Chronotherapy in Acute Multiple Sclerosis (MS) Attack

Multiple Sclerosis Clinical Trial

Official title:

Treatment With Methylprednisolone in Acute Exacerbations of Multiple Sclerosis: Enhanced Effect With Nighttime Treatment?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00764413
• Other study ID #: 15002
• Secondary ID: 1501342008-00202
• Status: Terminated
• Phase: N/A
• First received: October 1, 2008
• Last updated: November 21, 2014
• Start date: April 2009
• Est. completion date: July 2012

Study information

• Verified date: February 2014
• Source: Sykehuset Innlandet HF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines AgencyNorway: Regional Ethics ComiteeNorway: The Data Inspectorate at Ullevål University Hospital
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 57
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• methylprednisolone
1 gram intravenous a day for 3 days
• Sodium chlorid
Sodium chlorid 9mg/ml 500 ml per day in 3 days

Locations

Country	Name	City	State
Norway	Innlandet Hosptal Trust-Lillehammer, Neurological Department	Lillehammer	Oppland

Sponsors (1)

Lead Sponsor	Collaborator
Sykehuset Innlandet HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The difference in MSFC-score in the two groups		At admittion, directly after treatment, ca 30 days after treatment	No
Secondary	Side effect registered by the patient		At admittion (baseline), during treatment, directly after treatment	No
Secondary	The patient`s quality of life		At admittion, directly after treatment, 7 days and ca 30 days after treatment	No
Secondary	MRI - volume and number for MS-lesions, Gd-enhancement		At admission, directly after treatment and ca 30 days after treatment	No
Secondary	Fatigue		Before, after and ca 30 days after treatment	No
Secondary	Depression		Before, after and ca 30 days after treatment	No