Multiple Sclerosis MedDRA version: 8.1 Level: PT Classification code 10028245 Term: Multiple sclerosis
Conditions
Interventions
Product Name: Dexamethason
Pharmaceutical Form: Capsule*
INN or Proposed INN: Dexamethasone
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Sponsors
Department of Neurology UMCG
Eligibility
Sex/Gender
All
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 18 - 65 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 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) no F.1.3.1 Number of subjects for this age range
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 |
|---|---|
| Main Objective: In this double-blind randomized controlled trial, we would like to show that treatment with a five day course of 16mg per day of oral dexamethason is effective for inducing recovery from an exacerbation in MS. ;Secondary Objective: ;Primary end point(s): 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. | — |
Countries
Netherlands
Outcome results
None listed