Clinical trial NCT00764413: Chronotherapy in Acute Multiple Sclerosis (MS) Attack
Official title: Treatment With Methylprednisolone in Acute Exacerbations of Multiple Sclerosis: Enhanced Effect With Nighttime Treatment?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: EDSS
methylprednisolone
circadian rhythms
MSFC
Lead sponsor: Sykehuset Innlandet HF
Sponsor class: OTHER
First posted: 2008-10-02
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: The difference in mean changes in EDSS-score between the group receiving treatment during the night opposed to during the day.
timeFrame: At admittion, directly after treatment, ca 30 days after treatment
Secondary outcomes:
measure: The difference in MSFC-score in the two groups
timeFrame: At admittion, directly after treatment, ca 30 days after treatment
measure: Side effect registered by the patient
timeFrame: At admittion (baseline), during treatment, directly after treatment
measure: The patient's quality of life
timeFrame: At admittion, directly after treatment, 7 days and ca 30 days after treatment
measure: MRI - volume and number for MS-lesions, Gd-enhancement
timeFrame: At admission, directly after treatment and ca 30 days after treatment
measure: Fatigue
timeFrame: Before, after and ca 30 days after treatment
measure: Depression
timeFrame: Before, after and ca 30 days after treatment
Other outcomes:
Locations:
city: Lillehammer
country: Norway
facility: Innlandet Hosptal Trust-Lillehammer, Neurological Department
state: Oppland
Study officials:
affiliation: Innlandet Hospital Trust Lillehammer, Neurological Department
name: Anette H Farmen, Physician/MD
role: STUDY_DIRECTOR
affiliation: Innlandet Hospital Trust Lillehammer, Neurological Department
name: Kristin I Løken-Amsrud, Physician/MD
role: STUDY_DIRECTOR
affiliation: Oslo University Hospital, Ullevål, Neurological Department
name: Elisabeth G Celius, MD/PhD
role: STUDY_CHAIR
affiliation: Innlandet Hospital Trust Gjøvik, Department of Internal medicin
name: Per O Vandvik, MD/PhD
role: STUDY_CHAIR
affiliation: Oslo University Hospital, Ullevål, Neurological department
name: Trygve Holmøy, MD/PhD
role: STUDY_CHAIR
References: