The Effects of Erythropoietin on Clinical Disability and Brain Pathology in Patients With Progressive Multiple Sclerosis (EPO-ProgMS)

August 4, 2011 updated by: Rigshospitalet, Denmark

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

56

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Oesterbro
      • Copenhagen, Oesterbro, Denmark, DK-2100
        • Recruiting
        • Karen Schreiber
        • Contact:
        • Principal Investigator:
          • Karen Schreiber, MD., Ph.d.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Erythropoietin
Erythropoietin treated patients contra placebo.
Drug: Erythropoietin
Erythropoietin 48000 IU given I.V. in 17 courses
Other Names:
  • Epo, NeoRecormon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
48 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparisons between the placebo-and the EPO-group regarding:difference in maximum gait distance between baseline and week 24.
Time Frame: 48 weeks
48 weeks
Comparisons between the placebo-and the EPO-group regarding:difference in 9-hole peg test
Time Frame: 48 weeks
48 weeks
Comparisons between the placebo-and the EPO-group regarding:difference in TRAIL making B
Time Frame: 48 weeks
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

Danish Research Centre for Magnetic Resonance

Investigators

  • Principal Investigator: Karen Schreiber, MD., Ph.d., Rigshospitalet, Denmark
  • Study Director: Per S Soerensen, MD., Prof, Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

April 1, 2013

Study Registration Dates

First Submitted

June 7, 2010

First Submitted That Met QC Criteria

June 14, 2010

First Posted (Estimate)

June 15, 2010

Study Record Updates

Last Update Posted (Estimate)

August 8, 2011

Last Update Submitted That Met QC Criteria

August 4, 2011

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT number: 2009-011516-37

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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