Primary progressive multiple sclerosis MedDRA version: 9.1 Level: LLT Classification code 10063401 Term: Primary progressive multiple sclerosis
Conditions
Interventions
Trade Name: Neorecormon
Product Name: Recombinant Human Erythropoietin
Product Code: rhEPO
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: epoetin beta
CAS Numb
Sponsors
Walton Centre for Neurology and Neurosurgery
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Identify any barriers to patient recruitment Provide information about withdrawals and loss to follow up in this population Determine suitability of timing of follow up appointments and methods used to collect questionnaires (MSIS, NFI). ;Primary end point(s): Change in Maximum walking distance from baseline to last visit. Change in EDSS from baseline to last visit. | — |
Countries
United Kingdom
Outcome results
None listed