A 52-Week Extension Study of Pimavanserin for the Treatment of Schizophrenia

• Register: EUCTR
• Last refreshed on: 8 January 2018
• Main ID: EUCTR2016-003435-38-HU
• Date of registration: 20/02/2017
• Prospective Registration: Yes
• Primary sponsor: ACADIA Pharmaceuticals Inc.
• Public title: A 52-Week Extension Study of Pimavanserin for the Treatment of Schizophrenia
• Scientific title: A 52-Week, Open-Label, Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia
• Date of first enrolment: 28/04/2017
• Target sample size: 550
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-003435-38
• 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

Argentina, Bulgaria, Canada, Chile, Czech Republic, Germany, Hungary, Poland, Russian Federation, Serbia, Slovakia, Spain, Ukraine, United States

Contacts

• Name: Michael Monahan
• Affiliation: ACADIA Pharmaceuticals Inc.

• Name: Michael Monahan
• Affiliation: ACADIA Pharmaceuticals Inc.

Key inclusion & exclusion criteria

Inclusion criteria:
Procedures:
1.Able to understand and provide signed informed consent, and must be able to sign and date a request for medical records and/or subject privacy form, if applicable, according to local regulations
2.Has a caregiver or some other identified responsible person (e.g., family member, social worker, caseworker, or nurse) considered reliable by the Investigator in providing support to the subject to help ensure compliance with study treatment, study visits, and protocol procedures and who is also able to provide input helpful for completing study rating scales
3.Is completing the Week 6 visit in Study ACP-103-034 or -039 or the Week 26 visit in Study ACP-103-038 while continuing to take his/her assigned dose of blinded study drug and may, in the Investigator’s opinion, benefit from continued adjunctive treatment with pimavanserin to an antipsychotic
Medical Status:
4.If female, must be of non-childbearing potential (defined as either surgically sterilized or at least 1 year postmenopausal) or must agree to use two clinically acceptable methods of contraception (e.g., oral, intrauterine device [IUD], diaphragm plus spermicide, injectable, transdermal, or implantable contraception)
•All female subjects must have a negative urine human chorionic gonadotropin (hCG) pregnancy test at Baseline and at Weeks 2, 6, 12, 20, 28, 36, 44, and 52
5.Continue to be medically stable at enrollment, in the opinion of the Investigator
Medications:
6.Continues to take a stable dose of an antipsychotic within the dose range recommended according to the local Prescribing Information
7.The main antipsychotic with which the subject is being treated must continue to be one of the antipsychotics listed below:
•Aripiprazole
•Aripiprazole long-acting injectables
–Abilify Maintena®
–Aristada®
•Asenapine
•Brexpiprazole
•Cariprazine
•Lurasidone
•Olanzapine
•Risperidone
•Risperidone long-acting injection

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 550
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Procedures:
1.Subject is judged by the Investigator or the Medical Monitor to be inappropriate for the study (e.g., significantly noncompliant in Studies ACP-103-034, -038, or -039)
Medical Status:
2.A urine drug screen (UDS) result at Baseline that indicates the presence of any tested prohibited substance of potential abuse, including marijuana (even if recreational or medicinal use is legal locally) except marijuana
•Subjects with a result indicating the presence of marijuana are permitted if they agree to abstain from marijuana use during the study and the medical monitor approved the subject's participation
3.Is taking a medication or drug or other substance that is prohibited according to this protocol, including medications that prolong the QT interval, strong cytochrome P450 (CYP) 3A4 enzyme (CYP3A4) inhibitors and inducers
4.Known family or personal history or symptoms of long QT syndrome
5.Has a QRS interval <120 ms and QTcF =460 ms OR
has a QRS interval =120 ms and QTcF =480 ms at Baseline
6.Has developed a serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies that, in the judgment of the Investigator, would jeopardize the safe participation of the subject in the study
7.Is breastfeeding or lactating
8.Has a significant sensitivity or allergic reaction to pimavanserin or its excipients
9.Subject and/or caregiver has any condition that, in the opinion of the Investigator, would interfere with the ability to comply with study instructions, might confound the interpretation of the study results, or put the subject at undue risk
10.Presence of any change in medical or treatment status which may increase the risk associated with taking study medication, would interfere with safety assessments, or would confound the interpretation of the study results, based on Investigator’s judgment
Neuropsychiatric:
11.Is at a significant risk of suicide, or is a danger to self or others, in the opinion of the Investigator
12.Has a significant risk of violent behavior in the opinion of the Investigator
Other:
13.Is an employee of ACADIA, or has a family member who is an employee of ACADIA



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

Health Condition(s) or Problem(s) studied

Schizophrenia
MedDRA version: 20.0 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders

Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Intervention(s)

Product Name: Pimavanserin
Product Code: ACP-103
Pharmaceutical Form: Tablet
INN or Proposed INN: Pimavanserin
CAS Number: 706782-28-7
Current Sponsor code: ACP-103
Other descriptive name: PIMAVANSERIN TARTRATE
Concentration type: equal
Concentration number: 10-

Product Name: Pimavanserin
Product Code: ACP-103
Pharmaceutical Form: Tablet
INN or Proposed INN: Pimavanserin
CAS Number: 706782-28-7
Current Sponsor code: ACP-103
Other descriptive name: PIMAVANSERIN TARTRATE
Concentration type: equal
Concentration number: 10-

Product Name: Pimavanserin
Product Code: ACP-103
Pharmaceutical Form: Tablet
INN or Proposed INN: Pimavanserin
CAS Number: 706782-28-7
Current Sponsor code: ACP-103
Other descriptive name: PIMAVANSERIN TARTRATE
Concentration type: equal
Concentration number: 17-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Changes from Baseline

Secondary Objective: Clinical global assessment of overall severity of symptoms

Main Objective: To evaluate the long-term safety and tolerability of pimavanserin after 52 weeks of adjunctive treatment in subjects with schizophrenia

Primary end point(s): •Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and withdrawals due to AEs
•Vital sign measurements, weight, clinical laboratory assessments, physical examination findings, electrocardiogram (ECG) parameters, the Abnormal Involuntary Movement Scale (AIMS) score, the Barnes Akathisia Rating Scale (BARS) score, and the Simpson-Angus Extrapyramidal Side Effects Scale (SAS) score
•Changes from Baseline in vital sign measurements, weight, clinical laboratory and ECG parameters, the AIMS score, the BARS score, and the SAS score
•Suicidality: the incidence of subjects with suicidal ideation or suicidal behavior during the study as assessed by the Columbia-Suicide Severity Rating Scale (C SSRS)

Secondary Outcome(s)

Secondary end point(s): •Change from Baseline in the Clinical Global Impression – Severity scale (CGI-S)
•Change from Baseline in the Clinical Global Impression of Schizophrenia Scale – Severity (CGI-SCH-S); (for subjects from Study ACP-103-038 only)

Timepoint(s) of evaluation of this end point: Change from Baseline

Secondary ID(s)

ACP-103-035

Source(s) of Monetary Support

ACADIA Pharmaceuticals Inc.