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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03623321 | Extension Study of Pimavanserin in Adult Subjects With Neuropsychiatric Symptoms Related to Neurodegenerative Disease | PHASE3 | COMPLETED | 595 | — | — | Jul 17, 2018 | May 5, 2023 | Dec 20, 2024 | 88 | United States, Bulgaria +10 |
| NCT03575052 | A Safety Study of Pimavanserin in Adult and Elderly Subjects Experiencing Neuropsychiatric Symptoms Related to Neurodegenerative Disease | PHASE3 | COMPLETED | 784 | — | — | May 21, 2018 | May 6, 2022 | Dec 31, 2024 | 104 | United States, Bulgaria +10 |
Number (%) of patients experiencing at least one TEAE
| Arm | Type | Description |
|---|---|---|
| Drug - pimavanserin | EXPERIMENTAL | Pimavanserin 34 mg is provided as 2×17 mg tablets as single dose, once daily by mouth. Dose adjustments of pimavanserin down to 20 mg (provided as 2×10 mg tablets as a single dose, once daily by mouth) and up to 34 mg are permitted based on Investigator assessment of clinical response. |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Pimavanserin | DRUG | • Pimavanserin 34 mg is provided as 2×17 mg tablets as single dose, once daily by mouth. Dose adjustments of pimavanserin down to 20 mg (provided as 2×10 mg tablets as a single dose, once daily by mouth) and up to 34 mg are permitted based on Investigator assessment of clinical response. |
| Placebo | DRUG | Placebo, tablets, once daily by mouth (provided as two placebo tablets) |
Inclusion Criteria: 1. Subject satisfied all entry criteria for the antecedent pimavanserin study 2. Subject completed the antecedent study; or was participating in a pimavanserin study that the Sponsor ended early 3. Has a designated study partner/caregiver who meets the following requirements: ...