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Not yet recruiting Phase 4 Interventional

Higher-Dose Maintenance With ERZOFRI 351 mg in Adults With Schizophrenia

ClinicalTrials.gov ID: NCT07927946

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This page only displays public information reproduced from the official ClinicalTrials.gov record NCT07927946. It adds no medical advice, opinions, or eligibility judgments. The official record remains the source of truth for eligibility criteria, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 14, 2026, 8:43 AM EST

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Official title

Exploratory Evaluation of ERZOFRI (Paliperidone Palmitate) 351 mg Q4W Maintenance in Higher-Need Patients With Schizophrenia: Clinical Global Improvement, Drug-Induced Parkinsonism, and Sexual Dysfunction Outcomes Over a 3-Month Treatment Period

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a prospective, multicenter, open-label, single-arm study evaluating ERZOFRI (paliperidone palmitate) 351 mg administered every 4 weeks as maintenance treatment in approximately 40 adults with schizophrenia who experience symptom worsening before their next scheduled monthly injection despite receiving paliperidone palmitate 234 mg every 4 weeks. Participants will receive ERZOFRI 351 mg on Day 1, Week 4, and Week 8 and will complete an end-of-study assessment at Week 12. The study will evaluate changes in clinical severity over 12 weeks and will also assess movement-related side effects and sexual functioning.

Study identification

NCT ID
NCT07927946
Recruitment status
Not yet recruiting
Study type
Interventional
Phase
Phase 4
Lead sponsor
Alejandro Alva
Network
Enrollment
40 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 2026 (Estimated)
Primary completion
Dec 2027 (Estimated)
Completion
Dec 2027 (Estimated)
Last update posted
Nov 10, 2026

2026 – 2027

United States locations

U.S. sites
3
U.S. states
3
U.S. cities
3
Facility City State ZIP Site status
ATP Clinical Research Orange California 92866 —
Passageway Residences of Dade County Miami Florida 33127 —
Pillar Clinical Research Chicago Illinois 60641 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07927946, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 10, 2026 · Synced Nov 14, 2026

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