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Sponsored by: |
Sykehuset Innlandet HF |
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Information provided by: | Sykehuset Innlandet HF |
ClinicalTrials.gov Identifier: | NCT00764413 |
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 |
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Multiple Sclerosis |
Drug: methylprednisolone Drug: Sodium chlorid |
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? |
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 |
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1: Active Comparator
Both study arms receive both active treatment = methylprednisolone and an inactive treatment = Sodium chlorid (dummy)
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Drug: methylprednisolone
1 gram intravenous a day for 3 days
Drug: Sodium chlorid
Sodium chlorid 9mg/ml 500 ml per day in 3 days
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2: Active Comparator
Both arms receives both active treatment and inactive treatment = dummy. Active treatment is methylprednisolone, inactive treatment is sodium chlorid.
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Drug: methylprednisolone
1 gram intravenous a day for 3 days
Drug: Sodium chlorid
Sodium chlorid 9mg/ml 500 ml per day in 3 days
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Norway, Oppland | |
Sykehuset Innlandet HF-Lillehammer, Neurological Department | |
Lillehammer, Oppland, Norway, 2609 |
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 |
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 |
EDSS methylprednisolone circadian rhythms MSFC |
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 |
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 |