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

Conditions: Primary progressive multiple sclerosis
MedDRA version: 9.1Level: LLTClassification code 10063401Term: Primary progressive multiple sclerosis

Registration Number: EUCTR2008-005125-11-GB

Lead Sponsor: Walton Centre for Neurology and Neurosurgery

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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:
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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the size of the effect, if any, of recombinant human erythropoietin (rhEPO) in improving symptoms of primary progressive multiple sclerosis (PPMS), as measured by Maximum Walking Distance, Multiple Sclerosis Functional Composite (MSFC), Expanded Disability Status Scale (EDSS), Multiple Sclerosis Impact Scale 29 (MSIS), and Neurological Fatigue Index (NFI).;Secondary Objective: Provide data to allow sample size calculations for a larger multi-centre study for the primary outcome MSFC <br>Identify any barriers to patient recruitment<br>Provide information about withdrawals and loss to follow up in this population<br>Determine suitability of timing of follow up appointments and methods used to collect questionnaires (MSIS, NFI).<br>;Primary end point(s): Change in Maximum walking distance from baseline to last visit. <br>Change in EDSS from baseline to last visit.<br>

Secondary Outcome Measures