Multiple Sclerosis
Conditions
Interventions
Trade Name: Amiloride
Product Name: Amiloride Hydrochloride
Pharmaceutical Form: Coated tablet
Sponsors
Oxford Racliffe NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects with primary progressive MS, who have completed the Phase I of the study which was performed over 52 weeks, when patients were not given any specific treatment. 2. Willing and able to comply with study visits according to protocol for the full study period 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) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 11. Any immunosuppressive or immunomodulatory therapy received in the previous 12 months of the study. 2. Corticosteroids ( excluding topical or inhaled steroids) received in the previous three months. 3. Hyperkalemia i.e; serum potassium levels ( greater than 5.5 mEq per litre) 4. Patients on potassium supplementation, patients receiving other potassium-conserving agents, such as spironolactone or triamterene. Potassium supplementation in the form of medication, potassium-containing salt substitutes or a potassium-rich diet. 5. Impaired renal function : Anuria, acute or chronic renal insufficiency and evidence of diabetic nephropathy 6. Diabetes mellitus. 7. Hypersensitivity to amiloride hydrochloride or its ingredients. 8. Other serious illnesses or medical conditions such as cardiopulmonary disease. 9. Patient on angiotensin II receptor antagonist, angiotensin receptor blocker, cyclosporine and tacrolimus. 10. Pregnant or breast feeding women, or patient/partner planning pregnancy within next 12months. 11. Blood urea nitrogen [BUN] levels over 30 mg per 100 mL or serum creatinine levels over 1.5 mg per 100 mL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The prinicipal aim of this study is to assess the efficacy of Amiloride on neurodegenerative change in multiple sclerosis.The primary outcome measure will be change in Magnetic resonance imaging markers studied over a period of 12 months.;Secondary Objective: The secondary research objective will be to assess Physician based EDSS and patient based MSIS-29. The overall mean change from baseline to end of study will be assessed.;Primary end point(s): MRI evidence of slowing of progression. However the study will terminate at 52 weeks after patients have been started on study drug | — |
Countries
United Kingdom
Outcome results
None listed