Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia

• Register: ClinicalTrials.gov
• Last refreshed on: 28 August 2023
• Main ID: NCT03121586
• Date of registration: 13/04/2017
• Prospective Registration: No
• Primary sponsor: ACADIA Pharmaceuticals Inc.
• Public title: Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia
• Scientific title: A 52-Week, Open-Label, Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia
• Date of first enrolment: January 2017
• Target sample size: 500
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03121586
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Argentina, Bulgaria, Canada, Croatia, Czechia, Hungary, Italy, Lithuania, Poland, Russian Federation, Serbia, Spain, Ukraine, United States

Contacts

• Name: Dragana Bugarski-Kirola, MD

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Patient is able to understand and provide signed informed consent

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 scale

3. Is completing the Week 6 visit in Study ACP-103-034 or the Week 26 visit in Study
ACP-103-038 or 064 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 a antipsychotic

4. If the subject is female, she must not be pregnant or breastfeeding. She must also 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

5. The main background antipsychotic with which the subject is being treated must
continue to be on one of the antipsychotics listed below:

- Aripiprazole

- Aripiprazole long-acting injectables:

- Abilify Maintena®

- Aristada®

- Asenapine

- Risperidone

- Risperidone long-acting injection

- Olanzapine

- Paliperidone extended release (ER) (=9 mg)

- Paliperidone palmitate

- Invega Sustenna® (=156 mg)

- Invega Trinza® (=546 mg)

- Trevicta® (=350 mg)

- Xeplion® (=100 mg)

- Lurasidone

- Cariprazine

- Brexpiprazole

- Asenapine

Exclusion Criteria:

1. Patient 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 -064)

2. A urine drug screen (UDS) result at Baseline that indicates the presence of any tested
prohibited substance of potential abuse

1. Subjects from Studies 034 and 038 with a result indicating the presence of
marijuana are permitted, if allowed by medical regulations, if they agree to
abstain from marijuana use during the study and the medical monitor approves the
subject's participation

2. Subjects from Study 064 with a result indicating the presence of marijuana are
not permitted in the study

3. Is taking a medication or drug or other substance that is prohibited according to this
protocol

4. Known family or personal history or symptoms of long QT syndrome or risk factors for
torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia
or hypomagnesemia, and the presence of congenital prolongation of the QT interval

5. Patient has current evidence of a serious and/or unstable psychiatric, neurologic,
cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other
medical disorder, including cancer or malignancies, which would affect the patient's
ability to participate in the study.

Patients will be evaluated at screening to ensure that all criteria for study participation
are met. Patients may be excluded from the study based on these assessments (and
specifically if it is determined that their baseline health and psychiatric condition do
not meet all pre-specified entry criteria).



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Schizophrenia

Intervention(s)

Drug: Pimavanserin

Primary Outcome(s)

Evaluate the long-term safety and tolerability of pimavanserin (e.g., Summary of Treatment-Emergent Adverse Events [Safety and Tolerability]) [Time Frame: 52 weeks]

Secondary ID(s)

ACP-103-035

2016-003435-38

Source(s) of Monetary Support

Please refer to primary and secondary sponsors