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

4 novembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

40

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • California
      • Orange, California, États-Unis, 92866
        • ATP Clinical Research
        • Contact:
        • Chercheur principal:
          • Alejandro Alva, MD
    • Florida
      • Miami, Florida, États-Unis, 33127
        • Passageway Residences of Dade County
        • Chercheur principal:
          • Ilan Melnick, MD
    • Illinois
      • Chicago, Illinois, États-Unis, 60641
        • Pillar Clinical Research
        • Chercheur principal:
          • Roueen Rafeyan, MD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Médicament: 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.

Autres noms:
  • ERZOFRI

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Mean Change From Baseline to Week 12 in Clinical Global Impression-Severity (CGI-S) Score
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Patient Clinical Global Impression-Improvement (PCGI-I) Response
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Day 1 through Week 12

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Alejandro Alva

Collaborateurs

Luye Pharma Group Ltd.

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 décembre 2026

Achèvement primaire (Estimé)

1 décembre 2027

Achèvement de l'étude (Estimé)

1 décembre 2027

Dates d'inscription aux études

Première soumission

9 octobre 2026

Première soumission répondant aux critères de contrôle qualité

4 novembre 2026

Première publication (Réel)

10 novembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • ELEVATE

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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