Chronotherapy in Acute Multiple Sclerosis (MS) Attack

Not Applicable

Terminated

• Conditions: Multiple Sclerosis
• Interventions: Drug: methylprednisolone; Drug: Sodium chlorid

• Registration Number: NCT00764413
• Lead Sponsor: Sykehuset Innlandet HF

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-10-01
• Study First Submitted QC: 2008-10-01
• Study First Posted: 2008-10-02
• Study Start: 2009-04
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2014-02
• Last Update Submitted: 2014-11-21
• Last Update Posted: 2014-11-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 57

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Sodium chlorid	Both arms receives both active treatment and inactive treatment = dummy. Active treatment is methylprednisolone, inactive treatment is sodium chlorid.
1	Sodium chlorid	Both study arms receive both active treatment = methylprednisolone and an inactive treatment = Sodium chlorid (dummy)
1	methylprednisolone	Both study arms receive both active treatment = methylprednisolone and an inactive treatment = Sodium chlorid (dummy)
2	methylprednisolone	Both arms receives both active treatment and inactive treatment = dummy. Active treatment is methylprednisolone, inactive treatment is sodium chlorid.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Depression	Before, after 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
The difference in MSFC-score in the two groups	At admittion, directly after treatment, ca 30 days after treatment
Fatigue	Before, after and ca 30 days after treatment

Trial Locations

Locations (1)

Innlandet Hosptal Trust-Lillehammer, Neurological Department; 🇳🇴 Lillehammer, Oppland, Norway