MedDRA version: 20.0 Level: LLT Classification code 10037241 Term: Psychosis NOS System Organ Class: 100000004873
Conditions
Interventions
Product Name: Pimavanserin
Product Code: pimavanserin (ACP-103)
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Pimavanserin tartrate
CAS Number: 706782-28-7
Current Sponsor code: pimavan
Sponsors
ACADIA Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patient is participating in the ACP-103-015 study, and may, in the opinion of the Investigator, benefit from continued therapy with pimavanserin. 2. Patient is willing and able to provide informed consent. If the patient is unable to provide written consent, consent must be given by a legally authorized representative (LAR). 3. Female patients must be of non-childbearing potential (defined as either surgically sterilized or at least 1 year post-menopausal) or must agree to use a highly effective method of contraception (such as intrauterine device, diaphragm, or oral, or injectable [e.g., Depo-Provera] or implantable contraception [e.g., Norplant® System]) during the study and 1 month following completion of the study. 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 1 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 7
Exclusion criteria
Exclusion criteria: 1. Patient has current evidence of a clinically significant concurrent medical illness including: severe cardiac disease (recent myocardial infarction, congestive heart failure or cardiac syncope), severe pulmonary disease (chronic obstructive pulmonary disease or emphysema), renal insufficiency or failure, hepatitis, a recent diagnosis of malignancy (excluding basal or squamous cell carcinoma), a serious or unstable gastrointestinal, hematologic, or other medical disorder, which in the opinion of the Investigator, may prevent them from participating in the study. 2. Use of any of the medications prohibited or restricted as described in Section 5.3.1 and Appendix 2 of the Protocol. 3. Use of medications known to prolong the QT interval (as described in Appendix 2). 4. Electrocardiogram (ECG) with Fridericia corrected QT interval (QTcF) of >460 msec. 5. Clinically significant laboratory abnormalities that in the judgment of the Investigator would jeopardize the safe conduct of the study. 6. Pregnant or breastfeeding patients. Female patients of child-bearing potential must have a negative pregnancy test at Baseline confirmed using a dipstick urine pregnancy test. 7. Likely to have an allergy or sensitivity to pimavanserin based on known allergies to drugs of the same class. 8. Has any condition that would interfere with the ability to comply with the study instructions or might confound the interpretation of the study results or put the subject at undue risk (in the opinion of the investigator).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to explore the safety and tolerability of pimavanserin in patients with PDP.;Secondary Objective: • To explore the safety and tolerability of continued pimavanserin treatment in patients with PDP who have previously received long-term pimavanserin treatment for their symptoms. • To explore the efficacy of continued pimavanserin treatment in patients with PDP who have previously received long-term pimavanserin treatment for their symptoms.;Primary end point(s): No statistical analyses will be performed for this study. Data will be reported in listings for each patient and in narratives for SAEs/deaths.;Timepoint(s) of evaluation of this end point: Not Applicable | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not Applicable;Timepoint(s) of evaluation of this end point: Not Applicable | — |
Countries
France, Portugal, Russian Federation, Serbia
Contacts
Public ContactLewis Gryziewicz
ACADIA Pharmaceuticals Inc.
Outcome results
None listed