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ERZOFRI for Schizophrenia

(ELEVATE Trial)

Not yet recruiting at 2 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Alejandro Alva
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

AA

Alejandro Alva, MD

Principal Investigator

PNS Clinical Research LLC dba ATP Clinical Research

Are You a Good Fit for This Trial?

This trial is for adults with schizophrenia whose symptoms get worse before their next monthly injection, even though they are already getting paliperidone palmitate 234 mg every 4 weeks. Participants should be able to follow the study schedule and assessments.

Inclusion Criteria

Clinical Global Impression-Severity (CGI-S) score ≥3 and ≤6 at Baseline
I am able and willing to sign a consent form on my own.
I am 18 to 65 years old and have been diagnosed with schizophrenia.
See 3 more

Exclusion Criteria

I do not have serious heart rhythm or heart disease problems.
Imminent risk of harm to self or others as assessed by investigator
Current or recent (within 30 days) participation in another interventional clinical trial
See 11 more

What Are the Treatments Tested in This Trial?

Trial Overview

The study tests a higher dose of ERZOFRI (paliperidone palmitate) at 351 mg given every 4 weeks as maintenance treatment over a period of 12 weeks. All participants receive this higher dose to see if it better controls symptoms.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: ERZOFRI 351 mg Q4WExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alejandro Alva

Lead Sponsor

Luye Pharma Group Ltd.

Industry Sponsor

Trials
67
Recruited
9,900+

Liu Dian Bo

Luye Pharma Group Ltd.

Chief Executive Officer since 2003

Bachelor's degree in Economics from Fudan University

Cai Jianming

Luye Pharma Group Ltd.

Chief Medical Officer since 2022

MD

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