Cyclic Oral Methylprednisolone Trial in Multiple Sclerosis

NCT01305837 | Completed Phase 2 DMC

• 2 other identifiers: 2010-3702010-024561-43
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether cyclic oral methylprednisolone once every month has an effect on the intrathecal inflammation in patients suffering from progressive multiple sclerosis.

Conditions

Progressive Multiple Sclerosis

Keywords

multiple sclerosis; methylprednisolone; osteopontin; inflammation; demyelinating

Outcome Measures

Primary Outcomes (1)

• CSF osteopontin

  baseline and week 60

Secondary Outcomes (4)

• aims for clinical progression

  baseline and week 60

• aims for demyelination and disease activity

  baseline, week 12 (only MRI aims and MEP) and week 60

• aims of intrathecal inflammation

  baseline and week 60

• safety

  screnning, baseline, week 12, 24, 36, 48, 60

Study Arms (1)

methylprednisolone

EXPERIMENTAL

all patients will be treated with the active drug methylprednisolone 500 mg in 3 days every month for 60 weeks.

Drug: methylprednisolone

Interventions

methylprednisolone DRUG

500 mg of methylprednisolone taken in 3 days every month

Also known as: Medrol

methylprednisolone

Eligibility Criteria

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

You may qualify if:

• Age between 18 and 65 years old
• Progressive form of MS (Eg. primary or secondary progressive MS)
• Duration of progressive phase at least 1 year
• Progression of at least 1 EDSS point for the last 2 years or at least ½ EDSS point in patients with EDSS \> 5,5
• Progressin in 2 FS point
• EDSS \</= 6,5
• Signed informed consent and written authority

You may not qualify if:

• Pregnancy and breast feeding
• Lack of secure contraception for women of child-bearing age (hormonal or intrauterine device)
• Previous treatment with drugs which the treating physician finds could have influence on the study results
• Diseases associated with immune defects
• Treatment with other anticoagulant than acetyl salicyl acid
• Malignancy
• Diabetes Mellitus
• Renal insufficiency or S-Creatinine \> 150 mmol/l
• Acute or chronic infections with hepatitis B og C virus, HIV or other infections which the treating physician finds relevant
• Psychiatric illness or other conditions which can impair the collaboration of the patient participating in the study
• Contra-indication to MRI
• Hypersensitivity to methylprednisolone
• Osteoporosis

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Scleroseklinikken, Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive; Multiple Sclerosis; Inflammation

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; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Rikke Ratzer, MD

  Scleroseklinikken, Rigshospitalet

  PRINCIPAL INVESTIGATOR

• Per S Sørensen, Professor, MD

  Scleroseklinikken, Rigshospitalet

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 28, 2011
• First Posted: March 1, 2011
• Study Start: April 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 11, 2013

Record last verified: 2013-07

Locations

DK (1)