A pilot single-centre randomised controlled trial of recombinant human erythropoietin versus placebo in primary progressive multiple sclerosis.

Walton Centre for Neurology and Neurosurgery0 个研究点开始时间: 2009年1月7日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•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

•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:
•Platelets < 80 X109/L
•Baseline neutrophil counts of less than 1.5 X109/L
•Total white blood cell count less than 2.3 X109/L
•Creatinine 60 – 110 µmol/L
•Female patients, unless postmenopausal (2 years or more) or surgically sterile, who are unwilling to practice effective contraception during the study. The rhythm method is not to be used as the sole method of contraception.
•Male patients and their partners who are unwilling to practice effective contraception during the study.
•Women considering becoming pregnant while on study.

发起方

Walton Centre for Neurology and Neurosurgery