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Chronotherapy in Acute Multiple Sclerosis (MS) Attack

This study is currently recruiting participants.
Verified June 2011 by Sykehuset Innlandet HF
Sponsor:
Information provided by:
Sykehuset Innlandet HF
ClinicalTrials.gov Identifier:
NCT00764413
First received: October 1, 2008
Last updated: June 14, 2011
Last verified: June 2011
History of Changes
  Purpose

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. 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.


Condition Intervention
Multiple Sclerosis
 Drug: methylprednisolone
Drug: Sodium chlorid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment With Methylprednisolone in Acute Exacerbations of Multiple Sclerosis: Enhanced Effect With Nighttime Treatment?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sykehuset Innlandet HF:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 75
Study Start Date: April 2009
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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: 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 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00764413

Contacts
Contact: Kristin I Løken, Physician/MD +4761250254 kristin.loken@sykehuset-innlandet.no
Contact: Anette H Farmen, Physician/MD +4761250253 anette.huuse.farmen@sykehuset-innlandet.no

Locations
Norway
Innlandet Hosptal Trust-Lillehammer, Neurological Department Recruiting
Lillehammer, Oppland, Norway, 2609
Contact: Kristin I Løken, Physician/MD     +47612502534 ext +4799291474     kristin.loken@sykehuset-innlandet.no    
Contact: Anette H Farmen, Physician/MD     +4761250253 ext +4792201208     anette.huuse.farmen@sykehuset-innlandet.no    
Sub-Investigator: Anette H Farmen, Physician/MD            
Principal Investigator: Kristin I Løken, Physician/MD            
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Kristin Ingeleiv Løken-Amsrud, Sykehuset Innlandet HF
ClinicalTrials.gov Identifier: NCT00764413     History of Changes
Other Study ID Numbers: 15002, EUDRACT: 2009-002025-37
Study First Received: October 1, 2008
Last Updated: June 14, 2011
Health Authority: Norway: Norwegian Medicines Agency
Norway: Regional Ethics Comitee
Norway: The Data Inspectorate at Ullevål University Hospital

Keywords provided by Sykehuset Innlandet HF:
EDSS
methylprednisolone
circadian rhythms
MSFC

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
 Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on May 19, 2013