Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01910259 | MS-SMART: Multiple Sclerosis-Secondary Progressive Multi-Arm Randomisation Trial | PHASE2 | COMPLETED | 445 | — | — | Dec 18, 2014 | Jul 4, 2018 | Mar 26, 2020 | 13 | United Kingdom |
To establish whether a drug, from a panel of 3 leading candidate neuroprotective drugs, slows the rate of brain volume loss in SPMS over 96 weeks using MRI-derived percentage brain volume change (PBVC).
| Arm | Type | Description |
|---|---|---|
| Amiloride | EXPERIMENTAL | Amiloride 5 mg twice per day (5 mg once per day for first 4 weeks) for 96 weeks |
| Riluzole | EXPERIMENTAL | Riluzole 50 mg twice per day (50 mg once per day for first 4 weeks) for 96 weeks |
| Fluoxetine | EXPERIMENTAL | Fluoxetine 20 mg twice per day (20 mg once per day for first 4 weeks) for 96 weeks |
| Placebo | PLACEBO_COMPARATOR | Matched placebo 1 capsule twice per day (1 capsule a day for first 4 weeks) for 96 weeks |
| Name | Type | Description |
|---|---|---|
| Amiloride | DRUG | Comparison with placebo |
| Riluzole | DRUG | Comparison with placebo |
| Fluoxetine | DRUG | Comparison with placebo |
| Placebo | DRUG | Placebo comparator |
Inclusion Criteria: * Confirmed diagnosis of SPMS. Steady progression rather than relapse must be the major cause of increasing disability in the preceding 2 years. Evidence of progression, either an increase of at least one point in EDSS or clinical documentation of increasing disability in patien...