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Chronotherapy in Acute Multiple Sclerosis (MS) Attack

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ClinicalTrials.gov Identifier: NCT00764413
Recruitment Status : Terminated (Low inclusion frequency and not enough human resources for completing study)
First Posted : October 2, 2008
Last Update Posted : November 24, 2014
Sponsor:
Information provided by (Responsible Party):
Sykehuset Innlandet HF

Tracking Information
First Submitted Date  ICMJE October 1, 2008
First Posted Date  ICMJE October 2, 2008
Last Update Posted Date November 24, 2014
Study Start Date  ICMJE April 2009
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2009)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 1, 2008)
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 ]
Change History Complete list of historical versions of study NCT00764413 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2009)
  • The difference in MSFC-score in the two groups [ Time Frame: At admittion, directly after treatment, ca 30 days after treatment ]
  • Side effect registered by the patient [ Time Frame: At admittion (baseline), during treatment, directly after treatment ]
  • The patient`s quality of life [ Time Frame: At admittion, directly after treatment, 7 days and ca 30 days after treatment ]
  • MRI - volume and number for MS-lesions, Gd-enhancement [ Time Frame: At admission, directly after treatment and ca 30 days after treatment ]
  • Fatigue [ Time Frame: Before, after and ca 30 days after treatment ]
  • Depression [ Time Frame: Before, after and ca 30 days after treatment ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2008)
  • The difference in MSFC-score in the two groups [ Time Frame: At admittion, 7-10 days after treatment, ca 30 days after treatment ]
  • Side effect registered by the patient [ Time Frame: At admittion (baseline), during treatment, 7-10 days after treatment og ca 30 days after treatment. ]
  • The patient`s quality of life [ Time Frame: At admittion, before discharge, 7-10 days and ca 30 days after treatment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Chronotherapy in Acute Multiple Sclerosis (MS) Attack
Official Title  ICMJE Treatment With Methylprednisolone in Acute Exacerbations of Multiple Sclerosis: Enhanced Effect With Nighttime Treatment?
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 6, 2014)
57
Original Estimated Enrollment  ICMJE
 (submitted: October 1, 2008)
75
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00764413
Other Study ID Numbers  ICMJE 15002
150134 ( Other Grant/Funding Number: Innlandet Hospital Trust )
2008-002025-37 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sykehuset Innlandet HF
Study Sponsor  ICMJE Sykehuset Innlandet HF
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Sykehuset Innlandet HF
Verification Date February 2014

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