Chronotherapy in Acute Multiple Sclerosis (MS) Attack

• The difference in MSFC-score in the two groups [ Time Frame: At admittion, directly after treatment, ca 30 days after treatment ] [ Designated as safety issue: No ]
• Side effect registered by the patient [ Time Frame: At admittion (baseline), during treatment, directly after treatment ] [ Designated as safety issue: No ]
• The patient`s quality of life [ Time Frame: At admittion, directly after treatment, 7 days and ca 30 days after treatment ] [ Designated as safety issue: No ]
• MRI - volume and number for MS-lesions, Gd-enhancement [ Time Frame: At admission, directly after treatment and ca 30 days after treatment ] [ Designated as safety issue: No ]
• Fatigue [ Time Frame: Before, after and ca 30 days after treatment ] [ Designated as safety issue: No ]
• Depression [ Time Frame: Before, after and ca 30 days after treatment ] [ Designated as safety issue: No ]

• The difference in MSFC-score in the two groups [ Time Frame: At admittion, 7-10 days after treatment, ca 30 days after treatment ] [ Designated as safety issue: No ]
• Side effect registered by the patient [ Time Frame: At admittion (baseline), during treatment, 7-10 days after treatment og ca 30 days after treatment. ] [ Designated as safety issue: No ]
• The patient`s quality of life [ Time Frame: At admittion, before discharge, 7-10 days and ca 30 days after treatment ] [ Designated as safety issue: No ]

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. 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.

• Drug: methylprednisolone
  1 gram intravenous a day for 3 days
  Other Name: Solu-Medrol. ACT-nr:H02A B04
• Drug: Sodium chlorid
  Sodium chlorid 9mg/ml 500 ml per day in 3 days
  Other Name: ATC: B05B B01

• Active Comparator: 1
  Both study arms receive both active treatment = methylprednisolone and an inactive treatment = Sodium chlorid (dummy)
  Interventions:

  • Drug: methylprednisolone
  • Drug: Sodium chlorid
• Active Comparator: 2
  Both arms receives both active treatment and inactive treatment = dummy. Active treatment is methylprednisolone, inactive treatment is sodium chlorid.
  Interventions:

  • Drug: methylprednisolone
  • Drug: Sodium chlorid

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