The Effects of Erythropoietin on Clinical Disability and Brain Pathology in Patients With Progressive Multiple Sclerosis

NCT01144117 | Unknown Phase 2 DMC

• 1 other identifier: EudraCT number: 2009-011516-37
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis (Primary or Secondary Progressive Phase).

Keywords

Progressive Multiple Sclerosis

Outcome Measures

Primary Outcomes (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.

  48 weeks

Secondary Outcomes (3)

• Comparisons between the placebo-and the EPO-group regarding:difference in maximum gait distance between baseline and week 24.

  48 weeks

• Comparisons between the placebo-and the EPO-group regarding:difference in 9-hole peg test

  48 weeks

• Comparisons between the placebo-and the EPO-group regarding:difference in TRAIL making B

  48 weeks

Study Arms (1)

Erythropoietin

EXPERIMENTAL

Erythropoietin treated patients contra placebo.

Drug: Erythropoietin

Interventions

Erythropoietin DRUG

Erythropoietin 48000 IU given I.V. in 17 courses

Also known as: Epo, NeoRecormon

Erythropoietin

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Danish Research Centre for Magnetic Resonance: collaborator

Study Sites (1)

Karen Schreiber

Copenhagen, Oesterbro, DK-2100, Denmark

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive

Interventions

Erythropoietin; Eosinophil Peroxidase; epoetin beta

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)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Peroxidases; Oxidoreductases; Enzymes; Enzymes and Coenzymes; Eosinophil Granule Proteins; Immunoproteins; Blood Proteins

Study Officials

• Karen Schreiber, MD., Ph.d.

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

• Per S Soerensen, MD., Prof

  Rigshospitalet, Denmark

  STUDY DIRECTOR

Central Study Contacts

Karen Schreiber, M.D., Ph.d.

CONTACT

+45 35 45 98 40; karen.schreiber@rh.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 7, 2010
• First Posted: June 15, 2010
• Study Start: November 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: April 1, 2013
• Last Updated: August 8, 2011

Record last verified: 2010-05

Locations

DK (1)