Dexamethason for the treatment of exacerbations in multiple sclerosis
| ISRCTN | ISRCTN40435212 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40435212 |
| Protocol serial number | NL741 (NTR751) |
| Sponsor | University Medical Center Groningen (UMCG) (The Netherlands) |
| Funder | Not provided at time of registration |
- Submission date
- 22/11/2006
- Registration date
- 22/11/2006
- Last edited
- 23/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
University Medical Centre Groningen (UCMG)
Department of Neurology
Hanzeplein 1
Groningen
9713 GZ
Netherlands
| Phone | +31 (0)50 3616161 |
|---|---|
| m.w.koch@neuro.umcg.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Dexamethason for the treatment of exacerbations in multiple sclerosis |
| Study acronym | dexamethason for relapse in MS |
| Study objectives | In this double-blind randomised controlled trial, we would like to show that a five-day treatment course with 16 mg/day oral dexamethason is effective in inducing recovery from an exacerbation of Multiple Sclerosis (MS). |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Multiple sclerosis (MS) |
| Intervention | Capsule containing 16 mg of dexamethason and identical placebo capsules will be prepared by the pharmacy of the Groningen University Medical Centre. The Medication (five capsules) will be given to the patient who will take one capsule per day for five days. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Dexamethason |
| Primary outcome measure(s) |
The number of patients who describe an improvement in their clinical status of at least five points on a ten point Likert scale (zero = unchanged, nine = complete recovery to the pre-exacerbation level) on day six. |
| Key secondary outcome measure(s) |
1. The number of patients needing additional intravenous methylprednisolon-treatment. |
| Completion date | 01/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 60 |
| Key inclusion criteria | 1. Patients with MS, diagnosed according to the MacDonald criteria with a relapsing-remitting or secondary progressive subtype 2. Age older than 18 years, 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 symptom 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: a. arm or leg paresis b. gait problems because of paresis or ataxia c. limb ataxia d. sensory loss e. optic neurtitis f. diplopia 5. The exacerbation is present for no more than seven days at randomisation 6. Informed consent |
| Key exclusion criteria | 1. Use of corticosteroids in the previous three months 2. Contraindication for corticosteroid use (psychosis, active peptic ulcer, infection etc.) 3. Circumstanced in which constant medical monitoring is required (e.g. diabetes mellitus) 4. Pregnancy and breast-feeding 5. A MS-relapse in the previous eight weeks |
| Date of first enrolment | 01/09/2006 |
| Date of final enrolment | 01/09/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
9713 GZ
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
23/09/2021: Proactive update review. No publications found. Search options exhausted.
