NBI-1065890 versus placebo for adults with tardive dyskinesia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial compares the investigational drug NBI-1065890 to placebo in adults who have neuroleptic-induced tardive dyskinesia and a qualifying psychiatric diagnosis. Participants must have had TD for at least three months and meet a minimum severity threshold on the AIMS dyskinesia total score as confirmed by a blinded external video reviewer. Dosing is compared against placebo while blinded certified site raters and external reviewers use AIMS video assessments to measure changes in abnormal movements; safety and tolerability are also monitored. The study is being conducted at Neurocrine Clinical Sites in California and Florida.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Medically confirmed diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder (MDD) as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) for at least 3 months prior to screening.
* Medically confirmed diagnosis of neuroleptic-induced TD as defined in the DSM-5 for at least 3 months prior to screening.
* Moderate or severe TD (AIMS Item 8, severity of abnormal movement overall) as assessed by a blinded, external AIMS video reviewer using a video recording of the participant's AIMS assessment administered at the clinical site by a blinded, certified site AIMS rater. The AIMS dyskinesia total score (sum of Items 1 to 7) must be ≥6 as assessed by the blinded, external AIMS video reviewer.

Key Exclusion Criteria:

* Comorbid parkinsonism (drug-induced or otherwise) or more than a minimal level of extrapyramidal signs/symptoms, as documented by a score on the Modified Simpson-Angus Scale (mSAS) (excluding Items 8 and 10) \>6 at screening or Day -1 (baseline) or a score \>3 in any one item (excluding Items 8 and 10).
* Barnes Akathisia Rating Scale (BARS) global clinical assessment score ≥2 at screening or Day -1.
* Brief Psychiatric Rating Scale (BPRS) total score ≥50 at screening or Day -1.
* Hospitalized for schizophrenia, schizoaffective disorder, bipolar disorder, or MDD within 6 months of screening.
* Participant has an unstable medical condition or unstable chronic disease.
* Any known history of neuroleptic malignant syndrome (NMS).

Note: Other protocol-defined inclusion and exclusion criteria may apply.

Where it's running

• Neurocrine Clinical Site
  Bryant, Arkansas, United States Recruiting
• Neurocrine Clinical Site
  Chino, California, United States Recruiting
• Neurocrine Clinical Site
  Fountain Valley, California, United States Recruiting
• Neurocrine Clinical Site
  Huntington Beach, California, United States Recruiting
• Neurocrine Clinical Site
  Long Beach, California, United States Recruiting
• Neurocrine Clinical Site
  Temecula, California, United States Recruiting

Study contacts

• Study coordinator: Neurocrine Medical Information Call Center
• Email: medinfo@neurocrine.com
• Phone: 1-877-641-3461

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Precise-target rTMS to relieve motor symptoms of tardive dyskinesia

  This trial will try targeted repetitive transcranial magnetic stimulation (rTMS) to reduce involuntary movements in adults with tardive dyskinesia.

  Recruiting Peking University Sixth Hospital · Beijing · NCT07173920

• Valbenazine for adults with tardive dyskinesia who remain symptomatic on or after a VMAT2 inhibitor

  This trial will test whether valbenazine reduces involuntary movements in adults with tardive dyskinesia who still have symptoms while taking or after stopping a VMAT2 inhibitor.

  Recruiting at 19 sites Phase 4 Neurocrine Biosciences · Bryant, Arkansas and 18 other locations · NCT07105111

• Deutetrabenazine for Tardive Dyskinesia in IDD

  This study tests whether deutetrabenazine helps reduce tardive dyskinesia in people with intellectual and developmental disabilities who have not previously received this treatment.

  Recruiting Phase 4 University Hospitals Cleveland Medical Center · Cleveland, Ohio · NCT06997198

• Smoking cessation treatment for schizophrenia patients using varenicline

  This study is testing if the smoking cessation drug varenicline can help people with schizophrenia quit smoking while also managing their movement side effects from antipsychotic medications.

  Recruiting Phase 4 Corporal Michael J. Crescenz VA Medical Center · Philadelphia, Pennsylvania · NCT03495024

• Evaluating a new medication for tardive dyskinesia

  This study is testing a new medication for tardive dyskinesia to see if it helps people aged 18 to 65 who have had symptoms from their medication for at least three months.

  Recruiting Phase 1/2 Luye Pharma Group Ltd. · Shanghai · NCT06731868

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.