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| ID | Type | Description | Link |
|---|---|---|---|
| 150134 | Other Grant/Funding Number | Innlandet Hospital Trust | |
| 2008-002025-37 | EudraCT Number |
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Low inclusion frequency and not enough human resources for completing study
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Both study arms receive both active treatment = methylprednisolone and an inactive treatment = Sodium chlorid (dummy) |
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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methylprednisolone | Drug | 1 gram intravenous a day for 3 days |
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| Measure | Description | Time Frame |
|---|---|---|
| The difference in mean changes in EDSS-score between the group receiving treatment during the night opposed to during the day. | At admittion, directly after treatment, ca 30 days after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| The difference in MSFC-score in the two groups | At admittion, directly after treatment, ca 30 days after treatment | |
| Side effect registered by the patient | At admittion (baseline), during treatment, directly after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 Director |
| 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 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Innlandet Hosptal Trust-Lillehammer, Neurological Department | Lillehammer | Oppland | 2609 | Norway |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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| Sodium chlorid | Drug | Sodium chlorid 9mg/ml 500 ml per day in 3 days |
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| The patient's quality of life | At admittion, directly after treatment, 7 days and ca 30 days after treatment |
| MRI - volume and number for MS-lesions, Gd-enhancement | At admission, directly after treatment and ca 30 days after treatment |
| Fatigue | Before, after and ca 30 days after treatment |
| Depression | Before, after and ca 30 days after treatment |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |