Ensayo multicéntrico, doble ciego y controlado con placebo para evaluar la seguridad y la eficacia de ACP-103 en el tratamiento de la psicosis en la enfermedad de Parkinson. A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease

• Register: EUCTR
• Last refreshed on: 18 April 2012
• Main ID: EUCTR2007-003051-36-ES
• Date of registration: 05/05/2008
• Prospective Registration: Yes
• Primary sponsor: Acadia Pharmaceuticals Inc
• Public title: Ensayo multicéntrico, doble ciego y controlado con placebo para evaluar la seguridad y la eficacia de ACP-103 en el tratamiento de la psicosis en la enfermedad de Parkinson. A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease
• Scientific title: Ensayo multicéntrico, doble ciego y controlado con placebo para evaluar la seguridad y la eficacia de ACP-103 en el tratamiento de la psicosis en la enfermedad de Parkinson. A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease
• Date of first enrolment: 01/07/2008
• Target sample size: 280
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-003051-36
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Austria, Portugal, Spain, Sweden

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male or female of 40 years of age or older with a clinical diagnosis of idiopathic Parkinson’s disease with a minimum duration of 1 year, defined as the presence of at least three of the following cardinal features, in the absence of alternative explanations or atypical features: rest tremor, rigidity, bradykinesia and/or akinesia, postural and gait abnormalities.
2. 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]), for at least one month prior to randomization, during the study, and one month following completion of the study.
3. Subjects must have psychotic symptoms that developed after the diagnosis of Parkinson’s Disease was established. These symptoms must include visual hallucinations and/or auditory hallucinations and/or delusions.
4. Psychotic symptoms must have been present for at least one month and the subject must have actively experienced psychotic symptoms during the month prior to the Screening visit.
5. Symptoms severe enough to warrant treatment with an antipsychotic agent as documented by items A and B of the NPI, and defined as the sum of Hallucinations (Frequency × Severity) and Delusions (Frequency × Severity) = a total of 4.
6. Subject must be on stable dose of anti-Parkinson’s medication for 1 month prior to Study Day 1 (Baseline) and during the trial.
7. 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
8. Subject must have clear sensorium at study entry (i.e., oriented to time, person, and place) and thus not be delirious.
9. The subject is willing and able to provide consent
10. 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 with psychotic symptoms (hallucinations and delusions) which could be better explained as a part of a toxic, metabolic or infection-induced delirium/encephalopathy, psychosis due to substance abuse, psychosis associated with schizophrenia, bipolar disorder or psychotic depression.
2. Subject has a history of significant psychotic disorders prior to or concomitantly with the diagnosis of Parkinson’s disease including, but not limited to, schizophrenia or bipolar disorder.
3. Subject has atypical parkinsonism (Parkinson’s plus, MSA, PSP), or secondary parkinsonism variants such as tardive or medication induced parkinsonism.
4. Subject has received previous ablative stereotaxic surgery (i.e., pallidotomy and thalamotomy) to treat Parkinson’s disease.
5. Subject had dementia prior to or concomitantly with the diagnosis of Parkinson’s disease that may be inconsistent with a PD diagnosis.
6. A score on the Mini-Mental State Examination (MMSE) of <21
7. Subject has history of cerebrovascular ischemic syndrome (stroke) that impairs their ability to complete the MMSE.
8. Subject has visual impairment including visual acuity problems (e.g., cataracts) that may impair assessments or better explain visual hallucinations.
9. Subject is using or has used any of the medications prohibited or restricted as described in Appendix 1 (Prohibited and Restricted Concomitant Medications).
10. Subject has current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder, including cancer or malignancies, which would affect the subject’s ability to participate in the study.
11. Subject has had a myocardial infarction in last six months
12. Subject has moderate to severe congestive heart failure (NYHA class III or IV)
13. Subject has known history or symptoms of long QT syndrome
14. Subject is on medications known to prolong the QT interval (as described in Appendix 1)
15. Subject has a screening and baseline electrocardiogram (ECG) with Bazett’s corrected QT (QTcB) of greater than 460 msec if male or 470 msec if female.
16. Subject has clinically significant laboratory abnormalities that in the judgment of the investigator would jeopardize the safe conduct of the study
17. Subject is pregnant or breastfeeding. Female subjects of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at Study Day 1 (Baseline) prior to randomization.
18. Subject has any surgery planned during the screening, treatment or follow-up periods.
19. Subject is likely to have an allergy or sensitivity to ACP-103 based on known allergies to drugs of the same class.
20. Subject has previously participated in any prior clinical study with ACP-103, and/or received of any other investigational drug within 30 days prior to the screening visit.
21. 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

Psicosis en la enfermedad de Parkinson. 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: 5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

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-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): The combined score for the Hallucinations and Delusions domains of the Scale for the Assessment of Positive Symptoms (SAPS). The primary endpoint will be the difference in the mean absolute change in the combined SAPS Hallucinations and Delusions scores between an active arm and the placebo arm from Study Day 1 (Baseline) to Study Day 42.

Secondary Objective: • To demonstrate that ACP-103 does not worsen motor symptoms of PD in PDP subjects
• To evaluate the effect of ACP-103 on global severity of and improvement in psychosis in subjects with PDP
• To demonstrate the safety and tolerability of ACP-103

Main Objective: To demonstrate the antipsychotic efficacy of ACP-103 in subjects with PDP as measured by a decrease in the severity and/or frequency of hallucinations and/or delusions.

Secondary ID(s)

ACP-103-014

2007-003051-36-AT