Can a new pill calm a schizophrenia Flare-Up? a trial seeks answers

NCT ID NCT07734493

Recruiting now Symptom relief Sponsor: Leal Therapeutics, Inc Source: ClinicalTrials.gov ↗

First seen Jul 29, 2026 · Last updated Aug 12, 2026 · Updated 5 times

Summary

This trial tests an experimental drug called LTX-001 in adults with schizophrenia who are experiencing a sudden worsening of symptoms. Participants stay in a research unit for about five weeks and receive either LTX-001 or a placebo. The main goal is to see if the drug is safe and tolerable, while also measuring how the body processes it and whether it shows any early signs of easing symptoms.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: an experimental drug called LTX-001
What this could lead to: If safe and effective, LTX-001 could offer a new treatment option for acute schizophrenia episodes.
What could go wrong: This is an early phase 1 trial with only 90 participants, focused on safety. It is too small and early to know if the drug actually improves symptoms.

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Conditions

The condition(s) this trial relates to.

schizophrenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

SCHIZOPHRENIA

Contacts and locations

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Locations

Behavioral Clinical Research, Inc.
RECRUITING

Hollywood, Florida, 33021, United States
CBH Health LLC., dba CenExel Gaithersburg MD
RECRUITING

Gaithersburg, Maryland, 20877, United States
CenExel Hollywood FL
RECRUITING

Hollywood, Florida, 33024, United States
CenExel iResearch, LLC
RECRUITING

Decatur, Georgia, 30030, United States
Collaborative Neuroscience Research, LLC
RECRUITING

Los Alamitos, California, 90720, United States
Hassman Research Institute, LLC
RECRUITING

Marlton, New Jersey, 08053, United States
Innovative Clinical Research, Inc.
RECRUITING

Miami Lakes, Florida, 33016, United States
Pillar Clinical Research, LLC
NOT_YET_RECRUITING

Little Rock, Arkansas, 72204, United States

Contact Email: •••••@•••••
Pillar Clinical Research, LLC
NOT_YET_RECRUITING

Richardson, Texas, 75080, United States

Contact Email: •••••@•••••
University Clinical Research-DeLand, LLC d/b/a Accel Research Sites - DeLand Clinical Research Unit
NOT_YET_RECRUITING

DeLand, Florida, 32720, United States

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