Study of the Effectiveness of Valbenazine on Patient- and Clinician-Reported Outcomes in Participants With Tardive Dyskinesia

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About the study

This study will evaluate the effectiveness of valbenazine on patient- and clinician-reported outcomes assessing health-related quality of life, functioning, and treatment effect in participants with tardive dyskinesia (TD) who are receiving valbenazine for up to 24 weeks.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Key Inclusion Criteria:


  1. At least 18 years of age
  2. Have one of the following clinical diagnoses: schizophrenia or schizoaffective disorder, bipolar disorder, or major depressive disorder
  3. Have a clinical diagnosis of neuroleptic-induced TD
  4. Medication(s) for schizophrenia or schizoaffective disorder, bipolar disorder, or major depressive disorder and other protocol-allowed concurrent medications must be at a stable dose and expected to remain stable during the study
  5. Participants must be outpatients and have a stable psychiatric status

EXCLUSION CRITERIA

Key Exclusion Criteria:


  1. Have comorbid abnormal involuntary movement(s) (for example, Parkinsonism, akathisia) that is more prominent than TD
  2. Have an active, clinically significant unstable medical condition in the judgement of the investigator, or have any laboratory value outside the normal range that is considered by the investigator to be clinically significant at the screening visit

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 877-641-3461Email iconEmail Study Center

Study Details


Contition
Schizophrenia,Schizoaffective Disorder,Bipolar Disorder,Major Depressive Disorder,Tardive Dyskinesia
Age (in years)
18+
Phase
PHASE4
Participants Needed
59
Est. Completion Date
Dec 27, 2024
Treatment Type
INTERVENTIONAL

Sponsor
Neurocrine Biosciences
ClinicalTrials.gov NCT Identifier
NCT05859698
Study Number
NBI-98854-TD4020

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