Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia

Phase 3

Terminated

• Conditions: Schizophrenia
• Interventions: Drug: Pimavanserin

• Registration Number: NCT03121586
• Lead Sponsor: ACADIA Pharmaceuticals Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-04-13
• Study First Submitted QC: 2017-04-17
• Study First Posted: 2017-04-20
• Primary Completion: 2024-06
• Study Completion: 2024-06
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 996

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Drug - Pimavanserin	Pimavanserin	Pimavanserin 34 mg, 20 mg, or 10 mg, + background antipsychotic, taken once daily by mouth

Primary Outcome Measures

Name	Time	Method
Evaluate the long-term safety and tolerability of pimavanserin (e.g., Summary of Treatment-Emergent Adverse Events [Safety and Tolerability])	52 weeks	Evaluate the long-term safety and tolerability of pimavanserin after 52 weeks of adjunctive treatment in subjects with schizophrenia

Trial Locations

Locations (161)

171-Alea Research Institute; 🇺🇸 Phoenix, Arizona, United States

156-Woodland International Research Group, LLC; 🇺🇸 Little Rock, Arkansas, United States

111-Woodland Research Northwest, LLC; 🇺🇸 Rogers, Arkansas, United States

167-CITrials - Bellflower; 🇺🇸 Bellflower, California, United States

105-ProScience Research Group; 🇺🇸 Culver City, California, United States

123-Synergy San Diego; 🇺🇸 Lemon Grove, California, United States

164-Artemis Institute for Clinical Research; 🇺🇸 San Diego, California, United States

165-CITrials; 🇺🇸 Santa Ana, California, United States

108-Collaborative Nueroscience Network, LLC; 🇺🇸 Torrance, California, United States

125-Galiz Research; 🇺🇸 Hialeah, Florida, United States

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