Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD3241 · 5 trials · 4 indications
Striatum Brain region: Change from baseline in microglia activation via PET By \[11C\]PBR28 binding to translocator protein
Vital signs: systolic and diastolic blood pressure and pulse including orthostatic challenge will be assessed. Change from baseline at each visit will be calculated as the visit value minus the baseline value for each vital sign: Blood Pressure, pulse rate (supine and standing), weight and oral temperature.
Assessment of general appearance, skin, head and neck, lymph nodes, thyroid, abdomen, cardiovascular, respiratory, and neurological systems, including full palpation of thyroid gland.
Suicidality as assessed by the Columbia-Suicide Severity Rating Scale (CSSRS) The CSSRS assesses the suicidal behavior and suicidal ideation in patients. Occurrence of suicidal behavior is defined as having answered "yes" to a least 1 of the 4 suicidal behavior sub categories (actual attempt, interrupted attempt, aborted attempt, and preparatory acts or behavior) at any post randomization evaluation. Occurrence of suicidal ideation after randomization is defined as having answered "yes" to at least one of the suicidal ideation sub-categories (wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods \[not plan\] without intent to act, active suicidal ideation with some intent to act \[without specific plan\], and active suicidal ideation with specific plan and intent) at any post randomization evaluation.
Change from baseline at each visit will be calculated as the visit value minus the baseline value for each continuous clinical chemistry, hematology and urinalysis measurements. Abnormal or out-of-range values will be flagged.
Change from baseline at each visit will be calculated as the visit value minus the baseline value for each ECG parameter: heart rate, QRS duration, PR interval, RR interval, QT and calculated QTcF interval. Abnormal or out-of-range values will be flagged.
| 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. |
| AZD3241, 300 mg | ACTIVE_COMPARATOR | AZD3241 300 mg BID |
| AZD3241, 600 mg | ACTIVE_COMPARATOR | AZD3241 600 mg BID |
| Placebo | PLACEBO_COMPARATOR | Placebo to AZD3241 |
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| 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. |
| AZD3241 300 mg BID | DRUG | The following dose escalation schedule will be used for 300 mg BID: 100 mg BID from Day 1 through Day 7. On Day 8, the patients will start maintenance treatment of 300 mg BID for the duration of the treatment period. |
| AZD3241 600 mg BID | DRUG | The following dose escalation schedule will be used for 600 mg BID: 100 mg BID from Day 1 through Day 7 and 300 mg BID from Day 8 through Day 14. On Day 15, the patients will start maintenance treatment of 600 mg BID for the duration of the treatment period. |
| ER tablet 25 mg AZD3241 | DRUG | 2 tablets twice daily for Day 1 |
| ER tablet 100 mg AZD3241 | DRUG | 1-6 tablets twice daily from Day 2 until Day 56±3 days |
| Placebo for AZD3241 25 mg | DRUG | 2 tablets twice daily for Day 1 |
| Placebo for AZD3241 100 mg | DRUG | 1-6 tablets twice daily from Day 2 until Day 56±3 days |
| Placebo Tablet | DRUG | Oral Tablet. Repeated Administration |
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...
AZD3241 is an investigational small molecule being studied in Parkinson's Disease, Multiple System Atrophy (MSA), and in healthy volunteers. It has been evaluated in clinical trials for these conditions, though it remains in clinical development and is not approved.
AZD3241 is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company has sponsored clinical trials of the drug in Parkinson's Disease and Multiple System Atrophy.
AZD3241 has completed Phase 1 and Phase 2 clinical trials. It is an investigational drug still in clinical development, with no approved status. Trials have been completed in healthy volunteers, Parkinson's Disease, and Multiple System Atrophy.
AZD3241 has been studied in several completed trials, including NCT00729443 in healthy volunteers, NCT01527695 and NCT01603069 in Parkinson's Disease, and NCT02388295 in Multiple System Atrophy. All trials are completed, with no active trials ongoing.
AZD3241 is the primary name used in clinical trials and publications. No alternative names have been reported for this drug in the available data.