EUCTR2008-005125-11-GB
Active, not recruiting
Not Applicable
A pilot single-centre randomised controlled trial of recombinant human erythropoietin versus placebo in primary progressive multiple sclerosis.
Walton Centre for Neurology and Neurosurgery0 sitesJanuary 7, 2009
ConditionsPrimary progressive multiple sclerosisMedDRA version: 9.1Level: LLTClassification code 10063401Term: Primary progressive multiple sclerosis
DrugsNeorecormon
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Primary progressive multiple sclerosis
- Sponsor
- Walton Centre for Neurology and Neurosurgery
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Definite MS as determined by the McDonald criteria (Ann Neurol, July 2001\)With a primary progressive disease course.
- •18 to 65 years of age
- •EDSS 3 – 6\.5
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •Patients who are smokers. Ex\-smokers will be required to have stopped smoking for at least 1 month.
- •Patients with any medical or psychiatric conditions that would make the patient unsuitable for this research, as determined by the investigator.
- •Patients taking sex steroid hormones.
- •Patients taking iron supplements.
- •Patients previously treated with rhEPO who developed a pure red cell aplasia.
- •Patients taking ACE inhibitors or Angiotensin II receptor antagonists.
- •Patients with uncontrolled hypertension. Patients with uncontrolled hypertension, or a screening blood pressure greater than 140/90 for two consecutive weeks.
- •Patients unable to receive thromboprophylaxis.
- •Pregnant or lactating women at the screening visit.
- •Abnormal screening blood tests exceeding any of the limits defined below:
Outcomes
Primary Outcomes
Not specified
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