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Antipsychotic

LB-102, 75 mg QD for Schizophrenia

Phase 2
Recruiting
Led By John Kane, MD
Research Sponsored by LB Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must be willing to be hospitalized for the duration of the inpatient period of the study
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days (4 weeks)
Awards & highlights

Study Summary

This trial is being conducted to assess the effectiveness and safety of a drug called LB-102 in adult patients with schizophrenia experiencing worsening symptoms. The study will compare the effects of LB-102 to a placebo

Who is the study for?
This trial is for adults with acute schizophrenia experiencing a worsening of symptoms. Participants must have a diagnosis of schizophrenia and be currently experiencing an acute episode to qualify.Check my eligibility
What is being tested?
The study tests LB-102's effectiveness in treating acute schizophrenia. It's randomized, meaning patients are randomly assigned to receive either LB-102 or a placebo, and neither the participants nor the researchers know who gets which (double-blind).See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones for antipsychotic medications like LB-102 can include drowsiness, weight gain, dry mouth, restlessness, and sometimes more serious effects like movement disorders.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing to stay in the hospital for the study period.
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I am between 18 and 55 years old and have been diagnosed with schizophrenia.
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I am currently experiencing a severe worsening of my psychotic symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days (4 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days (4 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at 28 days
Secondary outcome measures
Change from Baseline in the Clinical Global Impressions Severity of Illness scale (CGI-S) score
Change from baseline on PANSS subscale and Marder factor scores
Other outcome measures
Change from baseline on Cogstate test score

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: LB-102, 75 mg QDExperimental Treatment1 Intervention
Oral LB-102: 75 mg (n ~ 105)
Group II: LB-102, 50 mg QDExperimental Treatment1 Intervention
Oral LB-102: 50 mg (n ~ 105)
Group III: LB-102, 100 mgExperimental Treatment1 Intervention
Oral LB-102: 100 mg (n ~ 35)
Group IV: Placebo comparatorPlacebo Group1 Intervention
Drug: Placebo Matched placebo tablets
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LB-102
2021
Completed Phase 1
~80

Find a Location

Who is running the clinical trial?

LB Pharmaceuticals Inc.Lead Sponsor
2 Previous Clinical Trials
80 Total Patients Enrolled
2 Trials studying Schizophrenia
80 Patients Enrolled for Schizophrenia
John Kane, MDPrincipal InvestigatorThe Zucker Hillside Hospital
1 Previous Clinical Trials
404 Total Patients Enrolled
1 Trials studying Schizophrenia
404 Patients Enrolled for Schizophrenia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants currently being actively enrolled in this research study?

"Indeed, the current information on clinicaltrials.gov confirms that this trial is actively seeking participants. The initial posting of the study took place on December 4th, 2023 and it was most recently updated on December 12th, 2023. A total of 350 patients are being sought across a network of 25 different sites."

Answered by AI

Does this medical study enroll individuals who are aged 55 years or older?

"This clinical investigation is seeking individuals who have reached the age of majority but are not older than 55 years."

Answered by AI

At how many different sites is this clinical trial currently being conducted?

"This study is currently enrolling a total of 25 patients. Notable enrollment sites include Pillar Clinical Research in Bentonville, CelExel Clinical Innovations in Bellflower, and Synexus in Cerritos. Additionally, there are 25 other locations where participants can be enrolled."

Answered by AI

Has the Food and Drug Administration granted approval for the daily administration of LB-102 at a dosage strength of 50 milligrams?

"Based on our assessment, LB-102 at a dosage of 50 mg once daily is estimated to have a safety rating of 2. This evaluation is based on the fact that this trial belongs to Phase 2, indicating some existing data supporting its safety but lacking evidence for efficacy."

Answered by AI

What is the current number of individuals being admitted into this clinical investigation?

"To successfully conduct this study, a total of 350 eligible participants who meet the inclusion criteria are needed. LB Pharmaceuticals Inc., the sponsor of the trial, will oversee operations from various sites including Pillar Clinical Research in Bentonville, California and CelExel Clinical Innovations in Bellflower, Florida."

Answered by AI

Do I meet the necessary criteria to participate in this clinical investigation?

"In order to meet the eligibility criteria for this clinical trial, participants must have a diagnosis of schizophrenia and fall within the age range of 18 to 55 years. The study has capacity to enroll up to 350 individuals."

Answered by AI

Who else is applying?

What site did they apply to?
ProScience Research Group
Behavioral Clinical Research, Inc.
Segal Institute for Clinical Research
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

I have been on many different medications. Pills and injections and nothing has worked. Please help.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Randomized, Double-blinded, Placebo-controlled, Evaluating the Treatment With LB-102 in Patients With Acute Schizophrenia
2023. "Randomized, Double-blinded, Placebo-controlled, Evaluating the Treatment With LB-102 in Patients With Acute Schizophrenia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06179108.
All > Pflugerville Tx > Paid Studies Pittsburgh
~233 spots leftby Sep 2025
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