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

Primary Purpose

Multiple Sclerosis (Primary or Secondary Progressive Phase).

Status

Unknown status

Phase

Phase 2

Locations

Denmark

Study Type

Interventional

Intervention

Erythropoietin

About this trial

This is an interventional treatment trial for Multiple Sclerosis (Primary or Secondary Progressive Phase). focused on measuring Progressive Multiple Sclerosis

Eligibility Criteria

19 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Karen SchreiberRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Erythropoietin

Arm Description

Erythropoietin treated patients contra placebo.

Outcomes

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.

Secondary Outcome Measures

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

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

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

Full Information

NCT ID

NCT01144117

First Posted

June 7, 2010

Last Updated

August 4, 2011

Sponsor

Rigshospitalet, Denmark

Collaborators

Danish Research Centre for Magnetic Resonance

1. Study Identification

Unique Protocol Identification Number

NCT01144117

Brief Title

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

Acronym

EPO-ProgMS

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 Type

Interventional

2. Study Status

Record Verification Date

May 2010

Overall Recruitment Status

Unknown status

Study Start Date

November 2009 (undefined)

Primary Completion Date

December 2012 (Anticipated)

Study Completion Date

April 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Rigshospitalet, Denmark

Collaborators

Danish Research Centre for Magnetic Resonance

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis (Primary or Secondary Progressive Phase).

Keywords

Progressive Multiple Sclerosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Erythropoietin

Arm Type

Experimental

Arm Description

Erythropoietin treated patients contra placebo.

Intervention Type

Drug

Intervention Name(s)

Erythropoietin

Other Intervention Name(s)

Epo, NeoRecormon

Intervention Description

Erythropoietin 48000 IU given I.V. in 17 courses

Primary Outcome Measure Information:

Title

Time Frame

48 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

48 weeks

Title

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

Time Frame

48 weeks

Title

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

Time Frame

48 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

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

Phone

+45 35 45 98 40

karen.schreiber@rh.dk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karen Schreiber, MD., Ph.d.

Organizational Affiliation

Rigshospitalet, Denmark

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Per S Soerensen, MD., Prof

Organizational Affiliation

Rigshospitalet, Denmark

Official's Role

Study Director

Facility Information:

Facility Name

Karen Schreiber

City

Copenhagen

State/Province

Oesterbro

ZIP/Postal Code

DK-2100

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Karen Schreiber, MD., Ph.d.

Phone

+45 35 45 98 40

karen.schreiber@rh.dk

First Name & Middle Initial & Last Name & Degree

Karen Schreiber, MD., Ph.d.

12. IPD Sharing Statement

Learn more about this trial

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

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