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Chronotherapy in Acute Multiple Sclerosis (MS) Attack

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ClinicalTrials.gov Identifier: NCT00764413
Recruitment Status : Terminated (Low inclusion frequency and not enough human resources for completing study)
First Posted : October 2, 2008
Last Update Posted : November 24, 2014
Sponsor:
Information provided by (Responsible Party):
Sykehuset Innlandet HF

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: methylprednisolone Drug: Sodium chlorid Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment With Methylprednisolone in Acute Exacerbations of Multiple Sclerosis: Enhanced Effect With Nighttime Treatment?
Study Start Date : April 2009
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012


Arm Intervention/treatment
Active Comparator: 1
Both study arms receive both active treatment = methylprednisolone and an inactive treatment = Sodium chlorid (dummy)
Drug: methylprednisolone
1 gram intravenous a day for 3 days
Other Name: Solu-Medrol. ACT-nr:H02A B04
Drug: Sodium chlorid
Sodium chlorid 9mg/ml 500 ml per day in 3 days
Other Name: ATC: B05B B01
Active Comparator: 2
Both arms receives both active treatment and inactive treatment = dummy. Active treatment is methylprednisolone, inactive treatment is sodium chlorid.
Drug: methylprednisolone
1 gram intravenous a day for 3 days
Other Name: Solu-Medrol. ACT-nr:H02A B04
Drug: Sodium chlorid
Sodium chlorid 9mg/ml 500 ml per day in 3 days
Other Name: ATC: B05B B01



Primary Outcome Measures :
  1. The difference in mean changes in EDSS-score between the group receiving treatment during the night opposed to during the day. [ Time Frame: At admittion, directly after treatment, ca 30 days after treatment ]

Secondary Outcome Measures :
  1. The difference in MSFC-score in the two groups [ Time Frame: At admittion, directly after treatment, ca 30 days after treatment ]
  2. Side effect registered by the patient [ Time Frame: At admittion (baseline), during treatment, directly after treatment ]
  3. The patient`s quality of life [ Time Frame: At admittion, directly after treatment, 7 days and ca 30 days after treatment ]
  4. MRI - volume and number for MS-lesions, Gd-enhancement [ Time Frame: At admission, directly after treatment and ca 30 days after treatment ]
  5. Fatigue [ Time Frame: Before, after and ca 30 days after treatment ]
  6. Depression [ Time Frame: Before, after and ca 30 days after treatment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00764413


Locations
Norway
Innlandet Hosptal Trust-Lillehammer, Neurological Department
Lillehammer, Oppland, Norway, 2609
Sponsors and Collaborators
Sykehuset Innlandet HF
Investigators
Study Director: 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 Chair: 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

Responsible Party: Sykehuset Innlandet HF
ClinicalTrials.gov Identifier: NCT00764413     History of Changes
Other Study ID Numbers: 15002
150134 ( Other Grant/Funding Number: Innlandet Hospital Trust )
2008-002025-37 ( EudraCT Number )
First Posted: October 2, 2008    Key Record Dates
Last Update Posted: November 24, 2014
Last Verified: February 2014

Keywords provided by Sykehuset Innlandet HF:
EDSS
methylprednisolone
circadian rhythms
MSFC

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents