In short
NBI-1065890 is an investigational medicine being studied for tardive dyskinesia, a condition that causes uncontrollable movements. It is currently in Phase 2 clinical research. One clinical trial, NCT07365462, plans to enroll 123 adults to compare NBI-1065890 with a placebo. The study is authorised but not yet recruiting.
Key points
- NBI-1065890 is an investigational medicine, not yet approved for use.
- It is being studied in a Phase 2 trial for tardive dyskinesia.
- The trial will compare NBI-1065890 with a placebo in 123 adults.
- The main measurement is the change in the Abnormal Involuntary Movement Scale (AIMS) score after 8 weeks.
- The study is currently authorised, meaning it can begin enrolling participants.
What is NBI-1065890?
NBI-1065890 is an investigational medicine, which means it has not yet received marketing authorisation and is still being studied in clinical trials. The full name of the substance is NBI-1065890. It is being developed as a potential treatment for tardive dyskinesia, a movement disorder.
How does NBI-1065890 work?
The available trial record does not describe the mechanism of action of NBI-1065890. The study is designed to evaluate its efficacy, safety, and tolerability in adults with tardive dyskinesia, but the precise way the substance works has not been stated in the provided data.
Which conditions is NBI-1065890 studied for?
- Tardive dyskinesia: a condition that causes uncontrollable, repetitive movements, often of the face, lips, tongue, or limbs. NBI-1065890 is being studied to see whether it can reduce these movements.
How is NBI-1065890 given?
In the clinical trial, NBI-1065890 is given as a powder in a capsule for oral use. The trial record lists the dose as 0 mg, which means the dose was not reported in the register. The comparison group receives a matching placebo powder in a capsule.
What do the clinical trials show?
One clinical trial, NCT07365462, is investigating NBI-1065890. It is a Phase 2 study in adults with tardive dyskinesia. The trial is authorised, meaning it has received the necessary approvals to begin, and it plans to enroll 123 participants. The study compares NBI-1065890 with a placebo.
The main outcome the trial measures is the change from baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score at Week 8, based on the assessment of blinded central AIMS video raters. The AIMS is a scale used to rate the severity of abnormal movements. The trial includes adults with tardive dyskinesia, but the record does not provide further details on who can take part.
What side effects are known?
No side effects for NBI-1065890 are described in the provided data. The clinical trial is designed to evaluate safety and tolerability, but no specific side effects have been reported in the sources available for this page.