Clinical trial NCT01144117: The Effects of Erythropoietin on Clinical Disability and Brain Pathology in Patients With Progressive Multiple Sclerosis
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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Multiple Sclerosis (Primary or Secondary Progressive Phase).
Keywords: Progressive Multiple Sclerosis
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Danish Research Centre for Magnetic Resonance
First posted: 2010-06-15
Enrollment: 56
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
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.
timeFrame: 48 weeks
Secondary outcomes:
measure: Comparisons between the placebo-and the EPO-group regarding:difference in maximum gait distance between baseline and week 24.
timeFrame: 48 weeks
measure: Comparisons between the placebo-and the EPO-group regarding:difference in 9-hole peg test
timeFrame: 48 weeks
measure: Comparisons between the placebo-and the EPO-group regarding:difference in TRAIL making B
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Karen Schreiber
state: Oesterbro
Study officials:
affiliation: Rigshospitalet, Denmark
name: Karen Schreiber, MD., Ph.d.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet, Denmark
name: Per S Soerensen, MD., Prof
role: STUDY_DIRECTOR
References: