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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

18 sites in 1 country.

About this study

Official title: A Phase 4, Single-Arm, Open-Label Study to Evaluate the Effectiveness of Valbenazine on Patient- and Clinician-Reported Outcomes in Subjects With Tardive Dyskinesia

Conditions

Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Major Depressive Disorder, Tardive Dyskinesia

Being tested

Valbenazine

Medical subject headings

Schizophrenia, Psychotic Disorders, Bipolar Disorder, Depressive Disorder, Major, Tardive Dyskinesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• ValbenazineDrug

  Also called NBI-98854

  Valbenazine capsules for oral administration

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Change From Baseline in the Tardive Dyskinesia Impact Scale (TDIS) Total Score at Week 24

   The TDIS assesses the impact of impairment and disability associated with dyskinesia. It defines impact of tardive dyskinesia (TD) in terms of 6 scales: Mouth/Throat Function (3 items), Dexterity (2 items), Mobility (2 items), Pain (1 item), Emotional (2 items), and Social (1 item). Each item measured the impact of dyskinetic movements in terms of difficulty or frequency over the last 7 days on a 5-point scale, with scores ranging from 0 to 4. Response options for the difficulty items ranged from not at all (0) to extremely (4); those for the frequency items ranged from never (0) to all of the time (4). The TDIS total score was the sum of the scores of TDIS Items 1 to 11. Total scores ranged from 0 to 44, with higher scores representing greater TD impact.

   Measured: Baseline, Week 24

2. Change From Baseline in the Sheehan Disability Scale (SDS) Items 1, 2, and 3 Score at Week 24

   The SDS included 3 self-rated items designed to measure how work, social life, and family life are impaired by current psychiatric symptoms. Each item includes an 11-point analog scale that uses visual-spatial, numeric, and verbal descriptive anchors to represent the degree of disruption from 0 (none at all) to 10 (extremely). Participants who had not worked for pay or attended school in the previous 7 days for reasons unrelated to TD did not respond to Item 1 and were therefore excluded from the analysis of that item.

   Measured: Baseline, Week 24

3. Change From Baseline in the Euro Quality of Life Visual Analogue Scale (EQ-VAS) Score at Week 24

   Participants rated their overall health on a 0 to 100 hash-marked, vertical EQ-VAS where 0 represents 'The worst health you can imagine' and 100 represents 'The best health you can imagine.' An increase from baseline indicates an increase in overall health.

   Measured: Baseline, Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted16 May 2023
2. Study start9 May 2023
3. Primary completion27 Dec 2024
4. Study completion27 Dec 2024

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Other trials for SchizophreniaStudies of the same condition, open and under way.
• More trials run by Neurocrine BiosciencesThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.