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Chronotherapy in Acute Multiple Sclerosis (MS) Attack

Primary Purpose

Multiple Sclerosis

Status
Terminated
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
methylprednisolone
Sodium chlorid
Sponsored by
Sykehuset Innlandet HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring EDSS, methylprednisolone, circadian rhythms, MSFC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Innlandet Hosptal Trust-Lillehammer, Neurological Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Both study arms receive both active treatment = methylprednisolone and an inactive treatment = Sodium chlorid (dummy)

Both arms receives both active treatment and inactive treatment = dummy. Active treatment is methylprednisolone, inactive treatment is sodium chlorid.

Outcomes

Primary Outcome Measures

The difference in mean changes in EDSS-score between the group receiving treatment during the night opposed to during the day.

Secondary Outcome Measures

The difference in MSFC-score in the two groups
Side effect registered by the patient
The patient's quality of life
MRI - volume and number for MS-lesions, Gd-enhancement
Fatigue
Depression

Full Information

First Posted
October 1, 2008
Last Updated
November 21, 2014
Sponsor
Sykehuset Innlandet HF
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1. Study Identification

Unique Protocol Identification Number
NCT00764413
Brief Title
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

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Terminated
Why Stopped
Low inclusion frequency and not enough human resources for completing study
Study Start Date
April 2009 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sykehuset Innlandet HF

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
EDSS, methylprednisolone, circadian rhythms, MSFC

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Both study arms receive both active treatment = methylprednisolone and an inactive treatment = Sodium chlorid (dummy)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Both arms receives both active treatment and inactive treatment = dummy. Active treatment is methylprednisolone, inactive treatment is sodium chlorid.
Intervention Type
Drug
Intervention Name(s)
methylprednisolone
Other Intervention Name(s)
Solu-Medrol. ACT-nr:H02A B04
Intervention Description
1 gram intravenous a day for 3 days
Intervention Type
Drug
Intervention Name(s)
Sodium chlorid
Other Intervention Name(s)
ATC: B05B B01
Intervention Description
Sodium chlorid 9mg/ml 500 ml per day in 3 days
Primary Outcome Measure Information:
Title
The difference in mean changes in EDSS-score between the group receiving treatment during the night opposed to during the day.
Time Frame
At admittion, directly after treatment, ca 30 days after treatment
Secondary Outcome Measure Information:
Title
The difference in MSFC-score in the two groups
Time Frame
At admittion, directly after treatment, ca 30 days after treatment
Title
Side effect registered by the patient
Time Frame
At admittion (baseline), during treatment, directly after treatment
Title
The patient's quality of life
Time Frame
At admittion, directly after treatment, 7 days and ca 30 days after treatment
Title
MRI - volume and number for MS-lesions, Gd-enhancement
Time Frame
At admission, directly after treatment and ca 30 days after treatment
Title
Fatigue
Time Frame
Before, after and ca 30 days after treatment
Title
Depression
Time Frame
Before, after and ca 30 days after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anette H Farmen, Physician/MD
Organizational Affiliation
Innlandet Hospital Trust Lillehammer, Neurological Department
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kristin I Løken-Amsrud, Physician/MD
Organizational Affiliation
Innlandet Hospital Trust Lillehammer, Neurological Department
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Elisabeth G Celius, MD/PhD
Organizational Affiliation
Oslo University Hospital, Ullevål, Neurological Department
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Per O Vandvik, MD/PhD
Organizational Affiliation
Innlandet Hospital Trust Gjøvik, Department of Internal medicin
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Trygve Holmøy, MD/PhD
Organizational Affiliation
Oslo University Hospital, Ullevål, Neurological department
Official's Role
Study Chair
Facility Information:
Facility Name
Innlandet Hosptal Trust-Lillehammer, Neurological Department
City
Lillehammer
State/Province
Oppland
ZIP/Postal Code
2609
Country
Norway

12. IPD Sharing Statement

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Chronotherapy in Acute Multiple Sclerosis (MS) Attack

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