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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01753076 | Study of Ozanezumab (GSK1223249) Versus Placebo in the Treatment of Amyotrophic Lateral Sclerosis | PHASE2 | COMPLETED | 304 | — | — | Dec 20, 2012 | Jan 22, 2015 | Dec 21, 2017 | 35 | United States, Australia +9 |
The joint rank score is a combined assessment of function and survival. Function is assessed using change from Baseline in the ALSFRS-R total score. To calculate joint rank scores, every participant was compared with all other participants in a pair wise manner and assigned a score of -1, 0 or 1 based on their relative outcomes. A subject's joint rank score is the sum of their scores across the pair wise comparisons. The . The ALSFRS-R was a quickly administered (5 min) ordinal rating scale used to determine a participant's assessment of their capability and independence in 12 functional activities. There were 12 questions, graded by the participant 0-4 (4 is normal). Score of 0 (worst) to 48 (best). Reflects speech and swallowing, fine motor skills, large motor skills, and breathing. Lower scores of ALSFRS-R reflect greater impairment.
| Arm | Type | Description |
|---|---|---|
| Ozanezumab IV | EXPERIMENTAL | Administered by IV route. Treatment period - 48 Weeks |
| Placebo | PLACEBO_COMPARATOR | Normal saline by IV route. Treatment period - 48 weeks |
| Name | Type | Description |
|---|---|---|
| Ozanezumab | DRUG | Ozanezumab injection solution |
| Placebo | DRUG | Normal saline (0.9% sodium chloride) infusion |
Inclusion Criteria: * Patients with diagnosis of familial or sporadic ALS * Onset of muscle weakness no more than 30 months before screening visit. * Slow Vital Capacity (SVC) of at least 65% predicted for gender, age, ethnicity and height at Screening. * If on riluzole, the dose must have been sta...