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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Rigshospitalet, Denmark.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Danish Research Centre for Magnetic Resonance, Hvidovre.
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01144117
First received: June 7, 2010
Last updated: August 4, 2011
Last verified: May 2010
  Purpose

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 Intervention Phase
Multiple Sclerosis (Primary or Secondary Progressive Phase).
Drug: Erythropoietin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparisons between the placebo-and the EPO-group regarding:difference in maximum gait distance between baseline and week 24. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Comparisons between the placebo-and the EPO-group regarding:difference in 9-hole peg test [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Comparisons between the placebo-and the EPO-group regarding:difference in TRAIL making B [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 56
Study Start Date: November 2009
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Erythropoietin
Erythropoietin treated patients contra placebo.
Drug: Erythropoietin
Erythropoietin 48000 IU given I.V. in 17 courses
Other Name: Epo, NeoRecormon

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.

  Eligibility

Ages Eligible for Study:   19 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01144117

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

Locations
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, Hvidovre.
Investigators
Principal Investigator: Karen Schreiber, MD., Ph.d. Rigshospitalet, Denmark
Study Director: Per S Soerensen, MD., Prof Rigshospitalet, Denmark
  More Information

No publications provided

Responsible Party: Professor Per Soelberg Sorensen, Rigshospitalet., The Danish MS Research Center
ClinicalTrials.gov Identifier: NCT01144117     History of Changes
Other Study ID Numbers: EudraCT number: 2009-011516-37
Study First Received: June 7, 2010
Last Updated: August 4, 2011
Health Authority: Denmark: Danish Medicines Agency
Denmark: Danish Dataprotection Agency

Keywords provided by Rigshospitalet, Denmark:
Progressive Multiple Sclerosis

Additional relevant MeSH terms:
Brain Diseases
Multiple Sclerosis
Sclerosis
Central Nervous System Diseases
Nervous System Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014