Chronotherapy in Acute Multiple Sclerosis (MS) Attack
Treatment With Methylprednisolone in Acute Exacerbations of Multiple Sclerosis: Enhanced Effect With Nighttime Treatment?
What it found
The trial ended early for another reason (see below).
Reason given: Low inclusion frequency and not enough human resources for completing study
This trial finished 14 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Methylprednisolone
Glucocorticoid receptor agonist
- Sodium chlorid
What it measured
Main measures
The difference in mean changes in EDSS-score between the group receiving treatment during the night opposed to during the day.
At admittion, directly after treatment, ca 30 days after treatment
Disability progression
Other measures (6)
The difference in MSFC-score in the two groups
At admittion, directly after treatment, ca 30 days after treatment
Disability progressionSide effect registered by the patient
At admittion (baseline), during treatment, directly after treatment
SafetyThe patient's quality of life
At admittion, directly after treatment, 7 days and ca 30 days after treatment
Quality of life (reported by participants)MRI - volume and number for MS-lesions, Gd-enhancement
At admission, directly after treatment and ca 30 days after treatment
MRI lesionsFatigue
Before, after and ca 30 days after treatment
FatigueDepression
Before, after and ca 30 days after treatment
Mood and sleep
Who could take part
Relapsing MS · 18 and over
Show the full criteria
Inclusion criteria
* Relapsing remitting MS * EDSS-score before the actual attack \< 6.0 * Acute MS-attack with indication for treatment with steroids * Symptoms >24 hours \< 4 weeks * Age 18 years or older
Exclusion criteria
* Prior enrollment in this study * Ongoing serious infection that is a contraindication for treatment with steroids * Pregnancy * Medical situations (prior acute diseases) where treatment with intravenous steroids over short period of time is contraindicated or not favorable. * Enhanced cognitive dysfunction * Treatment with p.o or i.v steroids within 3 weeks prior to date of inclusion
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The Immunological system is showing a diurnal rhythmicity. The Mediators that enhances inflammation are at highest level during the night. At the same time the endogenous production of cortisol is at its lowest. We want to study if there is a better effect of treatment with Methylprednisolone for acute MS-attacks if given at nighttime. The effect will be measured in relation to neurological deficits and function with Kurtzkes Expanded Disability Status Score (EDSS) and Multiple Sclerosis Functional Composite (MSFC). We want to see if the mean improvement in EDSS is greater in the group receiving treatment at night opposed to the group that get treatment during the daytime.
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History
Started
Apr 2009
Main results due
Jul 2012
Finished
Jul 2012