Phase 3 Schizophrenia Trial, Recruiting NCT06963034 Sponsor: Neurocrine Biosciences Condition: Schizophrenia
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Phase 3 Schizophrenia Trial, Recruiting

NCT06963034
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with schizophrenia as their primary condition
  • People who are currently experiencing a worsening or return of symptoms serious enough to require a hospital stay
  • People who are willing and able to stay in a hospital setting for the full duration of the study and follow the study's requirements
  • People who are able to stop taking certain medications, including antipsychotics, before the study begins

Who may not be able to join:

  • People who have a known allergic reaction or sensitivity to any ingredient in the study drug NBI-1117568
  • People who have an unstable or poorly managed ongoing medical condition or chronic illness
  • People who the trial doctor considers to be at immediate risk of harming themselves or others
  • People who have been diagnosed with a moderate or severe substance use problem (not including nicotine or caffeine) within the 6 months before screening
  • People whose alcohol or drug test comes back positive for substances that are not permitted in the study
  • People who have a history of not following study rules in past research, or who the trial doctor believes would have difficulty sticking to the study requirements

Important: Always verify eligibility with the trial site directly before applying.

Note: There may be additional criteria beyond those listed here that the trial site will assess.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 21 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Clinical Development Lead, Neurocrine Biosciences

Phone: 877-641-3461

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Neurocrine Biosciences
Registry
ClinicalTrials.gov
Start date
8 May 2025
Est. completion
1 October 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 5

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov