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Chronotherapy in Acute Multiple Sclerosis (MS) Attack

NCT ID: NCT00764413

Last Updated: 2014-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Both study arms receive both active treatment = methylprednisolone and an inactive treatment = Sodium chlorid (dummy)

Group Type ACTIVE_COMPARATOR

methylprednisolone

Intervention Type DRUG

1 gram intravenous a day for 3 days

Sodium chlorid

Intervention Type DRUG

Sodium chlorid 9mg/ml 500 ml per day in 3 days

2

Both arms receives both active treatment and inactive treatment = dummy. Active treatment is methylprednisolone, inactive treatment is sodium chlorid.

Group Type ACTIVE_COMPARATOR

methylprednisolone

Intervention Type DRUG

1 gram intravenous a day for 3 days

Sodium chlorid

Intervention Type DRUG

Sodium chlorid 9mg/ml 500 ml per day in 3 days

Interventions

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methylprednisolone

1 gram intravenous a day for 3 days

Intervention Type DRUG

Sodium chlorid

Sodium chlorid 9mg/ml 500 ml per day in 3 days

Intervention Type DRUG

Other Intervention Names

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Solu-Medrol. ACT-nr:H02A B04 ATC: B05B B01

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sykehuset Innlandet HF

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anette H Farmen, Physician/MD

Role: STUDY_DIRECTOR

Innlandet Hospital Trust Lillehammer, Neurological Department

Kristin I Løken-Amsrud, Physician/MD

Role: STUDY_DIRECTOR

Innlandet Hospital Trust Lillehammer, Neurological Department

Elisabeth G Celius, MD/PhD

Role: STUDY_CHAIR

Oslo University Hospital, Ullevål, Neurological Department

Per O Vandvik, MD/PhD

Role: STUDY_CHAIR

Innlandet Hospital Trust Gjøvik, Department of Internal medicin

Trygve Holmøy, MD/PhD

Role: STUDY_CHAIR

Oslo University Hospital, Ullevål, Neurological department

Locations

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Innlandet Hosptal Trust-Lillehammer, Neurological Department

Lillehammer, Oppland, Norway

Site Status

Countries

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Norway

Other Identifiers

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150134

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2008-002025-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

15002

Identifier Type: -

Identifier Source: org_study_id