Multiple Sclerosis (Primary or Secondary Progressive Phase).Phase 2EPO-ProgMSNCT01144117
The Effects of Erythropoietin on Clinical Disability and Brain Pathology in Patients With Progressive Multiple Sclerosis
A Phase 2 study testing Erythropoietin in people with Multiple Sclerosis (Primary or Secondary Progressive Phase)., run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Multiple Sclerosis (Primary or Secondary Progressive Phase).
- What is being tested?
- Erythropoietin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2009to Apr 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Karen Schreiber
Copenhagen, Oesterbro, DK-2100
Karen Schreiber, MD., Ph.d., +45 35 45 98 40, karen.schreiber@rh.dk
Karen Schreiber, MD., Ph.d.
About this study
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
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.
Read the 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.
- Being tested
- Erythropoietin
- Keywords
- Progressive Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Chronic Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErythropoietinDrug
Also called Epo, NeoRecormon
Erythropoietin 48000 IU given I.V. in 17 courses
| Study group | Role | What they receive |
|---|---|---|
| Erythropoietin | Experimental | Erythropoietin treated patients contra placebo. Receives: Drug: Erythropoietin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 weeks
Secondary outcomes (3)
Comparisons between the placebo-and the EPO-group regarding:difference in maximum gait distance between baseline and week 24.
Measured: 48 weeks
Comparisons between the placebo-and the EPO-group regarding:difference in 9-hole peg test
Measured: 48 weeks
Comparisons between the placebo-and the EPO-group regarding:difference in TRAIL making B
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2010 (estimated)
- Study startNov 2009
- Primary completionDec 2012 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis (Primary or Secondary Progressive Phase).Studies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Research Centre for Magnetic Resonance
- Investigators
- Karen Schreiber, MD., Ph.d., Principal investigator, Copenhagen University Hospital, RigshospitaletPer S Soerensen, MD., Prof, Study director, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01144117
- Sponsor's protocol ID
- EudraCT number: 2009-011516-37
- Acronym
- EPO-ProgMS
- Status last verified
- May 2010
- First submitted
- 7 Jun 2010
- Last updated
- 8 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01144117
- Acronym / sponsor ID
- EPO-ProgMS / EudraCT number: 2009-011516-37
- Keywords
- Progressive Multiple Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Danish Research Centre for Magnetic Resonance
- Study start
- Nov 2009
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 15 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erythropoietin | Experimental | Drug: ErythropoietinErythropoietin treated patients contra placebo. |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErythropoietinAlso: Epo, NeoRecormonErythropoietin 48000 IU given I.V. in 17 courses | Drug | Erythropoietin |
Primary outcome
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
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2011.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Schreiber, MD., Ph.d. principal investigator
Copenhagen University Hospital, Rigshospitalet
Per S Soerensen, MD., Prof study director
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Erythropoietin in people with Multiple Sclerosis (Primary or Secondary Progressive Phase)., run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karen Schreiber, M.D., Ph.d. (+45 35 45 98 40, karen.schreiber@rh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2011.