Neuropsychiatric Symptoms Related to Neurodegenerative Disease MedDRA version: 20.0 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: Pimavanserin 10mg
Product Code: ACP-103
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Pimavanserin
CAS Number: 706782-28-7
Current Sponsor code: pimavanserin ACP-103
Other
Sponsors
ACADIA Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject satisfied all entry criteria for the antecedent pimavanserin study 2. The subject may benefit from longer term therapy with open-label pimavanserin treatment in the judgment of the Investigator 3. Subject completed the antecedent study; or was participating in a pimavanserin study that the Sponsor ended early 4. Has a designated study partner/caregiver who meets the following requirements: a. In the Investigator’s opinion, is in contact with the subject frequently enough to accurately report on the subject’s symptoms and whether or not the subject is taking the study drug. Subjects with moderate or severe dementia, as evaluated by the Investigator, must live with a responsible adult who can provide direct supervision and monitoring of study medication administration. Subjects with mild dementia, as evaluated by the Investigator, must have close monitoring of study drug administration. b. In the Investigator’s opinion, is considered reliable in providing support to the subject to help ensure compliance with study treatment, study visits, and protocol procedures c. Is fluent in the local language in which study assessments will be administered d. Agrees to participate in study assessments, has the capacity to provide informed consent, and provides written consent to participate in the study 5. Subject can come to the clinic for study visits with a study partner/caregiver 6. Subject is willing and able to provide informed consent. Consent for the present study must be obtained prior to the final procedures being performed at antecedent study’s EOT visit or ET visit (if the study was ended early by the Sponsor). If the subject is deemed not competent to provide informed consent, the following requirements for consent must be met: a. The subject’s legally acceptable representative (LAR) (or study partner/caregiver, if local regulations allow) must provide written informed consent b. The subject must provide written (if capable) informed assent 7. If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing potential (defined as either surgically sterilized or at least 1 year postmenopausal) or must agree to use a clinically acceptable method of contraception or be abstinent during the study and 1 month following completion of the study. Abstinence as a method of contraception is defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. This option is usually made for a specific moral, religious, legal, or health reason. If heterosexual intercourse does occur, an acceptable method of birth control is required. Acceptable methods of birth control include the following: a. Condom, diaphragm, or cervical cap with spermicide b. Hormonal contraception, including oral, injectable, transdermal, or implantable methods c. Intrauterine device (IUD) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 75 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 675
Exclusion criteria
Exclusion criteria: 1. Subject is judged by the Investigator or the Medical Monitor to be inappropriate for the study, due to AEs, medical condition, or noncompliance with investigational product or study procedures in the antecedent study, or is judged to be a danger to self or others 2. Is in hospice, is receiving end-of-life palliative care, or has become bedridden 3. Has any of the following ECG results at the EOT/ET visit of the antecedent study: a. If the subject is not on citalopram, escitalopram, or venlafaxine: i. QTcF >450 ms, if QRS duration 470 ms, if QRS duration =120 ms b. If the subject is on citalopram, escitalopram, or venlafaxine: i. QTcF >425 ms, if QRS duration 450 ms, if QRS duration =120 ms 4. Has a heart rate 100 beats per minute, and/or a blood pressure of >165 mmHg (systolic) or >95 mmHg (diastolic) 5. Has a body mass index (BMI) <18.5 kg/m2 or known unintentional clinically significant weight loss (i.e., =7% of body weight) over past 6 months 6. Has clinically significant laboratory abnormalities in the antecedent study that, in the judgment of the Investigator or Medical Monitor, would either: a. jeopardize the safe participation of the subject in the study; OR b. would interfere with the conduct or interpretation of safety or efficacy evaluations in the study 7. Is suicidal as defined below at Visit 1 (Baseline) of the ACP-103-047 study: a. If the subject was assessed in the antecedent study using the Columbia-Suicide Severity Rating Scale (C-SSRS), he or she must not be actively suicidal at Visit 1 (Baseline) (including an answer of “yes” to C-SSRS questions 4 or 5) and must not have attempted suicide (using the “Since Last Visit” version) prior to Visit 1 (Baseline) of the present study; OR b. If the subject is not able to reliably complete the C-SSRS in the Investigator’s judgment or if the Global Clinician Assessment of Suicidality (GCAS) scale was used in the antecedent study, the subject must not be suicidal as assessed by the GCAS score (i.e., a score of 3 or 4) based on Investigator’s assessment of behavior since-last-visit at Visit 1 (Baseline); OR c. The subject is actively suicidal in the Investigator’s judgment 8. Has developed a neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical or mental disorder, including cancer or malignancies that, in the judgment of the Investigator, would increase the risk associated with taking study medication or significantly interfere with the conduct or interpretation of the study 9. Requires treatment with a medication or other substance that is prohibited by the protocol 10. Has a significant sensitivity or allergic reaction to pimavanserin or its excipients 11. Is an employee of ACADIA, or has a family member who is an employee of ACADIA
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of long-term pimavanserin treatment in adult and elderly subjects with neuropsychiatric symptoms related to neurodegenerative disease;Secondary Objective: To explore the safety and tolerability of long-term pimavanserin treatment in adult and elderly subjects with neuropsychiatric symptoms related to neurodegenerative disease on the following: - suicidality - cognition - extrapyramidal symptoms To explore the benefit of long-term pimavanserin treatment in adult and elderly subjects with neuropsychiatric symptoms related to neurodegenerative disease on: - clinical global impression of neuropsychiatric symptoms - quality of life - sleep;Primary end point(s): Treatment emergent adverse events (TEAEs);Timepoint(s) of evaluation of this end point: After final Database lock | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety and tolerability are described by: - Columbia-Suicide Severity Rating Scale (C-SSRS) score or Global Clinician Assessment of Suicidality (GCAS) scale (if the subject is not able to complete the C-SSRS in the Investigator’s judgment) - Mini-Mental State Examination (MMSE) - Extrapyramidal Symptom Rating Scale A (ESRS-A) ;Timepoint(s) of evaluation of this end point: After final Database lock | — |
Countries
Bulgaria, Colombia, Czechia, Czech Republic, Georgia, Mexico, Poland, Romania, Russian Federation, Serbia, South Africa, Ukraine, United States
Contacts
Public ContactRegulatory Affairs (Teresa Brandt)
ACADIA Pharmaceuticals Inc.
Outcome results
None listed