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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03567057 | A Safety and Efficacy Study of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment | PHASE3 | COMPLETED | 424 | — | — | Jul 18, 2018 | Apr 18, 2021 | Jan 18, 2022 | 92 | United States, Canada |
The incidence of treatment-emergent adverse events was used as the measure for long-term safety and tolerability of ADS-5102.
| Arm | Type | Description |
|---|---|---|
| ADS-5102, 274 mg | EXPERIMENTAL | 274 mg ADS-5102, administered once daily at bedtime for up to 52 weeks |
| Name | Type | Description |
|---|---|---|
| ADS-5102, 274 mg | DRUG | Oral capsules |
Inclusion Criteria: * Signed a current IRB-approved informed consent form * Successful completion of a prior double blind study of ADS-5102 in patients with MS walking impairment. Exclusion Criteria: * Based on the judgment of the investigator or Medical Monitor, participation in the study would ...