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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01006265 | Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800 in Patients With Relapsing-remitting Multiple Sclerosis | PHASE2 | COMPLETED | 464 | — | — | Oct 1, 2009 | Jul 1, 2011 | Mar 30, 2025 | 115 | United States, Australia +21 |
Cumulative Number of new T1 gadolinium-enhancing (Gd+) lesions per year on magnetic resonance imaging (MRI) scan from Week 12 to Week 24 were reported. Negative binomial (NB) regression analysis on Per protocol analysis set and imputation was applied for the missing data. Here, MS signifies multiple sclerosis.
| Arm | Type | Description |
|---|---|---|
| ACT-128800 Dose 1 | EXPERIMENTAL | ACT-128800 Dose 1 |
| ACT-128800 Dose 2 | EXPERIMENTAL | ACT-128800 Dose 2 |
| ACT-128800 Dose 3 | EXPERIMENTAL | ACT-128800 Dose 3 |
| Placebo | PLACEBO_COMPARATOR | Matching placebo |
| Name | Type | Description |
|---|---|---|
| ACT-128800 Dose 1 | DRUG | ACT-128800 (Dose 1) administered orally once daily |
| Placebo | DRUG | Matching placebo administered orally once daily |
| ACT-128800 Dose 2 | DRUG | ACT-128800 (Dose 2) administered orally once daily |
| ACT-128800 Dose 3 | DRUG | ACT-128800 (Dose 3) administered orally once daily |
Inclusion Criteria: * Adult males and females * Diagnosis of RRMS as defined by the revised (2005) McDonald Diagnostic Criteria for Multiple Sclerosis (MS). * Signed inform consent prior to initiation of any study-mandated procedure. Exclusion Criteria: * A diagnosis of MS categorized as primary ...