Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
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RecruitingPhase 1interventionalRules rewrite

Phase 1: testing XEP527 for Schizophrenia

This study is designed to assess the whether it is safe and how hard side effects are to live with of the effects of XEP527, with particular emphasis on disease status and its compatibility with the standard of care in patients with stable schizophrenia.

Official registry: https://clinicaltrials.gov/study/NCT07908680 · Novartis Pharmaceuticals · enrollment listed as 36

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are XEP527, or Placebo. The registry lists allocation as randomized. This study is designed to assess the whether it is safe and how hard side effects are to live with of the effects of XEP527, with particular emphasis on disease status and its compatibility with the standard of care in patients with stable schizophrenia.

They plan to enroll about 36 people at Bentonville. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Randomized, Participant and Investigator-blinded, Placebo-controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of XEP527 in Patients With Stable Schizophrenia

Interventions: XEP527, Placebo

Primary outcome (registry wording): Incidence of adverse events (AEs) and serious adverse events (SAEs)

Who it is for (from inclusion criteria)

  • Ages 18 Years to 65 Years
  • Participants 18 to 65 years of age, inclusive at screening
  • Participant agrees to be hospitalized starting at Day -1 and for at least 28 days after randomization
  • Participant meets the following requirements per PANSS at screening and baseline: Total PANSS score ≤ 110, Score ≤ 4 (moderate) for item P1-P7, Score ≤ 4 (moderate) for G9
  • Participant is treated with a single antipsychotic (typical and/or atypical) with a stable dose for at least 12 weeks prior to randomization. Participant must agree to maintain the treatment with standard of care antipsychotic for the duration of the study
  • Participants who are treated with psychotropic medications other than antipsychotics need to be taking these medications as a stable dose for at least 12 weeks before randomization

Public study contact (from the registry)

Novartis Pharmaceuticals

1-888-669-6682

novartis.email@novartis.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Related recruiting trials in this snapshot

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Phase 1 / Phase 2: testing Ocrelizumab infusion for Schizo-Affective Type of Psychosis

Some people who have what doctors currently call schizophrenia or bipolar disease may actually have a brain disease caused by auto-antibodies. Auto-antibodies are produced when the normal defense mechanism of the body goes wrong and begins to attack the body, similar to "friendly fire." Auto-antibodies attack brain receptors and then the person who has this problem begins to have hallucinations and other manifestations of schizophrenia, like feeling that people can see what they are thinking and also feeling that other people do not like them.

NCT03971487 · Official ClinicalTrials.gov record · The Methodist Hospital Research Institute

FAQ about this NCT record

Is NCT07908680 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07908680?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07908680?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary