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Efficacy, Safety, and Tolerability of NBI-1065890 in Adults with Tardive Dyskinesia

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What is this trial about?

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

The study focuses on adults with Tardive Dyskinesia, a condition that causes repeated, involuntary movements of the face, tongue, or other body parts. The investigational drug being tested is an oral capsule containing NBI-1065890. Participants will receive either this capsule or a matching placebo capsule that looks the same but does not contain active medicine.

The purpose of the study is to determine whether the investigational drug reduces the severity of the movements compared with the placebo. Participants will be randomly assigned to one of the two groups and will take the assigned capsule each day for about eight weeks, with regular clinic visits to record any changes and to monitor safety.

Effectiveness will be assessed using the Abnormal Involuntary Movement Scale (AIMS), a video‑based rating that scores the level of involuntary movements, and the Clinical Global Impression - Improvement (CGI-I), a simple overall rating of how much a person’s condition has improved. Both scales are reviewed by experts who do not know which treatment was given. Safety checks, such as blood tests and reports of side effects, will also be performed throughout the study.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization

    After you join the study, you will be assigned by a computer to receive either the test medication or a matching placebo. the assignment is double‑blind, which means neither you nor the study staff will know which one you receive.

  2. Step 2

    Baseline assessment

    Before you start taking any study medication, a series of measurements will be taken to record the severity of your tardive dyskinesia. this includes a video recording that will be evaluated with the abnormal involuntary movement scale (aims) and a clinical global impression of improvement (cgi‑i) rating. these results serve as the reference point for later comparisons.

  3. Step 3

    Start of study medication

    You will begin taking one hard gelatin capsule by mouth each day. the capsule may contain the test drug nbi‑1065890 or a matching placebo powder, depending on your randomization. the exact dose is not specified in the study information, but the capsule is taken daily for the entire 8‑week treatment period.

  4. Step 4

    Regular monitoring visits

    Throughout the 8‑week treatment period, you will attend scheduled visits (in person or remotely) to check for side effects, ensure the medication is being taken as directed, and collect any additional safety information. these visits help the study team monitor your health while you remain blinded to the treatment you receive.

  5. Step 5

    Week 8 assessment

    At the end of week 8, the same evaluations performed at baseline will be repeated. a new video will be recorded and scored with the aims scale, and a clinician will assign a cgi‑i rating to determine any change in your condition. these results are used to assess the effectiveness of the test medication compared with placebo.

  6. Step 6

    Final visit and end of treatment

    After the week 8 assessment, you will stop taking the study capsule. a final safety check will be performed to record any remaining side effects or concerns. the study medication period is considered complete at this point.

Who can join the trial?

7 criteria

  • Be an adult (age 18 years or older) who can take part in the study.
  • Have a doctor‑confirmed diagnosis of one of these mental health conditions: schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder (MDD), and have had the diagnosis for at least three months before screening.
  • Have a doctor‑confirmed diagnosis of tardive dyskinesia (TD) that was caused by medicines called neuroleptics (antipsychotic drugs), and have had TD for at least three months before screening.
  • Show a moderate or severe level of TD, measured by the Abnormal Involuntary Movement Scale (AIMS). The total AIMS score (items 1‑7) must be 6 or higher, and the overall movement severity (item 8) must be judged as moderate or severe by a video reviewer who does not know which treatment you receive.
  • Be willing to have video recordings of your movement assessment reviewed by a certified, blinded rater.
  • Both men and women are eligible to join the study.
  • People who are considered “vulnerable” (for example, those who may have limited ability to protect their own interests) may participate if they meet all other criteria.

Who cannot join the trial?

6 criteria

  • Having Parkinson‑like movement problems (known as parkinsonism) or noticeable extra movement side effects, as shown by a score higher than allowed on a movement‑assessment test (Modified Simpson‑Angus Scale).
  • Scoring 2 or more on a test that measures feeling restless or unable to sit still (Barnes Akathisia Rating Scale).
  • Scoring 50 or more on a questionnaire that evaluates overall mental health symptoms (Brief Psychiatric Rating Scale).
  • Being hospitalized for schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder (MDD) within the last six months.
  • Having a medical condition that is not stable or a chronic disease that is currently getting worse.
  • Having any past history of neuroleptic malignant syndrome, a serious reaction to certain psychiatric medicines.
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Investigated drugs

NBI-1065890 is an experimental medicine being tested as a possible treatment for tardive dyskinesia, a movement disorder that can occur after long‑term use of certain drugs. In this study participants take the medicine in a hard gelatin capsule taken by mouth. Researchers are looking to see if the drug can reduce the involuntary movements, and they are also monitoring how safe and well‑tolerated it is compared with a placebo.

What is already known about the treatment

  • Matching Placebo Powder in Capsule

    This medication is taken by mouth as a hard gelatin capsule that contains only inactive powder, and it is used to mimic the appearance of the active drug in the study. It has no therapeutic effect and is not approved for any medical condition outside of clinical trials. The placebo serves as a control to help researchers compare the true effects of the test drug. Its classification is simply an inert placebo used for research purposes.

  • NBI-1065890

    NBI-1065890 is administered orally in a hard gelatin capsule and is being tested in this Phase 2 trial for adults with tardive dyskinesia. It is an experimental compound that is not yet approved and is currently only described in early‑stage medical literature. The drug is thought to work by modulating dopamine signaling in the brain, which may help reduce involuntary movements associated with the disorder. It is classified as an investigational dopamine‑modulating agent.

Investigated diseases

Tardive Dyskinesia - Tardive dyskinesia is a movement disorder that develops after prolonged exposure to certain dopamine‑blocking drugs. It is characterized by repetitive, involuntary movements, most often affecting the lips, tongue, and facial muscles. Over time, the movements can spread to the arms, legs, and trunk. The abnormal movements may become more frequent or intense with continued medication use. Even after the triggering drug is stopped, the movements can persist and may change slowly over months or years.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-524104-30-00Protocol codeNBI-1065890-TD2033Estimated enrolment123 patientsSponsorNeurocrine Biosciences Inc.

sourced from the EU Clinical Trials Register and site verification

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