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Trial record 1 of 6 for:    erythropoietin multiple sclerosis
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The Effects of Erythropoietin on Clinical Disability and Brain Pathology in Patients With Progressive Multiple Sclerosis (EPO-ProgMS)

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ClinicalTrials.gov Identifier: NCT01144117
Recruitment Status : Unknown
Verified May 2010 by Rigshospitalet, Denmark.
Recruitment status was:  Recruiting
First Posted : June 15, 2010
Last Update Posted : August 8, 2011
Sponsor:
Collaborator:
Danish Research Centre for Magnetic Resonance
Information provided by:
Rigshospitalet, Denmark

Study Description
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Brief Summary:
In a double-blind, placebo-controlled, parallel group trial, recombinant human erythropoietin (rhEPO) (48000 IU) treatment or placebo will be administered weekly i.v. for 24 weeks: weekly for 12 weeks and bi-weekly for 12 weeks. Methylprednisolone (MP) 1 g i.v. will be administered before the first and second EPO/placebo administration. The 24-week treatment period will be followed by a 24-week observation period.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis (Primary or Secondary Progressive Phase). Drug: Erythropoietin Phase 2

Detailed Description:

Patients with primary progressive MS or secondary progressive MS without relapses during the last 1 year will be suitable for the trial. In all 56 patients will be enrolled into the study.

The primary outcome measure is the change from baseline to 24 weeks in a composite of maximum gait distance, 9-hole peg test, TRAIL making B comparing the placebo-treatment group with the EPO-treatment group.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double Blind, Placebo-controlled Study to Assess the Effects of Erythropoietin on Clinical Disability and Brain Pathology as Shown by Magnetic Resonance Imaging in Patients With Progressive Multiple Sclerosis
Study Start Date : November 2009
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : April 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Erythropoietin
Erythropoietin treated patients contra placebo.
 Drug: Erythropoietin
Erythropoietin 48000 IU given I.V. in 17 courses
Other Name: Epo, NeoRecormon


Outcome Measures
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Primary Outcome Measures :
  1. The primary outcome measure is the change from baseline to 24 weeks in a composite of maximum gait distance, 9-hole peg test, TRAIL making B comparing the placebo-treatment group with the EPO-treatment group. [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  1. Comparisons between the placebo-and the EPO-group regarding:difference in maximum gait distance between baseline and week 24. [ Time Frame: 48 weeks ]
  2. Comparisons between the placebo-and the EPO-group regarding:difference in 9-hole peg test [ Time Frame: 48 weeks ]
  3. Comparisons between the placebo-and the EPO-group regarding:difference in TRAIL making B [ Time Frame: 48 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age between 19 and 60 years
  • primary progressive MS or secondary progressive MS without relapses during the last one year
  • duration of the disease of at least 2 years Clinical disability progression should have been observed in the 2 years prior to screening as per clinical judgment of the investigator. In addition, progression must be documented by an increase in the EDSS score of at least 0.5 points at any time during the 2 years prior to Screening; or progression of 1 point in the pyramidal, cerebellar, brain stem , visual or sensory functional system during the last 2 years. Should documented EDSS scores not be available, a written summary of the clinical evidence of disability progression in the previous 2 years must be submitted (for example walking distance or hand function).
  • EDSS (Expanded Disability Status Scale) 4.0-6.5
  • MRI fulfilling the Barkhof criteria for MS
  • written informed consent

Exclusion Criteria:

  • pregnancy or period of breastfeeding or missing adequate contraceptive protection
  • treatment with steroids in the last 30 days
  • treatment with interferons, glatiramer acetate or IVIG in the last1 month prior to enrolment
  • treatment with azathioprin, mitoxantrone or any other immuno-suppressive in the 6 months prior to enrolment
  • cardiac insufficiency (NYHA III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, instable or advanced ischemic heart disease (CCS III or IV), malignant hypertension (systolic > 180, diastolic > 110)
  • history of any haematological disorder
  • history of renal insufficiency
  • any medical psychiatric or other circumstances which impede or restrict the subjects participation in the study in the manner intended
  • contraindication for contrast enhanced MRI (e.g. pace maker, aortic clip or any metal implant)
Contacts and Locations
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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): NCT01144117


Contacts
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Contact: Karen Schreiber, M.D., Ph.d. +45 35 45 98 40 karen.schreiber@rh.dk

Locations
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Denmark
Karen Schreiber Recruiting
Copenhagen, Oesterbro, Denmark, DK-2100
Contact: Karen Schreiber, MD., Ph.d.    +45 35 45 98 40    karen.schreiber@rh.dk   
Principal Investigator: Karen Schreiber, MD., Ph.d.         
Sponsors and Collaborators
Rigshospitalet, Denmark
Danish Research Centre for Magnetic Resonance
Investigators
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Principal Investigator: Karen Schreiber, MD., Ph.d. Rigshospitalet, Denmark
Study Director: Per S Soerensen, MD., Prof Rigshospitalet, Denmark
More Information
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Responsible Party: Professor Per Soelberg Sorensen, Rigshospitalet., The Danish MS Research Center
ClinicalTrials.gov Identifier: NCT01144117    
Other Study ID Numbers: EudraCT number: 2009-011516-37
First Posted: June 15, 2010    Key Record Dates
Last Update Posted: August 8, 2011
Last Verified: May 2010
Keywords provided by Rigshospitalet, Denmark:
Progressive Multiple Sclerosis
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Sclerosis
Epoetin Alfa
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Chronic Disease
Disease Attributes
Hematinics