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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00811902 | Efficacy, Safety, and Tolerability of Nerispirdine in Patients With Multiple Sclerosis | PHASE2 | COMPLETED | 405 | — | — | Dec 1, 2008 | Mar 1, 2010 | Feb 26, 2016 | 7 | United States, Canada +5 |
| NCT00772525 | Single Oral Doses Study of Nerispirdine on Visual Function in Patients With Multiple Sclerosis | PHASE2 | COMPLETED | 31 | — | — | Sep 1, 2008 | Jun 1, 2009 | Feb 26, 2016 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Nerispirdine 50mg | EXPERIMENTAL | Nerispirdine 50mg once daily for 14 weeks |
| Nerispirdine 100mg | EXPERIMENTAL | Nerispirdine 100mg once daily for 14 weeks |
| Nerispirdine 200mg | EXPERIMENTAL | Nerispirdine 200mg once daily for 14 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo for Nerispirdine once daily for 14 weeks |
| Sequence 1 | EXPERIMENTAL | placebo,1 day treatment period 1 50 mg Nerispirdine, 1 day treatment period 2 400 mg Nerispirdine, 1 day treatment period 3 |
| Sequence 2 | EXPERIMENTAL | placebo,1 day treatment period 1 400 mg Nerispirdine, 1 day treatment period 2 50 mg Nerispirdine, 1 day treatment period 3 |
| Sequence 3 | EXPERIMENTAL | 50 mg Nerispirdine, 1 day treatment period 1 placebo, 1 day treatment period 2 400 mg Nerispirdine, 1 day treatment period 3 |
| Sequence 4 | EXPERIMENTAL | 50 mg Nerispirdine, 1 day treatment period 1 400 mg Nerispirdine, 1 day treatment period 2 placebo, 1 day treatment period 3 |
| Sequence 5 | EXPERIMENTAL | 400 mg Nerispirdine, 1 day treatment period 1 placebo, 1 day treatment period 2 50 mg Nerispirdine, 1 day treatment period 3 |
| Sequence 6 | EXPERIMENTAL | 400 mg Nerispirdine, 1 day treatment period 1 50 mg Nerispirdine, 1 day treatment period 2 placebo, 1 day treatment period 3 |
| Name | Type | Description |
|---|---|---|
| Nerispirdine | DRUG | tablet, oral administration |
| placebo | DRUG | tablet, oral administration |
Inclusion Criteria: * Clinically definite MS (according to McDonald criteria), Exclusion Criteria: * Multiple sclerosis exacerbation or clinical relapse within 6-month prior to the screening visit. * Subject who is not able to complete two trials of a timed 25 foot walk, with or without an assist...