Chronotherapy in Acute Multiple Sclerosis (MS) Attack

Sykehuset Innlandet HF

Status: Terminated

Conditions: Multiple Sclerosis

Treatments: Drug: Sodium chlorid; Drug: methylprednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT00764413

15002

2008-002025-37 (EudraCT Number)

150134 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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57 participants in 2 patient groups

1

Active Comparator group

Description:

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

Treatment:

Drug: methylprednisolone

Drug: Sodium chlorid

2

Active Comparator group

Description:

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

Treatment:

Drug: methylprednisolone

Drug: Sodium chlorid