Chronotherapy in Acute Multiple Sclerosis (MS) Attack

NCT00764413 | Terminated

• 3 other identifiers: 150021501342008-002025-37
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

EDSS; methylprednisolone; circadian rhythms; MSFC

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• 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

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

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

Drug: methylprednisolone; Drug: Sodium chlorid

2

ACTIVE COMPARATOR

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

Drug: methylprednisolone; Drug: Sodium chlorid

Interventions

methylprednisolone DRUG

1 gram intravenous a day for 3 days

Also known as: Solu-Medrol. ACT-nr:H02A B04

1; 2

Sodium chlorid DRUG

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

Also known as: ATC: B05B B01

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sykehuset Innlandet HF: lead

Study Sites (1)

Innlandet Hosptal Trust-Lillehammer, Neurological Department

Lillehammer, Oppland, 2609, Norway

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2008
• First Posted: October 2, 2008
• Study Start: April 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: November 24, 2014

Record last verified: 2014-02

Locations

NO (1)