456 Participants NeededMy employer runs this trial

LB-102 for Schizophrenia

(NOVA2 Trial)

Recruiting at 12 trial locations
AE
BM
Overseen ByBranislav Mancevski, MD
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: LB Pharmaceuticals Inc.
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
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 trial tests LB-102, a new treatment for schizophrenia, a mental health condition affecting thoughts, feelings, and behavior. The study compares two doses of LB-102 against a placebo (a pill with no active medicine) to evaluate its effectiveness and safety. Individuals diagnosed with schizophrenia who experience severe symptoms may be suitable for this trial, particularly if they are willing to stay in a hospital during the study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that LB-102 is likely to be safe for humans?

Research has shown that LB-102 has been tested in people with schizophrenia and is generally well-tolerated. In one study, participants took LB-102 for four weeks, and most did not experience serious side effects. Some reported mild issues like headaches or trouble sleeping, similar to those in people taking a placebo (a pill with no active medicine).

The treatment is now undergoing testing in a later phase, indicating that earlier studies found it safe enough to proceed. This phase aims to confirm the safety and effectiveness of LB-102 in a larger group. Overall, current evidence suggests that LB-102 is safe for most people, though, like all medicines, it may not be suitable for everyone.12345

Why are researchers excited about this trial's treatments for schizophrenia?

Researchers are excited about LB-102 because it offers a potentially novel approach to treating schizophrenia. Unlike most current treatments that primarily target dopamine D2 receptors, LB-102 is a modified version of amisulpride, targeting both dopamine and serotonin receptors, which might improve symptom control. Additionally, LB-102's unique chemical structure could offer better efficacy with fewer side effects, addressing a significant limitation of existing medications like olanzapine and risperidone. This dual action and potential for improved tolerability make LB-102 a promising candidate in the fight against schizophrenia.

What evidence suggests that LB-102 might be an effective treatment for schizophrenia?

Research has shown that LB-102 may help treat schizophrenia. In this trial, participants will receive either a 50 mg or 100 mg dosage of LB-102, or a placebo, which contains no active medicine. Previous studies found that patients taking LB-102 experienced significant symptom improvements compared to those on a placebo. Specifically, the study used the PANSS score to measure symptom severity. After four weeks, patients on LB-102 had lower PANSS scores, indicating less severe symptoms. These findings suggest that LB-102 could effectively manage symptoms in adults with acute schizophrenia.12456

Who Is on the Research Team?

JK

John Kane, MD

Principal Investigator

Northwell Health

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with schizophrenia who are currently experiencing a worsening of symptoms. Participants must be willing to stay in the hospital during the study, have a BMI between 18 and 40, and meet certain symptom severity scores.

Inclusion Criteria

I am willing to stay in the hospital for the study period.
I can sign the informed consent form.
I have been diagnosed with schizophrenia.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LB-102 or placebo orally for 6 weeks

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • LB-102

Trial Overview

The study compares two fixed doses of an investigational drug called LB-102 (50 mg or 100 mg tablets) against a placebo. Participants are randomly assigned to one group and neither they nor their doctors know which treatment they're getting.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: LB-102 (50 mg tablet)Experimental Treatment1 Intervention
Group II: LB-102 (100 mg tablet)Experimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

LB Pharmaceuticals Inc.

Lead Sponsor

Trials
3
Recruited
430+

Citations

Antipsychotic Efficacy and Safety of LB-102 in the ...

In this phase 2 randomized clinical trial of participants with schizophrenia experiencing acute psychosis, 4-week treatment with once-daily LB- ...

Antipsychotic Efficacy and Safety of LB-102 in the Treatment of ...

In this phase 2 randomized clinical trial of participants with schizophrenia experiencing acute psychosis, 4-week treatment with once-daily LB- ...

LB-102 for Schizophrenia Sees Positive Phase 2 Topline ...

Subscribe Now! Advertisement. Drug Watch. |. Schizophrenia/Psychosis ...

NCT07363577 | Study to Evaluate LB-102 for the ...

History of resistant treatment to schizophrenia medications; DSM-5 diagnosis other than schizophrenia; Risk of suicidal behavior; Risk of violent or destructive ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/42018313/

Antipsychotic Efficacy and Safety of LB-102 in the ...

Objective: To evaluate the efficacy and safety of LB-102 in acute schizophrenia. ... Main outcomes and measures: The primary end point was ...

LB Pharmaceuticals Announces Publication in JAMA ...

Additional expansion opportunities for LB-102 include predominantly negative symptoms of schizophrenia, Alzheimer's disease psychosis and ...