Multiple Sclerosis
Conditions
Keywords
EDSS, methylprednisolone, circadian rhythms, MSFC
Brief summary
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.
Interventions
DRUGmethylprednisolone
1 gram intravenous a day for 3 days
DRUGSodium chlorid
Sodium chlorid 9mg/ml 500 ml per day in 3 days
Sponsors
Sykehuset Innlandet HF
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Side effect registered by the patient | At admittion (baseline), during treatment, directly after treatment |
| The patient's quality of life | At admittion, directly after treatment, 7 days and ca 30 days after treatment |
| The difference in MSFC-score in the two groups | At admittion, directly after treatment, ca 30 days after treatment |
| Fatigue | Before, after and ca 30 days after treatment |
| Depression | Before, after and ca 30 days after treatment |
| MRI - volume and number for MS-lesions, Gd-enhancement | At admission, directly after treatment and ca 30 days after treatment |
Countries
Norway
Outcome results
None listed