Chronotherapy in Acute Multiple Sclerosis (MS) Attack

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

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.

Study Overview

• Status: Terminated
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: methylprednisolone; Drug: Sodium chlorid

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oppland
    • Lillehammer, Oppland, Norway, 2609
      • Innlandet Hosptal Trust-Lillehammer, Neurological Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Sykehuset Innlandet HF
• Investigators: Study Director: Anette H Farmen, Physician/MD, Innlandet Hospital Trust Lillehammer, Neurological Department; Study Director: Kristin I Løken-Amsrud, Physician/MD, Innlandet Hospital Trust Lillehammer, Neurological Department; Study Chair: Elisabeth G Celius, MD/PhD, Oslo University Hospital, Ullevål, Neurological department; Study Chair: Per O Vandvik, MD/PhD, Innlandet Hospital Trust Gjøvik, Department of Internal medicin; Study Chair: Trygve Holmøy, MD/PhD, Oslo University Hospital, Ullevål, Neurological department

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: October 1, 2008
• First Submitted That Met QC Criteria: October 1, 2008
• First Posted (Estimate): October 2, 2008

Study Record Updates

• Last Update Posted (Estimate): November 24, 2014
• Last Update Submitted That Met QC Criteria: November 21, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: methylprednisolone; EDSS; circadian rhythms; MSFC
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• Other Study ID Numbers: 15002 (Other Identifier: City of Hope Medical Center); 150134 (Innlandet Hospital Trust); 2008-002025-37 (EudraCT Number)