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A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor

ConditionsSchizophreniaSchizoaffective DisorderBipolar DisorderMajor Depressive DisorderTardive Dyskinesia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorNeurocrine Biosciences

About this trial

This study will evaluate the efficacy of valbenazine on clinician- and patient-reported outcomes in participants with TD while receiving or after stopping a VMAT2 inhibitor.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years of age or older

Diagnosed with one of the following at least 3 months prior to screening: schizophrenia or schizoaffective disorder, bipolar disorder, or major depressive disorder

Diagnosed with at least mild neuroleptic-induced TD for at least 3 months prior to screening

Disqualifiers

Have comorbid Parkinsonism or abnormal involuntary movement(s) that is more prominent than TD

Diagnosis of moderate or severe substance use disorder in the last 6 months

History of long QT syndrome, cardiac arrythmia, or severe hepatic impairment

Trial design

Design model

Single group

Treatments tested in this trial

  • Valbenazine

    Drug

    Valbenazine capsules for oral administration.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: ValbenazineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score (AIMS 1-7) at Week 24

Time frame
Baseline, Week 24

Secondary outcomes

1

Change from Baseline in the Clinical Global Impression of Severity - Tardive Dyskinesia (CGI-TD-S) Score at Week 24

Time frame
Baseline, Week 24
2

Change from Baseline in the Tardive Dyskinesia Impact Scale (TDIS) at Week 24

Time frame
Baseline, Week 24
3

Change from Baseline in the EuroQol-Visual Analogue Scale (EQ-VAS) at Week 24

Time frame
Baseline, Week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Neurocrine Biosciences

Lead sponsor

Source ClinicalTrials.gov
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