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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01665144 | Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND) | PHASE3 | COMPLETED | 1,651 | — | — | Dec 20, 2012 | Mar 31, 2023 | Jun 5, 2024 | 290 | United States, Argentina +29 |
The EDSS uses an ordinal scale to assess neurologic impairment in MS based on a neurological examination. Scores in each of 7 functional systems (Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel \& Bladder, and Cerebral) and an ambulation score were combined to determine the EDSS steps, ranging from 0 (normal) to 10 (death due to MS). 3-month confirmed disability progression is defined as an increase of score of 1 point in patients with baseline score of 3.0 to 5.0 and 0.5 point increase with baseline score of 5.5 to 6.5 sustained for at least 3 months.
| Arm | Type | Description |
|---|---|---|
| Siponimod (BAF312) | EXPERIMENTAL | Participants started on Day 1 and were uptitrated from 0.25 mg to 2 mg of BAF312 orally over a period of 6 days. After Day 7, participants continued on the treatment epoch for 3 months. During the Core Part of the study, participants participated in a maximum of 3 epochs. Following the Core Part, eligible patients enter the Extension Part during which all receive open-label BAF312. |
| Placebo | PLACEBO_COMPARATOR | Matching placebo to BAF312 was administered orally during the Core Part of the trial. Following the Core Part, eligible participants enter the Extension Part during which all receive open-label BAF312. |
| Name | Type | Description |
|---|---|---|
| BAF312 | DRUG | 0.25, 0.5, 1, and 2 mg film-coated tablets |
| Placebo | DRUG | Film-coated tablets |
Inclusion Criteria: * Prior history of relapsing remitting MS * SPMS defined as progressive increase of disability over at least 6 months * EDSS score of 3.0 to 6.5 * No relapse of corticosteroid treatment within 3 months Exclusion Criteria: * Women of child bearing potential must use reliable fo...