Dexamethason for the treatment of exacerbations in multiple sclerosis
| ISRCTN | ISRCTN40435212 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40435212 |
| Secondary identifying numbers | NL741 (NTR751) |
- 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Dr M W Koch
Scientific
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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Dexamethason for the treatment of exacerbations in multiple sclerosis |
| Study acronym | dexamethason for relapse in MS |
| Study hypothesis | 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 |
| Condition | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Dexamethason |
| Primary outcome measure | 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. |
| Secondary outcome measures | 1. The number of patients needing additional intravenous methylprednisolon-treatment. 2. The number of patients who describe an improvement of at least five points on a ten-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 six, 14, 28 compared to the EDSS-score at randomisation. |
| Overall study start date | 01/09/2006 |
| Overall study end date | 01/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 60 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/09/2006 |
| Recruitment end date | 01/09/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Centre Groningen (UCMG)
Groningen
9713 GZ
Netherlands
9713 GZ
Netherlands
Sponsor information
University Medical Center Groningen (UMCG) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
P.O. Box 30001
Groningen
9700 RB
Netherlands
"ROR" |
https://ror.org/03cv38k47 |
|---|
Funders
Funder type
Not defined
Not provided at time of registration
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
23/09/2021: Proactive update review. No publications found. Search options exhausted.
