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Long-Term Safety Study of Direclidine in Adults with Schizophrenia

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study involves adults with schizophrenia, which is a mental health condition that can affect how a person thinks, feels, and behaves. The treatment being tested is called NBI-1117568, which is an investigational medication given as a hard capsule that is taken by mouth. The active ingredient in this medication is direclidine.

The purpose of this study is to evaluate the long-term safety of NBI-1117568 in adults with schizophrenia. The study will look at what unwanted effects or side effects may occur when people take this medication over an extended period of time. This is an open-label study, which means that both the participants and the doctors will know that everyone is receiving the actual medication rather than placebo.

During the study, participants will receive NBI-1117568 for up to 156 weeks, which is about three years. Some participants may be coming directly from a previous study where they were already taking this medication. Throughout the treatment period, doctors will monitor participants regularly to check for any side effects or health changes that may occur while taking the medication. The study will track and record any unwanted effects that participants experience during the treatment period.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Treatment period begins

    After enrollment in the study, the treatment period will begin. This study is described as open-label, which means that both the patient and the doctor will know which medication is being administered.

    The study will assess the long-term safety and tolerability of the investigational medication in adults with schizophrenia.

  2. Step 2

    Receiving the investigational medication

    The medication used in this study is called NBI-1117568, which contains the active substance direclidine.

    The medication is provided in the form of hard capsules that are taken orally, meaning by mouth.

    Specific dosage, frequency, and duration of administration will be determined individually during the study. The exact details regarding these parameters are not specified in the available information.

  3. Step 3

    Safety monitoring during treatment

    Throughout the treatment period, the occurrence of adverse events will be monitored. Adverse events are any unwanted medical occurrences or side effects that may happen during the study.

    This monitoring is the primary focus of the study and will continue for the duration of participation.

  4. Step 4

    Continuation of treatment

    The study is designed to evaluate long-term safety, which means participation may extend over an extended period.

    The estimated duration of the study extends until January 2032, though individual participation length may vary.

    Regular assessments will be conducted to evaluate how well the medication is tolerated over time.

Who can join the trial?

2 criteria

  • You must be between 18 and 65 years of age. If you are joining directly from a previous related study, you must have been 18 to 65 years old when you started that earlier study.
  • You must have a main diagnosis of schizophrenia, which is a mental health condition that affects how a person thinks, feels, and behaves.

Who cannot join the trial?

11 criteria

  • The study does not include children or teenagers, only adults can participate
  • Women who are pregnant or planning to become pregnant during the study cannot participate
  • Women who are breastfeeding (feeding a baby with breast milk) cannot participate
  • People who have serious medical conditions that could make the study unsafe for them cannot participate
  • People who are currently participating in another clinical trial or have recently participated in one cannot join
  • People who have a known allergy (bad reaction) to the study medicine or similar medicines cannot participate
  • People who have serious heart, liver, or kidney problems cannot participate
  • People who have a history of drug or alcohol abuse in recent months cannot participate
  • People who are taking certain medications that could interact badly with the study medicine cannot participate
  • People who have thoughts of harming themselves or others cannot participate
  • People who cannot follow the study requirements or attend all study visits cannot participate
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Investigated drugs

NBI-1117568 is an investigational medication being studied for the long-term treatment of schizophrenia in adults. This is an experimental drug that is being tested to see if it is safe when used over an extended period of time. The study will monitor how well patients tolerate this medication and track any side effects that may occur during long-term use.

What is already known about the treatment

NBI-1117568 – This is an experimental medication currently being studied in Phase 3 clinical trials for the treatment of schizophrenia in adults. The drug is being tested to evaluate its long-term safety and how well patients can tolerate it over extended periods of use. Schizophrenia is a serious mental health condition that affects how a person thinks, feels, and behaves, and this medication is being developed as a potential new treatment option for managing this disorder. The specific form of administration, exact mechanism of action, and pharmacological classification have not yet been publicly disclosed as the medication is still under investigation.

Investigated diseases

Schizophrenia – Schizophrenia is a chronic mental disorder that affects how a person thinks, feels, and behaves. People with this condition may experience episodes where they lose touch with reality, which can include hearing voices or seeing things that are not there. The disorder typically begins in late adolescence or early adulthood and tends to develop gradually over time. Individuals may have difficulty distinguishing between what is real and what is imaginary. The condition also affects a person's ability to think clearly, manage emotions, and relate to others. Symptoms can vary in intensity and may come and go in cycles throughout a person's life.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521216-19-00Protocol codeNBI-1117568-SCZ3032Estimated enrolment699 patientsSponsorNeurocrine Biosciences Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).