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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02388295 | AZD3241 PET MSA Trial, Phase 2, Randomized,12 Week Safety and Tolerability Trial With PET in MSA Patients | PHASE2 | COMPLETED | 59 | — | — | Apr 27, 2015 | Sep 19, 2016 | Sep 25, 2017 | 17 | United States, Austria +5 |
Striatum Brain region: Change from baseline in microglia activation via PET By \[11C\]PBR28 binding to translocator protein
| Arm | Type | Description |
|---|---|---|
| AZD3241 | EXPERIMENTAL | Subjects will be randomized to one of the two doses of AZD3241 or placebo in a 1:1:1 ratio. |
| Placebo to match AZD3241 | PLACEBO_COMPARATOR | Subjects will be randomized to one of the two doses of AZD3241 or placebo in a 1:1:1 ratio. |
| Name | Type | Description |
|---|---|---|
| AZD3241 | DRUG | Drug: AZD3241 administered for 12 weeks orally as a tablet. |
| Placebo | DRUG | Placebo to match AZD3241 administered for 12 weeks orally as a tablet. |
Inclusion Criteria: 1. Male or female, age 30-80 years, inclusive, at screen. 2. Meet criteria for diagnosis of probable or possible MSA according to the consensus criteria (Gilman et al. 2008 ). 3. "High-affinity binder" or "mixed-affinity binder" for TSPO, as confirmed by prospective genotyping o...