Chronotherapy in Acute Multiple Sclerosis (MS) Attack

Study Overview
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Brief Summary
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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.

Official Title
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Treatment With Methylprednisolone in Acute Exacerbations of Multiple Sclerosis: Enhanced Effect With Nighttime Treatment?

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: methylprednisolone
* Drug: Sodium chlorid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Both study arms receive both active treatment = methylprednisolone and an inactive treatment = Sodium chlorid (dummy) | Drug: methylprednisolone<br>* 1 gram intravenous a day for 3 days<br>* Other names: Solu-Medrol. ACT-nr:H02A B04;Drug: Sodium chlorid<br>* Sodium chlorid 9mg/ml 500 ml per day in 3 days<br>* Other names: ATC: B05B B01;|
| Active Comparator: 2<br>Both arms receives both active treatment and inactive treatment = dummy. Active treatment is methylprednisolone, inactive treatment is sodium chlorid. | Drug: methylprednisolone<br>* 1 gram intravenous a day for 3 days<br>* Other names: Solu-Medrol. ACT-nr:H02A B04;Drug: Sodium chlorid<br>* Sodium chlorid 9mg/ml 500 ml per day in 3 days<br>* Other names: ATC: B05B B01;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in MSFC-score in the two groups |  | At admittion, directly after treatment, ca 30 days after treatment | 
| 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 | 
| MRI - volume and number for MS-lesions, Gd-enhancement |  | At admission, directly after treatment and ca 30 days after treatment | 
| Fatigue |  | Before, after and ca 30 days after treatment | 
| Depression |  | Before, after and ca 30 days after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EDSS, methylprednisolone, circadian rhythms, MSFC