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

• Register: EUCTR
• Last refreshed on: 6 November 2018
• Main ID: EUCTR2007-003035-22-AT
• Date of registration: 26/05/2008
• Prospective Registration: Yes
• Primary sponsor: Acadia Pharmaceuticals Inc
• Public 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
• 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
• Date of first enrolment: 30/03/2009
• Target sample size: 560
• 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: no 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
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Belgium, France, Italy, Portugal, Sweden, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. Subject has completed the treatment period of Study ACP-103-012 or Study ACP-103-014 within the last 28 days and, who may, in the opinion of the Investigator, benefit from continued therapy with ACP-103
2. Subject that has received stereotaxic surgery for subthalamic nucleus deep brain stimulation must be at least 6 months post surgery and the stimulator settings must have been stable for at least 1 month prior to Study Day 1 (Baseline) and must remain stable during the trial
3. Subject must have clear sensorium at study entry (i.e., oriented to time, person, and place) and thus not be delirious
4. 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
5. The subject is willing and able to provide consent
6. 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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 has received previous ablative stereotaxic surgery (i.e., pallidotomy and thalamotomy) to treat Parkinson’s disease (PD)
3. Subject is using any of the medications prohibited or restricted as described in Appendix 1 (Prohibited and Restricted Concomitant Medications
4. Subject is on medications known to prolong the QT interval (as described in Appendix 1)
5. Subject has a baseline electrocardiogram (ECG) with Bazett’s corrected QT (QTcB) of greater than 460 msec if male or 470 msec if female
6. Subject had an allergy or sensitivity to ACP-103 based on known allergies to drugs of the same class
7. 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: 9.1 Level: LLT Classification code 10037241 Term: Psychosis NOS

Intervention(s)

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

Primary Outcome(s)

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.

Secondary Objective:

Main Objective: To assess long-term safety and tolerability of ACP-103 in subjects with Parkinson’s Disease Psychosis (PDP)

Secondary ID(s)

2007-003035-22-GB

ACP-103-015