Chronotherapy in Acute Multiple Sclerosis (MS) Attack

This study has suspended participant recruitment.
(Low inclusion frequency)
Sponsor:
Information provided by (Responsible Party):
Sykehuset Innlandet HF
ClinicalTrials.gov Identifier:
NCT00764413
First received: October 1, 2008
Last updated: February 17, 2014
Last verified: February 2014

October 1, 2008
February 17, 2014
April 2009
December 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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, 7-10 days after treatment, ca 30 days after treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00764413 on ClinicalTrials.gov Archive Site
  • The difference in MSFC-score in the two groups [ Time Frame: At admittion, directly after treatment, ca 30 days after treatment ] [ Designated as safety issue: No ]
  • Side effect registered by the patient [ Time Frame: At admittion (baseline), during treatment, directly after treatment ] [ Designated as safety issue: No ]
  • The patient`s quality of life [ Time Frame: At admittion, directly after treatment, 7 days and ca 30 days after treatment ] [ Designated as safety issue: No ]
  • MRI - volume and number for MS-lesions, Gd-enhancement [ Time Frame: At admission, directly after treatment and ca 30 days after treatment ] [ Designated as safety issue: No ]
  • Fatigue [ Time Frame: Before, after and ca 30 days after treatment ] [ Designated as safety issue: No ]
  • Depression [ Time Frame: Before, after and ca 30 days after treatment ] [ Designated as safety issue: No ]
  • The difference in MSFC-score in the two groups [ Time Frame: At admittion, 7-10 days after treatment, ca 30 days after treatment ] [ Designated as safety issue: No ]
  • Side effect registered by the patient [ Time Frame: At admittion (baseline), during treatment, 7-10 days after treatment og ca 30 days after treatment. ] [ Designated as safety issue: No ]
  • The patient`s quality of life [ Time Frame: At admittion, before discharge, 7-10 days and ca 30 days after treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Multiple Sclerosis
  • Drug: methylprednisolone
    1 gram intravenous a day for 3 days
    Other Name: Solu-Medrol. ACT-nr:H02A B04
  • Drug: Sodium chlorid
    Sodium chlorid 9mg/ml 500 ml per day in 3 days
    Other Name: ATC: B05B B01
  • Active Comparator: 1
    Both study arms receive both active treatment = methylprednisolone and an inactive treatment = Sodium chlorid (dummy)
    Interventions:
    • Drug: methylprednisolone
    • Drug: Sodium chlorid
  • Active Comparator: 2
    Both arms receives both active treatment and inactive treatment = dummy. Active treatment is methylprednisolone, inactive treatment is sodium chlorid.
    Interventions:
    • Drug: methylprednisolone
    • Drug: Sodium chlorid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
57
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00764413
15002, 150134, 2008-002025-37
No
Sykehuset Innlandet HF
Sykehuset Innlandet HF
Not Provided
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
Sykehuset Innlandet HF
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP