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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

Tracking Information
First Submitted Date  ICMJE June 7, 2010
First Posted Date  ICMJE June 15, 2010
Last Update Posted Date August 8, 2011
Study Start Date  ICMJE November 2009
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2010)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2010)
  • Comparisons between the placebo-and the EPO-group regarding:difference in maximum gait distance between baseline and week 24. [ Time Frame: 48 weeks ]
  • Comparisons between the placebo-and the EPO-group regarding:difference in 9-hole peg test [ Time Frame: 48 weeks ]
  • Comparisons between the placebo-and the EPO-group regarding:difference in TRAIL making B [ Time Frame: 48 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Erythropoietin on Clinical Disability and Brain Pathology in Patients With Progressive Multiple Sclerosis
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis (Primary or Secondary Progressive Phase).
Intervention  ICMJE Drug: Erythropoietin
Erythropoietin 48000 IU given I.V. in 17 courses
Other Name: Epo, NeoRecormon
Study Arms  ICMJE Experimental: Erythropoietin
Erythropoietin treated patients contra placebo.
Intervention: Drug: Erythropoietin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 14, 2010)
56
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2013
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01144117
Other Study ID Numbers  ICMJE EudraCT number: 2009-011516-37
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Professor Per Soelberg Sorensen, Rigshospitalet., The Danish MS Research Center
Study Sponsor  ICMJE Rigshospitalet, Denmark
Collaborators  ICMJE Danish Research Centre for Magnetic Resonance
Investigators  ICMJE
Principal Investigator: Karen Schreiber, MD., Ph.d. Rigshospitalet, Denmark
Study Director: Per S Soerensen, MD., Prof Rigshospitalet, Denmark
PRS Account Rigshospitalet, Denmark
Verification Date May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP