- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06179108
Randomized, Double-blinded, Placebo-controlled, Evaluating the Treatment With LB-102 in Patients With Acute Schizophrenia
A Randomized, Double-blinded, Placebo-controlled, Multicenter Study to Evaluate the Antipsychotic Efficacy and Safety of LB-102 in the Treatment of Adult Patients With Acute Schizophrenia
Study Overview
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Leslie Callahan, RN, BSN
- Phone Number: 212-605-0148
- Email: Nova1@LBPharma.us
Study Contact Backup
- Name: Anna Eramo, MD
- Phone Number: 212-605-0148
- Email: Nova1@LBPharma.us
Study Locations
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-
Arkansas
-
Bentonville, Arkansas, United States, 72712
- Recruiting
- Pillar Clinical Research
-
Contact:
- Eric Foster
- Phone Number: 479-367-2688
- Email: efoster@pillarhc.com
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Principal Investigator:
- Fayz Hudefi, MD
-
Contact:
- Brittany Smith
- Phone Number: 479-367-2688
- Email: bsmith@pillarhc.com
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Little Rock, Arkansas, United States, 72211
- Recruiting
- Woodland Internation Research Group
-
Principal Investigator:
- George Konis, MD
-
Contact:
- Chequette Withers
- Phone Number: 501-221-8681
- Email: cwithers@ergclinical.com
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Contact:
- Jordan Harmon
- Phone Number: 501-221-8681
- Email: jharmon@ergclinical.com
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Rogers, Arkansas, United States, 72758
- Recruiting
- Woodland Research Northwest
-
Contact:
- Robert Boylls
- Phone Number: 479-927-3000
- Email: Rboylls@ergclinical.com
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Principal Investigator:
- Robert Billingsley, MD
-
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California
-
Bellflower, California, United States, 90706
- Recruiting
- CelExel Clinical Innovations
-
Contact:
- Jenny Orellana
- Phone Number: 562-748-4999
- Email: j.orellana@cenexel.com
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Principal Investigator:
- Robert Bota, MD
-
Contact:
- Nikita Vera
- Phone Number: 562-748-4999
- Email: n.vera@cenexel.com
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Cerritos, California, United States, 90703
- Recruiting
- Synexus
-
Contact:
- Stephen Ingalls
- Phone Number: 562-246-3800
- Email: Stephen.ingalls@globalaes.com
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Contact:
- Safaaifo Mailoto
- Phone Number: 562-246-3800
- Email: Safaaifo.mailoto@globalaes.com
-
Principal Investigator:
- Morteza Marandi, MD
-
Culver City, California, United States, 90230
- Recruiting
- ProScience Research Group
-
Principal Investigator:
- Marina Bussel, MD
-
Contact:
- Sara Robles
- Phone Number: 424-227-8127
- Email: Sara.robles@prosciencerg.com
-
Contact:
- Ricardo Hernandez-Escamilla
- Phone Number: 424-227-8127
- Email: ricardo.hernandez@prosciencerg.com
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Garden Grove, California, United States, 92845
- Recruiting
- CelExel CNS
-
Principal Investigator:
- David Walling, MD
-
Contact:
- Nithya Bamunarachchi
- Phone Number: 714-799-7799
- Email: N.bamunuarachchi@cenexel.com
-
Contact:
- Ashley Thrower
- Phone Number: 714-799-7799
- Email: A.thrower@cenexel.com
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Lemon Grove, California, United States, 91945
- Recruiting
- Synergy Research
-
Contact:
- Susan Manivanh
- Phone Number: 619-303-6130
- Email: manivanhs@synergysandiego.com
-
Contact:
- Jennifer Cerrillo
- Phone Number: 619-303-6130
- Email: cerrilloj@synergysandiego.com
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Principal Investigator:
- Charmaine Semeniuk, MD
-
Riverside, California, United States, 92506
- Recruiting
- CenExel CIT Riverside
-
Contact:
- John Ann
- Phone Number: 951-300-4924
- Email: j.ann@cenexel.com
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Contact:
- Viviana Rivera
- Phone Number: 951-300-4924
- Email: v.rivera@cenexel.com
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Principal Investigator:
- Evagelos Coskinas, MD
-
Santa Ana, California, United States, 92705
- Recruiting
- NRC Research Institute
-
Contact:
- Tamara C Luechinger
- Phone Number: 714-289-1100
- Email: tluechinger@nrcresearch.com
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Contact:
- Emma Martinez
- Phone Number: 714-289-1100
- Email: emartinez@nrcresearch.com
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Principal Investigator:
- Tony Ortiz
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Florida
-
Hollywood, Florida, United States, 33021
- Recruiting
- Behavioral Clinical Research, Inc.
-
Principal Investigator:
- Olga Lapeyra, MD
-
Contact:
- Annalise Alvarez
- Phone Number: 954-375-7794
- Email: aalvarez@segaltrials.com
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Contact:
- Jessmin Richani
- Phone Number: (954) 375-7794
- Email: jrichani@segaltrials.com
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Hollywood, Florida, United States, 33024
- Recruiting
- CenExel RCA
-
Contact:
- Stephanie Diaz
- Phone Number: 5203 954-990-7649
- Email: s.diaz@cenexel.com
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Contact:
- Sara Gomez
- Phone Number: 5203 954-990-7649
- Email: s.gomez@cenexel.com
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Principal Investigator:
- Edwin Gomez, MD
-
Miami Lakes, Florida, United States, 33016
- Recruiting
- Segal Institute for Clinical Research
-
Principal Investigator:
- Rishi Kakar, MD
-
Contact:
- Orbrena Wellons
- Phone Number: 786-570-1971
- Email: owellons@segaltrials.com
-
Contact:
- Linda Frazier
- Phone Number: 786-570-1971
- Email: lfrazier@segaltrials.com
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Georgia
-
Atlanta, Georgia, United States, 30331
- Recruiting
- CenExel ACMR
-
Principal Investigator:
- Maria Johnson, MD
-
Contact:
- Samantha Stellenberg
- Phone Number: 404-881-5800
- Email: s.stellenberg@cenexel.com
-
Decatur, Georgia, United States, 30030
- Recruiting
- CenExel iResearch
-
Contact:
- Casey Chacona
- Phone Number: 404-537-1281
- Email: c.chacona@cenexel.com
-
Contact:
- Mia Brown
- Phone Number: 404-537-1281
- Email: m.brown@cenexel.com
-
Principal Investigator:
- Saundra Maas-Robinson, MD
-
-
Illinois
-
Chicago, Illinois, United States, 60640
- Recruiting
- Uptown Research Institute
-
Contact:
- Alecia Halstead
- Phone Number: 119 773-989-8313
- Email: ahalstead@uptownresearch.com
-
Contact:
- Gwen Jacobs
- Phone Number: 112 773-989-8313
- Email: gjacobs@uptownresearch.com
-
Principal Investigator:
- John G Sonnenberg, PhD
-
Sub-Investigator:
- Alecia E Halstead
-
Chicago, Illinois, United States, 60641
- Recruiting
- Pillar Clinical Research
-
Principal Investigator:
- Roueen Rafeyan, MD
-
Contact:
- Hannah Joseph
- Phone Number: 224-534-7332
- Email: hjoseph@pillarhc.com
-
Contact:
- Ruby Hernandez
- Phone Number: 224-534-7332
- Email: rhernandez@pillarhc.com
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-
Maryland
-
Gaithersburg, Maryland, United States, 20877
- Recruiting
- CenExel CBH
-
Principal Investigator:
- Elia Acevedo-Diaz, MD
-
Contact:
- Frank Rollo
- Phone Number: 301-251-4702
- Email: f.rollo@cenexel.com
-
Contact:
- Tristan Torres
- Phone Number: 301-251-4702
- Email: t.torres@cenexel.com
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-
New Jersey
-
Berlin, New Jersey, United States, 08009
- Recruiting
- CenExel HRI
-
Principal Investigator:
- Elan Cohen, PhD
-
Contact:
- Amanda Hulme
- Phone Number: 815 856-452-9901
- Email: a.hulme@cenexel.com
-
Contact:
- Lindsay Moellers
- Phone Number: 814 826-452-9901
- Email: l.moellers@cenexel.com
-
-
New York
-
Staten Island, New York, United States, 10314
- Recruiting
- Richmond Behavioral Associates
-
Contact:
- Alina Goldstein
- Phone Number: 1311 718-317-5522
- Email: agoldstein@ergclinical.com
-
Contact:
- Justin Kadro
- Phone Number: 1315 718-317-5522
- Email: jkadro@ergclinical.com
-
Principal Investigator:
- Adam Smith, PhD
-
-
Ohio
-
Dayton, Ohio, United States, 45417
- Recruiting
- Midwest Clinical Research Center
-
Contact:
- Rebecca Vernon
- Phone Number: 937-424-1050
- Email: rvernon@ergclinical.com
-
Contact:
- Louis Wagner
- Phone Number: 937-424-1050
- Email: lwagner@ergclinical.com
-
Principal Investigator:
- Richard Sanders, MD
-
North Canton, Ohio, United States, 44720
- Recruiting
- Neuro-Behavioral Clinical Research
-
Principal Investigator:
- Shishuka Malhotra, MD
-
Contact:
- Garrett Haverstick
- Phone Number: 330-493-1118
- Email: ghaverstick@nb-cr.com
-
Contact:
- Aparna Pabbisetty
- Phone Number: 330-493-1118
- Email: apabbisetty@nb-cr.com
-
-
Texas
-
Austin, Texas, United States, 78754
- Recruiting
- Community Clinical Research
-
Principal Investigator:
- David Brown, MD
-
Contact:
- Sarmistha Sarkar
- Phone Number: 512-597-6710
- Email: sarmistha.sarkar@communityclinical.com
-
Contact:
- Missy Ward
- Phone Number: (512) 597-6704
- Email: missy.ward@communityclinical.com
-
DeSoto, Texas, United States, 75115
- Recruiting
- InSite Clinical Research
-
Principal Investigator:
- Rajinder Shiwach, MD
-
Contact:
- Cristen Cooper
- Phone Number: 214-420-1484
- Email: ccooper@incr.us
-
Contact:
- Patrick Keyes
- Phone Number: 214 420-1484
- Email: pkeyes@incr.us
-
Richardson, Texas, United States, 75080
- Recruiting
- Pillar Clinical Research
-
Principal Investigator:
- Scott Bartley, MD
-
Contact:
- Jordan Cruz
- Phone Number: 214-396-4844
- Email: jcruz@pillarhc.com
-
Contact:
- Dana Siler
- Phone Number: (214) 396-4844
- Email: dsiler@pillarhc.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
A patient will be eligible for inclusion in the study if they meet all of the following criteria:
- Patient who is able to provide written informed consent (as required by Institutional Review Board [IRB]) prior to the initiation of any protocol-required procedures.
- Must be willing to be hospitalized for the duration of the inpatient period of the study.
- Have stable living environment when not in a hospital.
- Male and female patients 18 to 55 years of age inclusive at the time of informed consent with a diagnosis of schizophrenia as defined by DSM-5 criteria and confirmed by the MINI 7.0.2 .
- Body mass index (BMI) must be ≥18 and ≤40 kg/m2.
- Patient who experiencing an acute exacerbation of psychotic symptoms, AND the patient requires hospitalization OR if already an inpatient at Screening, has been hospitalized for onset < 2 weeks for the current exacerbation.
Patients who are experiencing an acute exacerbation of psychotic symptoms and marked deterioration of usual function as demonstrated by meeting ALL of the following criteria at the Screening and Baseline visits:
- Total PANSS score between 80 and 120, inclusive, and
- Score of ≥4 (moderate or greater) for ≥2 of the following Positive Scale (P) items: Item 1 (P1; delusions), Item 2 (P2; conceptual disorganization), Item 3 (P3; hallucinatory behavior), Item 6 (P6; suspiciousness/persecution), and
- CGI-S score ≥4 (moderately to severely ill).
- Have received previous antipsychotic treatment (dose and duration as per the label) and who showed a previous good response to such antipsychotic treatment (other than clozapine) in the last 12 months, according to the Investigator's opinion.
- Have history of relapse and/or exacerbation of symptoms when they were not receiving antipsychotic treatment.
- Patients willing to discontinue all prohibited psychotropic medications prior to Screening, if determined to be clinically appropriate by the Investigator, and not for the sole purpose of inclusion in the trial.
Exclusion Criteria:
A patient will be excluded from the study if they meet any of the following criteria:
Sex and Reproductive Status
- Sexually active females of childbearing potential and male patients who are not practicing 2 different methods of birth control with their partner during the trial and for 30 days after the last dose of trial medication or who would not remain abstinent during the trial and for 30 days after the last dose.
- Females who are breastfeeding or who have a positive pregnancy test result prior to receiving trial medication.
- Patients who presented with a first episode of schizophrenia.
- Improvement of ≥20% in total PANSS score between the Screening and Baseline assessments.
- History of treatment resistance to schizophrenia medications defined as failure to respond to 2 adequate courses of pharmacotherapy (dose and duration as per the label) or required clozapine within the last 12 months.
- Current DSM-5 Axis I diagnosis other than schizophrenia.
- Risk for suicidal behavior during the study.
- Risk of violent or destructive behavior.
- Patients with clinically significant tardive dyskinesia.
- Patients with a score of 3 on the Barnes Akathisia Rating Scale (BARS) global clinical assessment of akathisia.
- Patients who met DSM-5 criteria for substance abuse or dependence within the past 1 year.
- Patients with hypothyroidism or hyperthyroidism or clinically significant abnormal thyroid function.
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results.
Patients with insulin-dependent diabetes mellitus (i.e., any patient using insulin) are excluded. Patients with non-insulin-dependent diabetes mellitus may be eligible for the trial if their condition is stable as determined by satisfying ALL of the following criteria:
- Glycosylated hemoglobin (HbA1c) <7.0%, and
- Screening glucose must have been ≤125 mg/dL or ≤6.94 mmol/L (fasting) or <200 mg/dL or <11.1 mmol/L (nonfasting), and
- Patient had been maintained on a stable regimen of oral antidiabetic medication(s) for at least 28 days prior to Screening or diabetes had been well controlled by diet for at least 28 days prior to Screening, and
- Patient had no hospitalizations within the 12 months prior to Screening due to diabetes or complications related to diabetes, and
- Patient's diabetes should not be newly diagnosed during Screening for the trial.
- Patients with uncontrolled hypertension or symptomatic hypotension, or orthostatic hypotension
- Patients with known ischemic heart disease or any history of myocardial infarction, congestive heart failure.
- Patients with epilepsy or a history of seizures.
- Patients with a positive urine drug screen or a positive blood alcohol test.
- Patients with a history of alcohol use or substance use disorder (by DSM-5 criteria) within 12 months of Screening or a positive screen for drugs of abuse at Screening.
The following laboratory test results are exclusionary:
- Platelets ≤75,000/µL or ≤75×109/L
- Hemoglobin ≤9 g/dL or ≤90 g/L
- Neutrophils, absolute ≤1000/µL or ≤1×109/L
- AST and ALT >2 × upper limit of normal (ULN)
- CPK >3 × ULN, unless discussed with and approved by the Medical Monitor
- Creatinine ≥2 mg/dL or ≥176.8 µmol/L
- Estimated creatinine clearance of <45 mL/min, calculated using the Cockcroft-Gault equation, at Screening
- HbA1c ≥7.0%
- Abnormal free T4 (during Screening), unless discussed with and approved by the Medical Monitor.
- Clinically significant abnormal finding on the triplicate set of electrocardiograms (ECGs) or evidence of any of the following cardiac conduction abnormalities at Screening.
- Patients who are currently taking oral antipsychotic medications, monoamine oxidase inhibitors (MAOIs), anticonvulsants (e.g., lamotrigine, Depakote), tricyclic antidepressants (e.g., imipramine, desipramine), selective serotonin reuptake inhibitors, and any other antidepressants or any other psychoactive medications (except lorazepam, zolpidem, zaleplon, eszopiclone, or similar benzodiazepines, diphenhydramine, benztropine, and propranolol). The medications should not be discontinued solely to make the patient eligible for enrollment in the study.
- Patients who received electroconvulsive therapy, or Transcranial Magnetic Stimulation (TMS).
- Patients with a history of neuroleptic malignant syndrome.
- Patients with a history of allergic response
- Prisoners or patients who were compulsorily detained (involuntarily hospitalized) for treatment of either a psychiatric or physical illness or have been in the last 6 months prior to the Screening Visit
Patients who have participated in another clinical study in which they received an experimental or investigational drug agent within 3 months of Screening.
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LB-102, 50 mg QD
Oral LB-102: 50 mg (n ~ 105)
|
LB-102 is a dopamine D2/3 and 5HT7 antagonist.
|
Experimental: LB-102, 75 mg QD
Oral LB-102: 75 mg (n ~ 105)
|
LB-102 is a dopamine D2/3 and 5HT7 antagonist.
|
Experimental: LB-102, 100 mg
Oral LB-102: 100 mg (n ~ 35)
|
LB-102 is a dopamine D2/3 and 5HT7 antagonist.
|
Placebo Comparator: Placebo comparator
Drug: Placebo Matched placebo tablets |
LB-102 is a dopamine D2/3 and 5HT7 antagonist.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at 28 days
Time Frame: 28 days (4 weeks)
|
The PANSS is a scale used for measuring symptom severity of patients with schizophrenia.
The PANSS rating is composed of 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales.
Patients are scored from 1 to 7 on each symptom scale.
The total score of the PANSS is a minimum of 30 and a maximum of 210.
A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.
|
28 days (4 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in the Clinical Global Impressions Severity of Illness scale (CGI-S) score
Time Frame: 28 days
|
The CGI-Severity rates illness severity on a scale from 1 to 7, and has been shown to correlate with PANSS.
|
28 days
|
Change from baseline on PANSS subscale and Marder factor scores
Time Frame: 28 days
|
The PANSS subscales (positive, negative, and general psychopathology) and Marder factors measure changes in total PANSS score by subtype.
|
28 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline on Cogstate test score
Time Frame: 28 days
|
Cogstate scores are a measure of cognition
|
28 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: John Kane, MD, The Zucker Hillside Hospital
Publications and helpful links
General Publications
- Grattan V, Vaino AR, Prensky Z, Hixon MS. Antipsychotic Benzamides Amisulpride and LB-102 Display Polypharmacy as Racemates, S Enantiomers Engage Receptors D2 and D3, while R Enantiomers Engage 5-HT7. ACS Omega. 2019 Aug 15;4(9):14151-14154. doi: 10.1021/acsomega.9b02144. eCollection 2019 Aug 27.
- Biernat L, Grattan VT, Hixon MS, Prensky Z, Vaino AR. A randomized, double-blind, placebo controlled, phase 1 study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of LB-102, a selective dopamine D2/3/5-HT7 inhibitor. Psychopharmacology (Berl). 2022 Sep;239(9):3009-3018. doi: 10.1007/s00213-022-06185-7. Epub 2022 Jul 16.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LB-102-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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