Condition category
Nervous System Diseases
Date applied
22/11/2006
Date assigned
22/11/2006
Last edited
11/05/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr M W Koch

ORCID ID

Contact details

University Medical Centre Groningen (UCMG)
Department of Neurology
Hanzeplein 1
Groningen
9713 GZ
Netherlands
+31 (0)50 3616161
m.w.koch@neuro.umcg.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Ethics approval received from the local medical ethics committee

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

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

Phase

Not Specified

Drug names

Dexamethason

Primary outcome measures

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 trial start date

01/09/2006

Overall trial end date

01/09/2007

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

60

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

Trial participating centre

University Medical Centre Groningen (UCMG)
Groningen
9713 GZ
Netherlands

Sponsor information

Organisation

University Medical Center Groningen (UMCG) (The Netherlands)

Sponsor details

P.O. Box 30001
Groningen
9700 RB
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Not defined

Funder name

Not provided at time of registration

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes