In 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.
ID
Bron
Verkorte titel
Aandoening
multiple sclerosis
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
In 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.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
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 patient who will take one capsule per day for five days.
Algemeen / deelnemers
Department of Neurology
Hanzeplein 1
M.W. Koch
Groningen 9713 GZ
The Netherlands
+31(0)50 3616161
m.w.koch@neuro.umcg.nl
Wetenschappers
Department of Neurology
Hanzeplein 1
M.W. Koch
Groningen 9713 GZ
The Netherlands
+31(0)50 3616161
m.w.koch@neuro.umcg.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL741 |
| NTR-old | NTR751 |
| Ander register | : N/A |
| ISRCTN | ISRCTN40435212 |