A safety and tolerability study of Pimavanserin in patients with Parkinson's Disease Psychosis

Phase 1

• Conditions: MedDRA version: 20.0Level: LLTClassification code 10037241Term: Psychosis NOSSystem Organ Class: 100000004873; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-003512-12-FR
• Lead Sponsor: ACADIA Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-30
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 8

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

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified