Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Pimavanserin tartrate, pimavanserin tartrate (ACP-103), Pimavanserin tartrate (ACP-103), pimavanserin tartrate
Pimavanserin · 19 trials · 11 indications
The NSA-16 is a semi-structured interview and a validated scale containing 16 items for evaluating negative symptoms of schizophrenia, i.e. the reduction or absence of emotional expression and volitional behaviors normally present in a healthy person. Items are scored based on behaviors during the interview (items 1-4, 6, 7, 9, 11, 15, 16) or previous 7 days (items 5, 8, 10, 12-14) on a 6-point scale from 1 to 6. The NSA-16 total score is the sum of item scores. It can range from 16 to a maximum of 96, with higher scores denoting more severe negative symptoms in schizophrenia.
The HAMD-17 consists of 8 items with a score on a 3 point scale and 9 items with a score on a 5 point scale. The total score ranging from 0 to 52 will be calculated as the sum of the scores for all 17 items. Higher total scores denote more severe depression.
Number (%) of patients experiencing at least one TEAE
The time from randomization to relapse in the DB period was compared between treatment groups using a Cox regression model. The treatment effect was measured by the hazard ratio (HR). Relapse was defined as (1) ≥30% increase in SAPS-H+D total score from DB baseline (BL) and CGI-I score ≥6 relative to DB BL, (2) treatment with antipsychotic for dementia-related delusions/hallucinations, (3) treatment/study discontinuation due to lack of efficacy, and/or (4) hospitalization for worsening dementia-related psychosis. SAPS-H+D is a 20-item scale; the total score is the sum of the 20 item scores (range 0-100); higher scores denote more severe symptoms. CGI-I is a clinician-rated 7-point scale to rate improvement in hallucinations/delusions relative to BL (range 1-7); higher scores denote less improvement or worsening. A pre-specified IA was conducted after accrual of 40 adjudicated relapse events. The prespecified stopping criterion was met; the study was stopped for efficacy.
The PANSS is a 30-item scale used to evaluate the presence, absence, and severity of schizophrenia symptoms. The 30 items are arranged as 7 positive symptom items (P1 to P7), 7 negative symptom items (N1 to N7), and 16 general psychopathology symptom items (G1 to G16). Items are scored over the past week (7 days) on a 7-point scale ranging from 1 (absent) to 7 (extreme). The PANSS total score can range from a minimum of 30 to a maximum of 210, where a higher score signifies greater severity of schizophrenia symptoms.
Antipsychotic Efficacy was defined as a decrease in the severity and/or frequency of hallucinations and/or delusions. This is measured as the change from baseline (Day 1) to Day 43 in the Scale for the Assessment of Positive Symptoms 9-item sum score for Parkinson's Disease (SAPS-PD). The possible total score is 0 to 45 and a negative change in score indicates improvement. Analysis Method: Mixed Model Repeated Measures (MMRM)
Number (%) of patients with drug-related treatment-emergent AEs (i.e. AEs reported by the Investigator as possibly, probably, or highly probably related to study drug)
Assessed using cognitive neuroscience task, comparison between pimavanserin and placebo within participants in single-dose cross-over experiment.
Assessed using the Repetitive Behavior Scale - Revised (RBS-R) rated at baseline, 3, and 6 weeks. The RBS-R is a 44-item self-report form used to measure the wide range of repetitive behavior in children, adolescents, and adults with Autism Spectrum disorders. The scale consists of six subscales with questions related to Stereotyped Behavior, Self-injurious Behavior, Compulsive Behavior, Routine Behavior, Sameness Behavior, and Restricted Behavior rated between 0 to 3 on severity of each item.
In the TAP, the subject competes against a fictitious opponent in a reaction time game during which the investigator manipulates provocation by having the "opponent" select increasing (mild) electric shock levels (i.e., a physically aggressive threat) which then elicits aggressive responding to the "confederate" when he/she loses a reaction-time task. Subjects can select shock from level 1 to level 9, and to select a "high" (10 level) or a "very high" (20 level) shock. The total number of "High" / "Very High" (10/20) shocks selected for the opponent is the outcome for heightened aggression in this study.
The Aberrant Behavior Checklist (ABC) is a caregiver-rated scale comprised of 5 empirically-derived subscales encompassing 58 items that describe various behavior problems. It measures domains of irritability, lethargy/social withdrawal, stereotypic behavior, hyperactivity/noncompliance, and inappropriate speech. ABC-I is one of the subscales and comprises of 15 items. Minimum score is 0, maximum is 45. A score for each item ranges from 0 indicating "not at all a problem" to 3 indicating "the problem is severe in degree". Subscale scores are calculated by summing the items within that subscale. Higher scores indicate greater impairment.
The HAMD-17 is a multiple-item questionnaire to assess the severity of depression, including items of mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. Each of the 17 items is scored on a 3- or 5-point scale (depending on the item). The minimum total score is 0; the maximum total score is 52. A higher total score signifies more severe depression.
Safety and tolerability of pimavanserin after 52 weeks of treatment in patients with probable Alzheimer's disease who have symptoms of agitation and Aggression, in terms of occurrence of TEAEs
The Hamilton Rating Scale for Depression (HAMD-17) is a 17-item scale to assess depression. The HAMD-17 consists of 8 items with a score on a 3 point scale and 9 items with a score on a 5 point scale. Each item is rated from least (0) to most frequent or most severe, as applicable, with highest scores of 2 to 4, depending on the item. Items are summed up to calculate the HAMD-17 total score. The total score ranges from 0 to 52. A higher total score indicates more severe depression.
The NSA-16 is a semi-structured interview and a validated scale containing 16 items for evaluating negative symptoms of schizophrenia, i.e. the reduction or absence of emotional expression and volitional behaviors normally present in a healthy person. Items are scored based on behaviors during the interview (items 1-4, 6, 7, 9, 11, 15, 16) or previous 7 days (items 5, 8, 10, 12-14) on a 6-point scale from 1 to 6. The NSA-16 total score is the sum of item scores. It can range from 16 to a maximum of 96, with higher scores denoting more severe negative symptoms in schizophrenia.
Number (%) of patients with drug-related treatment-emergent AEs
| Arm | Type | Description |
|---|---|---|
| Drug - Pimavanserin | EXPERIMENTAL | Pimavanserin 34 mg taken as two tablets + background antipsychotic, once daily by mouth |
| Placebo | PLACEBO_COMPARATOR | Placebo + background antipsychotic, taken as two tablets, once daily by mouth |
| Pimavanserin | EXPERIMENTAL | Drug- pimavanserin 34 mg, 20 mg, or 10 mg taken as two tablets + background antipsychotic, once daily by mouth |
| 1 | EXPERIMENTAL | pimavanserin tartrate, 40 mg, tablet, once daily by mouth for 6 weeks |
| 2 | PLACEBO_COMPARATOR | placebo, tablet, once daily by mouth for 6 weeks |
| Pimavanserin tartrate (ACP-103) | EXPERIMENTAL | Tablets taken once daily by mouth for as long as ACP-103 is considered to be tolerated and beneficial to subjects |
| 3 | EXPERIMENTAL | Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks |
| Pimavanserin tartrate | EXPERIMENTAL | Pimavanserin 34 mg white to off-white capsules. |
| Pimavanserin low dose | EXPERIMENTAL | Patients aged 5 to 12 years: 10 mg/day pimavanserin Patients aged 13 to 17 years: 20 mg/day pimavanserin Pimavanserin given once daily, as capsule of 10 or 20 mg dose strength, respectively, according to the patient's age |
| Pimavanserin high dose | EXPERIMENTAL | Patients aged 5 to 12 years: 20 mg/day pimavanserin Patients aged 13 to 17 years: 34 mg/day pimavanserin Pimavanserin given once daily, as capsule of 20 or 34 mg dose strength, respectively, according to the patient's age |
| Pimavanserin 20 mg OR 34 mg per day | EXPERIMENTAL | - |
| Pimavanserin 34 mg + SSRI/SNRI | EXPERIMENTAL | Drug- pimavanserin, 34 mg, taken as two 17 mg tablets, once daily by mouth All patients continued to receive selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) antidepressants at a stable dose for the duration of the study. |
| Placebo + SSRI/SNRI | PLACEBO_COMPARATOR | Placebo, taken as two tablets, once daily by mouth All patients continued to receive selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) antidepressants at a stable dose for the duration of the study. |
| Pimavanserin 40 mg | EXPERIMENTAL | Pimavanserin tartrate, 40 mg (two 20 mg tablets), once daily by mouth (equivalent to 34 mg free base pimavanserin) |
| Name | Type | Description |
|---|---|---|
| Pimavanserin | DRUG | Pimavanserin 34 mg, taken as two blinded 17 mg tablets once daily by mouth |
| Placebo | DRUG | Placebo, taken as two blinded tablets once daily by mouth |
| Pimavanserin 34 mg | DRUG | Pimavanserin 34 mg total daily dose, tablets, once daily by mouth |
| Pimavanserin 20 mg | DRUG | Pimavanserin 20 mg total daily dose, tablets, once daily by mouth |
| pimavanserin tartrate | DRUG | pimavanserin tartrate, 40 mg, tablet, once daily by mouth for 6 weeks |
| Pimavanserin tartrate (ACP-103) | DRUG | 10 mg, tablet, once daily by mouth, for six weeks |
| Pimavanserin Tartrate 34 Mg ORAL CAPSULE [NUPLAZID] | DRUG | Participants will be randomized to take a single dose of either pimavanserin 34 mg or placebo at Visit 2. |
Inclusion Criteria: * Male or female, ≥18 and ≤55 years of age at the time of Screening * Has a caregiver or some other identified responsible person (e.g., family member, social worker, caseworker, or nurse) considered reliable by the Investigator in providing support to the subject to help ensure...
Pimavanserin is a small molecule drug being developed by ACADIA Pharmaceuticals Inc. (ACAD). It is an inverse agonist of the HTR2A receptor and is under investigation for several psychiatric and neurological conditions, including major depressive disorder, Alzheimer's disease psychosis, and autism spectrum disorder.
Pimavanserin is being studied for multiple indications, including adjunctive treatment of major depressive disorder, agitation and aggression in Alzheimer's disease, Alzheimer's disease psychosis, autism spectrum disorder, dementia-related psychosis, and intermittent explosive disorder. It is not yet approved for these uses.
Pimavanserin targets the HTR2A receptor, also known as the serotonin 2A receptor. It acts as an inverse agonist at this receptor, meaning it blocks the receptor's activity. This mechanism is being explored for treating various psychiatric symptoms.
Pimavanserin is being developed by ACADIA Pharmaceuticals Inc., which trades on the NASDAQ under the ticker ACAD. ACADIA is the sponsor of the clinical trials investigating pimavanserin for multiple indications.
Pimavanserin is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA for the indications currently being studied. The Phase 3 program includes a completed trial in negative symptoms of schizophrenia.
Pimavanserin has been studied in several clinical trials, including NCT05999240 for autism spectrum disorder, NCT05895513 for intermittent explosive disorder, NCT05523895 for irritability associated with autism spectrum disorder, and NCT04531982 for negative symptoms of schizophrenia. These trials include both Phase 2 and Phase 3 studies.
Yes, pimavanserin tartrate is the tartrate salt form of pimavanserin. Other names include ACP-103 and Nuplazid. The drug is also referred to as pimavanserin 34 mg or pimavanserin tartrate 34 mg oral capsule.