A safety and tolerability study of ACP-103 in patients with Parkinson's Disease Psychosis

• Register: EUCTR
• Last refreshed on: 28 February 2019
• Main ID: EUCTR2007-003035-22-GB
• Date of registration: 20/12/2007
• Prospective Registration: Yes
• Primary sponsor: ACADIA Pharmaceuticals Inc.
• Public title: A safety and tolerability study of ACP-103 in patients with Parkinson's Disease Psychosis
• Scientific title: A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease - ACP-103-015
• Date of first enrolment: 05/11/2008
• Target sample size: 400
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-003035-22
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Belgium, Canada, European Union, France, India, Italy, Portugal, Russian Federation, Sweden, Ukraine, United Kingdom, United States

Contacts

• Name: Lewis Gryziewicz
• Affiliation: Acadia Pharmaceuticals Inc.

• Name: Lewis Gryziewicz
• Affiliation: Acadia Pharmaceuticals Inc.

Key inclusion & exclusion criteria

Inclusion criteria:
1. Subject has completed the blinded treatment period of a previous study of pimavanserin in PDP within the last 28 days and, who may, in the opinion of the Investigator, benefit from therapy with pimavanserin
2. Subject must have clear sensorium at study entry (i.e., oriented to time, person, and place) and thus not be delirious
3. Female subjects must be of non-childbearing potential (defined as either surgically sterilized or at least 1 year post-menopausal) or must agree to use a clinically acceptable method of contraception (such as intrauterine device [IUD], diaphragm, or oral, injectable [e.g. Depo-Provera] or implantable contraception [e.g. Norplant? System]) during the study and one month following completion of the study
4. The subject is willing and able to provide consent
5. Caregiver is willing and able to provide consent and agrees to accompany the subject to all visits

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 350

Exclusion criteria:
1. Subject 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 and or unstable gastrointestinal, hematologic or other medical disorder
2. Subject is using any of the medications prohibited or restricted as described in Appendix 1 (Prohibited and Restricted Concomitant Medications
3. Subject is on medications known to prolong the QT interval (as described in Appendix 1)
4. Subject has a baseline electrocardiogram (ECG) with Bazett’s corrected QT (QTcB) of greater than 460 msec if male or 470 msec if female
5. Subject had an allergy or sensitivity to pimavanserin based on known allergies to drugs of the same class
6. Subject is judged by the Investigator to be inappropriate for the study



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Psychosis in Parkinson's Disease
MedDRA version: 20.0 Level: LLT Classification code 10037241 Term: Psychosis NOS System Organ Class: 100000004873

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Product Name: Pimavanserin tartrate
Product Code: pimavanserin (ACP-103)
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Pimavanserin tartrate
CAS Number: 706782-28-7
Current Sponsor code: pimavanserin (ACP-103)
Other descriptive name: N/a
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-

Primary Outcome(s)

Secondary Objective: Not applicable

Primary end point(s): Safety:
• The safety of subjects will be assessed by monitoring adverse events, physical examinations, vital signs, clinical laboratory tests (hematology, clinical chemistry, and urinalysis) and ECGs.

Timepoint(s) of evaluation of this end point: Baseline, Week 2, Month 1, Month 3, Month 6, Month 9, Month 12 and
every 6 months thereafter

Main Objective: To assess long-term safety and tolerability of pimavanserin in subjects with Parkinson’s Disease Psychosis (PDP)

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Not Applicable

Secondary end point(s): Not Applicable

Secondary ID(s)

N/a

ACP-103-015

NCT00550238

Source(s) of Monetary Support

ACADIA Pharmaceuticals Inc.

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 14/06/2019
• Date Completed: 30/05/2018
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2007-003035-22/results