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Dexamethason for the treatment of exacerbations in multiple sclerosis.


- candidate number2206
- NTR NumberNTR751
- ISRCTNISRCTN40435212
- Date ISRCTN created22-nov-2006
- date ISRCTN requested8-nov-2006
- Date Registered NTR14-aug-2006
- Secondary IDsN/A 
- Public TitleDexamethason for the treatment of exacerbations in multiple sclerosis.
- Scientific TitleDexamethason for the treatment of exacerbations in multiple sclerosis.
- ACRONYMdexamethason for relapse in MS
- hypothesisIn this double-blind randomized controlled trial, we would like to show that a five-day treatment course with 16mg/day oral dexamethason is effective in inducing recovery from an exacerbation of MS.
- Healt Condition(s) or Problem(s) studiedMultiple sclerosis (MS)
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2006
- planned closingdate1-sep-2007
- Target number of participants60
- InterventionsCapsule 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 patient who will take one capsule per day for five days.
- Primary outcomeThe 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 outcome1. 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 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.
- TimepointsN/A
- Trial web siteN/A
- statusstopped
- CONTACT FOR PUBLIC QUERIESdr. M.W. Koch
- CONTACT for SCIENTIFIC QUERIESdr. M.W. Koch
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
None
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD14-aug-2006 - 5-jan-2010


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