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โ† Trials
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Efficacy, Safety, and Tolerability of NBI-1065890 Versus Placebo in Adults With Tardive Dyskinesia

RecruitingPhase 2Ages 18 Years - 75 YearsAllNeurocrine Biosciences
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In plain words

What the trial is, and whether it could suit you

The primary objective of this study is to evaluate the efficacy of NBI-1065890 compared with placebo for the treatment of tardive dyskinesia (TD) in adult participants.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ6 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 โ‰ฅ2 at screening or Day -1. * Brief Psychiatric Rating Scale (BPRS) total score โ‰ฅ50 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.
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What it tests

  • NBI-1065890
  • Placebo
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Where

18 sites
Neurocrine Clinical Site
Bryant, United States
Neurocrine Clinical Site
Chino, United States
Neurocrine Clinical Site
Fountain Valley, United States
Neurocrine Clinical Site
Huntington Beach, United States
Neurocrine Clinical Site
Long Beach, United States
Neurocrine Clinical Site
Temecula, United States
Neurocrine Clinical Site
Torrance, United States
Neurocrine Clinical Site
Boca Raton, United States

โ€ฆand 10 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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