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Chronotherapy in Acute Multiple Sclerosis (MS) Attack

NCT00764413 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2014-11-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

methylprednisolone

1 gram intravenous a day for 3 days

DRUG

Sodium chlorid

Sodium chlorid 9mg/ml 500 ml per day in 3 days

Sponsors & Collaborators

  • Sykehuset Innlandet HF

    lead OTHER

Principal Investigators

  • Anette H Farmen, Physician/MD · Innlandet Hospital Trust Lillehammer, Neurological Department

  • Kristin I Løken-Amsrud, Physician/MD · Innlandet Hospital Trust Lillehammer, Neurological Department

  • Elisabeth G Celius, MD/PhD · Oslo University Hospital, Ullevål, Neurological Department

  • Per O Vandvik, MD/PhD · Innlandet Hospital Trust Gjøvik, Department of Internal medicin

  • Trygve Holmøy, MD/PhD · Oslo University Hospital, Ullevål, Neurological department

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • Norway

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00764413 on ClinicalTrials.gov