patients who describe an improvement of at least 5 points on a 10-point-Likert scale on day 14 and 28. 3) The numbe of patients with at least one point improvement on the Expanded Disability Status Scale (EDSS) on day 6, 14, 28 compared to the EDSS-score at randomisation | — |
Countries
Netherlands
Outcome results
None listed