Chronotherapy in Acute Multiple Sclerosis (MS) Attack - Full Text View

Sponsored by:	Sykehuset Innlandet HF
Information provided by:	Sykehuset Innlandet HF
ClinicalTrials.gov Identifier:	NCT00764413

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

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Prednisolone 6-Methylprednisolone Depo-medrol Medrol veriderm Methylprednisolone Methylprednisolone hemisuccinate Methylprednisolone Sodium Succinate Prednisolone acetate Prednisolone sodium phosphate Prednisolone Sodium Succinate

U.S. FDA Resources

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

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, 7-10 days 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, 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 ]

Estimated Enrollment:	75
Study Start Date:	November 2008
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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 Drug: Sodium chlorid Sodium chlorid 9mg/ml 500 ml per day in 3 days
2: Active Comparator 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 Drug: Sodium chlorid Sodium chlorid 9mg/ml 500 ml per day in 3 days

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 og acute diseases) where treatment with intravenous steroids over short period of time is contraindicated of not favorable.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00764413

Contacts

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

Locations

Norway, Oppland
Sykehuset Innlandet HF-Lillehammer, Neurological Department
Lillehammer, Oppland, Norway, 2609

Sponsors and Collaborators

Sykehuset Innlandet HF

Investigators

Study Director:	Anette H Farmen, Physician/MD	Sykehuset (Hospital) Innlandet HF, Neurological Department
Study Director:	Kristin I Løken, Physician/MD	Sykehuset Innlandet HF, Neurological Department
Study Chair:	Elisabeth G Celius, MD/PhD	Ullevål University Hospital, Neurological Department
Study Chair:	Per O Vandvik, MD/PhD	Sykehuset Innlandet HF-Gjøvik, Department of Internal medicin

More Information

Responsible Party:	Sykehuset Innlandet HF ( Anette Huuse Farmen )
Study ID Numbers:	15002, EUDRACT: 2009-002025-37
Study First Received:	October 1, 2008
Last Updated:	October 1, 2008
ClinicalTrials.gov Identifier:	NCT00764413
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

Study placed in the following topic categories:

Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Methylprednisolone
Prednisolone
Methylprednisolone acetate

Demyelinating Autoimmune Diseases, CNS
Prednisolone acetate
Demyelinating diseases
Sclerosis
Autoimmune Diseases of the Nervous System
Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Immune System Diseases
Antineoplastic Agents
Nervous System Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents
Antiemetics
Hormones

Glucocorticoids
Protective Agents
Neuroprotective Agents
Pharmacologic Actions
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 13, 2009