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

University Medical Centre Groningen (UCMG)
Department of Neurology
Hanzeplein 1
Groningen
9713 GZ
Netherlands

Phone +31 (0)50 3616161
Email m.w.koch@neuro.umcg.nl

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleDexamethason for the treatment of exacerbations in multiple sclerosis
Study acronymdexamethason for relapse in MS
Study hypothesisIn 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
ConditionMultiple sclerosis (MS)
InterventionCapsule 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Dexamethason
Primary outcome measureThe 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 measures1. 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 date01/09/2006
Overall study end date01/09/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participants60
Participant inclusion criteria1. 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 criteria1. 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 date01/09/2006
Recruitment end date01/09/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

University Medical Centre Groningen (UCMG)
Groningen
9713 GZ
Netherlands

Sponsor information

University Medical Center Groningen (UMCG) (The Netherlands)
Hospital/treatment centre

P.O. Box 30001
Groningen
9700 RB
Netherlands

ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

23/09/2021: Proactive update review. No publications found. Search options exhausted.