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Compares treatment options for Tardive Dyskinesia
Official title Efficacy, Safety, and Tolerability of NBI-1065890 Versus Placebo in Adults With Tardive Dyskinesia
ClinicalTrials.gov ID: NCT07365462
What this study is testing
What is NBI-1065890?
NBI-1065890 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for tardive dyskinesia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Medically confirmed diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder (MDD) as defined in the...
- 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...
You likely can't join if
- Comorbid parkinsonism (drug-induced or otherwise) or more than a minimal level of extrapyramidal signs/symptoms, as documented by a score on the...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bryant, Arkansas, United States
- Chino, California, United States
- Fountain Valley, California, United States
- Huntington Beach, California, United States
- Long Beach, California, United States
- Temecula, California, United States
- Torrance, California, United States
- Boca Raton, Florida, United States
- Bonita Springs, Florida, United States
- Hialeah, Florida, United States
- Miami, Florida, United States
- Orange City, Florida, United States
- Tampa, Florida, United States
- Marietta, Georgia, United States
- Lincoln, Nebraska, United States
- Beachwood, Ohio, United States
- Fort Worth, Texas, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bryant, Arkansas, United States; Chino, California, United States; Fountain Valley, California, United States; Huntington Beach, California, United States; Long Beach, California, United States; Temecula, California, United States and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.