Dexamethason for the treatment of exacerbations in multiple sclerosis.
Suspended
- Conditions
- multiple sclerosis
- Registration Number
- NL-OMON22907
- Lead Sponsor
- niversity Medical Centre Groningen
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- 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;
Exclusion Criteria
1. Use of corticosteroids in the previous three months;
2. Contraindication for coritcosteroid-use (psychosis, active peptic ulcer, infection etc.);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1. The number of patients needing additional intravenous methylprednisolon-treatment;<br /><br>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;<br /><br>3. The number 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.<br />