Dexamethason for the treatment of exacerbations in multiple sclerosis

Phase 4

Withdrawn

Conditions: multiple sclerosis
10012303

Registration Number: NL-OMON30002

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 60

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The number of patients who describe an improvement in their clinical status of<br /><br>at least 5 points on a 10 point Likert scale (0=unchanged, 9=complete recovery<br /><br>to the pre-exacerbation level) on day six.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) The number of patients needing additional intravenous<br /><br>methylprednisolon-treatment<br /><br>2) The number of patients who describe an improvement of at least 5 points on a<br /><br>10-point-Likert scale on day 14 and 28.<br /><br>3) The numbe of patients with at least one point improvement on the Expanded<br /><br>Disability Status Scale (EDSS) on day 6, 14, 28 compared to the EDSS-score at<br /><br>randomisation</p><br>