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Higher-Dose Maintenance With ERZOFRI 351 mg in Adults With Schizophrenia (ELEVATE)

4 november 2026 bijgewerkt door: Alejandro Alva

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

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

40

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • California
      • Orange, California, Verenigde Staten, 92866
        • ATP Clinical Research
        • Contact:
        • Hoofdonderzoeker:
          • Alejandro Alva, MD
    • Florida
      • Miami, Florida, Verenigde Staten, 33127
        • Passageway Residences of Dade County
        • Hoofdonderzoeker:
          • Ilan Melnick, MD
    • Illinois
      • Chicago, Illinois, Verenigde Staten, 60641
        • Pillar Clinical Research
        • Hoofdonderzoeker:
          • Roueen Rafeyan, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. Adults aged 18-65 years with a DSM-5 diagnosis of schizophrenia.
  2. Currently receiving monthly paliperidone palmitate long-acting injectable (INVEGA SUSTENNA or ERZOFRI) at a dose of 234 mg every 4 weeks (Q4W) for at least 3 consecutive months before Screening.
  3. Clinician-documented symptom breakthrough, destabilization, or functional deterioration occurring before the scheduled 4-week injection interval during at least 2 of the 3 most recent monthly injection cycles (not necessarily consecutive). Documentation may include progress notes indicating symptom worsening in the final week before the next injection, unscheduled clinic or emergency department visits for psychiatric symptoms, as-needed medication use for breakthrough psychosis, or clinician judgment based on longitudinal care.
  4. Documented prior tolerability to oral paliperidone or oral risperidone.
  5. Clinical Global Impression-Severity (CGI-S) score ≥3 (mildly ill) and ≤6 (severely ill) at Baseline.
  6. Able and willing to independently provide written informed consent.

Exclusion Criteria:

  1. Known hypersensitivity to paliperidone, risperidone, or any ERZOFRI formulation excipient.
  2. Renal impairment, defined as creatinine clearance (CrCl) <50 mL/min.
  3. Hemoglobin A1c (HbA1c) ≥7.0% at Screening.
  4. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2 times the upper limit of normal (ULN) at Screening.
  5. Body mass index (BMI) >43 kg/m² at Screening.
  6. QT interval corrected using Fridericia's formula (QTcF) >450 milliseconds (ms) for males or >470 ms for females at Screening. A QTcF ≥480 ms is exclusionary regardless of sex.
  7. Other clinically significant electrocardiogram abnormalities, including serious ventricular arrhythmias, clinically significant conduction abnormalities, or evidence of unstable cardiovascular disease, as determined by the investigator.
  8. Other metabolic abnormalities or medical conditions that, in the investigator's judgment, represent active, uncontrolled disease that could compromise participant safety or suitability for study participation.
  9. Current or recent (within the past 30 days) participation in another interventional clinical trial.
  10. Severe substance use disorder within the past 6 months, according to DSM-5 criteria.
  11. Pregnant or breastfeeding women, or women of childbearing potential who are unwilling or unable to comply with protocol-specified contraception requirements throughout study participation and for 45 days following the final study injection.
  12. History of neuroleptic malignant syndrome (NMS) or tardive dyskinesia (TD) requiring treatment discontinuation.
  13. Current use of strong CYP3A4 and/or P-glycoprotein (P-gp) inducers, including carbamazepine, rifampin, or St. John's Wort.
  14. Imminent risk of harm to self or others, as assessed by the investigator.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: ERZOFRI 351 mg Q4W

Participants will receive ERZOFRI 351 mg by intramuscular injection on Day 1, Week 4, and Week 8, followed by an end-of-study assessment at Week 12.
Geneesmiddel: Paliperidone Palmitate

Paliperidone palmitate extended-release injectable suspension (ERZOFRI) 351 mg administered by intramuscular injection on Day 1, Week 4, and Week 8. The Day 1 injection will be administered in the deltoid muscle; subsequent injections may be administered in the deltoid or gluteal muscle.

Andere namen:
  • ERZOFRI

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mean Change From Baseline to Week 12 in Clinical Global Impression-Severity (CGI-S) Score
Tijdsspanne: Baseline (Day 1) and Week 12

Change in clinician-rated CGI-S score from Baseline (Day 1) to Week 12. The CGI-S is a 7-point scale assessing overall severity of mental illness, ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Negative changes from baseline indicate improvement.
Baseline (Day 1) and Week 12

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Patient Clinical Global Impression-Improvement (PCGI-I) Response
Tijdsspanne: Weeks 4, 8, and 12

Proportion of participants reporting a PCGI-I score ≤2 ("much improved" or "very much improved"). The PCGI-I is a 7-point patient-reported measure of perceived global improvement, ranging from 1 (very much improved) to 7 (very much worse). Lower scores indicate greater improvement.
Weeks 4, 8, and 12
Change From Baseline in Simpson-Angus Scale (SAS) Total Score
Tijdsspanne: Baseline, Week 4, Week 8, and Week 12

Change from baseline in total SAS score. The SAS is a 10-item clinician-rated scale assessing parkinsonian signs. Each item is scored from 0 (normal) to 4 (extreme), with total scores ranging from 0 to 40; higher scores indicate greater severity of parkinsonian symptoms.
Baseline, Week 4, Week 8, and Week 12
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Items 1-7 Total Score
Tijdsspanne: Baseline, Week 4, Week 8, and Week 12

Change from baseline in the total score for AIMS Items 1-7. The AIMS is a clinician-rated scale assessing involuntary movements involving the facial/oral regions, extremities, and trunk. Items 1-7 are each scored from 0 (none) to 4 (severe), with higher scores indicating greater severity of involuntary movements. The total score for Items 1-7 ranges from 0 to 28.
Baseline, Week 4, Week 8, and Week 12
Correlation Between Serum Prolactin Concentration and Arizona Sexual Experience Scale (ASEX) Total Score
Tijdsspanne: Week 12

Correlation between serum prolactin concentration (ng/mL) and sexual dysfunction assessed using the Arizona Sexual Experience Scale (ASEX) at Week 12. The ASEX is a five-item questionnaire with total scores ranging from 5 to 30; higher scores indicate greater sexual dysfunction. The relationship will be evaluated using Pearson or Spearman correlation coefficients, as appropriate.
Week 12
Clinical Global Impression-Improvement (CGI-I) Response
Tijdsspanne: Weeks 4, 8, and 12

Proportion of participants achieving a CGI-I score ≤2 ("much improved" or "very much improved"). The CGI-I is a 7-point clinician-rated scale assessing overall clinical improvement relative to baseline, ranging from 1 (very much improved) to 7 (very much worse). Lower scores indicate greater improvement.
Weeks 4, 8, and 12
Change From Baseline in Arizona Sexual Experience Scale (ASEX) Total Score
Tijdsspanne: Baseline, Weeks 4, 8, and 12

Change from baseline in ASEX total score at Weeks 4, 8, and 12. The ASEX is a five-item questionnaire assessing sexual functioning, with total scores ranging from 5 to 30. Higher scores indicate greater sexual dysfunction.
Baseline, Weeks 4, 8, and 12

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Tijdsspanne: Day 1 through Week 12

Number and proportion of participants experiencing treatment-emergent adverse events during the study, with adverse event severity summarized.
Day 1 through Week 12
Change From Screening to Week 12 in Serum Prolactin Concentration
Tijdsspanne: Screening and Week 12

Change in serum prolactin concentration (ng/mL) from Screening to Week 12 during treatment with ERZOFRI 351 mg Q4W.
Screening and Week 12
Mean Change From Baseline in Fasting Glucose
Tijdsspanne: Baseline and Week 12

Change from baseline to Week 12 in fasting blood glucose concentration, measured in mg/dL.
Baseline and Week 12
Injection-Site Pain Severity Score
Tijdsspanne: Day 1, Weeks 4 and 8

Severity of injection-site pain following ERZOFRI administration, assessed by the investigator using an 11-point numerical rating scale ranging from 0 (no pain) to 10 (most severe pain). Higher scores indicate greater severity.
Day 1, Weeks 4 and 8
Mean Change From Baseline in QTcF Interval
Tijdsspanne: Baseline, Weeks 4, 8, and 12

Change from baseline in the QT interval corrected using Fridericia's formula (QTcF), measured in milliseconds (ms), as assessed by 12-lead electrocardiogram (ECG).
Baseline, Weeks 4, 8, and 12
All-Cause Study Discontinuation
Tijdsspanne: Day 1 through Week 12

Number and proportion of participants who discontinue the study before Week 12, with reasons for discontinuation summarized.
Day 1 through Week 12
Symptom Breakthrough Before the 4-Week Injection Interval
Tijdsspanne: Day 1 through Week 12

Proportion of participants experiencing symptom breakthrough before the scheduled 4-week injection interval during the study period, compared with their documented pre-enrollment rate of symptom breakthrough.
Day 1 through Week 12
Number of Unscheduled Clinic Visits for Psychiatric Symptoms
Tijdsspanne: Day 1 through Week 12

Total number of unscheduled clinic visits related to psychiatric symptoms occurring during the 12-week study period.
Day 1 through Week 12
Mean Change From Baseline in Body Weight
Tijdsspanne: Baseline and Week 12

Change from baseline to Week 12 in body weight, measured in kilograms (kg).
Baseline and Week 12
Mean Change From Baseline in Body Mass Index (BMI)
Tijdsspanne: Baseline and Week 12

Change from baseline to Week 12 in body mass index (BMI), calculated as body weight in kilograms divided by height in meters squared (kg/m²).
Baseline and Week 12
Mean Change From Baseline in Waist Circumference
Tijdsspanne: Baseline and Week 12

Change from baseline to Week 12 in waist circumference, measured in centimeters (cm).
Baseline and Week 12
Mean Change From Baseline in Total Cholesterol
Tijdsspanne: Baseline and Week 12

Change from baseline to Week 12 in serum total cholesterol concentration, measured in mg/dL.
Baseline and Week 12
Mean Change From Baseline in HDL Cholesterol
Tijdsspanne: Baseline and Week 12

Change from baseline to Week 12 in high-density lipoprotein (HDL) cholesterol concentration, measured in mg/dL.
Baseline and Week 12
Mean Change From Baseline in LDL Cholesterol
Tijdsspanne: Baseline and Week 12

Change from baseline to Week 12 in low-density lipoprotein (LDL) cholesterol concentration, measured in mg/dL.
Baseline and Week 12
Mean Change From Baseline in Triglycerides
Tijdsspanne: Baseline and Week 12

Change from baseline to Week 12 in serum triglyceride concentration, measured in mg/dL.
Baseline and Week 12
Injection-Site Swelling Severity Score
Tijdsspanne: Day 1, Weeks 4 and 8

Severity of injection-site swelling following ERZOFRI administration, assessed by the investigator using an 11-point numerical rating scale ranging from 0 (no swelling) to 10 (most severe swelling). Higher scores indicate greater severity.
Day 1, Weeks 4 and 8
Injection-Site Redness Severity Score
Tijdsspanne: Day 1, Weeks 4 and 8

Severity of injection-site redness following ERZOFRI administration, assessed by the investigator using an 11-point numerical rating scale ranging from 0 (no redness) to 10 (most severe redness). Higher scores indicate greater severity.
Day 1, Weeks 4 and 8
Number of Emergency Department Visits for Psychiatric Symptoms
Tijdsspanne: Day 1 through Week 12

Total number of emergency department visits related to psychiatric symptoms occurring during the 12-week study period.
Day 1 through Week 12
Number of Psychiatric Hospitalizations
Tijdsspanne: Day 1 through Week 12

Total number of psychiatric hospitalizations occurring during the 12-week study period.
Day 1 through Week 12

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Alejandro Alva

Medewerkers

Luye Pharma Group Ltd.

Onderzoekers

  • Hoofdonderzoeker: Alejandro Alva, MD, PNS Clinical Research LLC dba ATP Clinical Research

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 december 2026

Primaire voltooiing (Geschat)

1 december 2027

Studie voltooiing (Geschat)

1 december 2027

Studieregistratiedata

Eerst ingediend

9 oktober 2026

Eerst ingediend dat voldeed aan de QC-criteria

4 november 2026

Eerst geplaatst (Werkelijk)

10 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 november 2026

Laatste update ingediend die voldeed aan QC-criteria

4 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • ELEVATE

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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