E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Only those patients that have completed the Phase1 of the trial( no study drug) will be recruited |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Information not present in EudraCT |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |