Tardive Dyskinesia (TD)Phase 4NCT03891862
Persistence of Effect and Safety of Valbenazine for the Treatment of Tardive Dyskinesia
A Phase 4 study testing Valbenazine in people with Tardive Dyskinesia (TD), run by Neurocrine Biosciences at 43 sites in 2 countries.
Trial summary
This is a Phase 4, randomized, double-blind, placebo-controlled study to evaluate the persistence of effect of valbenazine 40 mg and 80 mg. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Tardive Dyskinesia (TD)
- What is being tested?
- Valbenazine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 43 sitesin 2 countries
- Study dates
- 18 Mar 2019to 30 Jan 2020
- Phase
- Phase 4
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects of childbearing potential must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment, and follow-up periods of the study.
- Have one of the following clinical diagnoses for at least 3 months before screening: Schizophrenia, Schizoaffective Disorder, or Mood Disorder
- Have a clinical diagnosis of neuroleptic-induced TD for at least 3 months before screening.
- Be on stable doses if using maintenance medication(s) for schizophrenia or schizoaffective disorder, or mood disorder. Subjects with bipolar disorder must be on stable doses of a mood stabilizer.
- Be in general good health.
- Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.
Who cannot join
- Have an active, clinically significant unstable medical condition within 1 month before screening.
- Have a known history of substance (drug) dependence, or substance or alcohol abuse.
- Have a significant risk of suicidal or violent behavior.
- Have been hospitalized for psychiatric disorder within 6 months before Day 1.
- Have a known history of neuroleptic malignant syndrome.
- Have a known history of long QT syndrome or cardiac arrhythmia.
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- Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed).
- Are currently taking tetrabenazine or deutetrabenazine, or have used valbenazine (INGREZA) within 30 days of screening.
- Have received an investigational drug within 30 days before Day 1 or plan to use an investigational drug (other than NBI-98854) during the study.
- Have a blood loss ≥550 mL or donated blood within 30 days prior to Baseline.
- Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors (eg, tetrabenazine, deutetrabenazine).
- Are currently pregnant or breastfeeding.
- Have HIV or hepatitis B.
Trial locations and contacts
43 sites in 2 countries.
43 sites in 2 countries
United States42 sites
Neurocrine Clinical Site
Anaheim, California, 92804
Neurocrine Clinical Site
Anaheim, California, 92805
Neurocrine Clinical Site
Beachwood, Ohio, 44122
Neurocrine Clinical Site
Bloomfield Hills, Michigan, 48302
Neurocrine Clinical Site
Conshohocken, Pennsylvania, 19428
Neurocrine Clinical Site
Costa Mesa, California, 92627
Neurocrine Clinical Site
DeSoto, Texas, 75115
Neurocrine Clinical Site
East Lansing, Michigan, 48824
Neurocrine Clinical Site
Escondido, California, 92056
Neurocrine Clinical Site
Fountain Valley, California, 92708
Neurocrine Clinical Site
Franklin, Tennessee, 37067
Neurocrine Clinical Site
Glendale, California, 91206
Neurocrine Clinical Site
Grand Rapids, Michigan, 49503
Neurocrine Clinical Site
Hialeah, Florida, 33012
Neurocrine Clinical Site
Hialeah, Florida, 33013
Neurocrine Clinical Site
Hialeah, Florida, 33018
Neurocrine Clinical Site
Houston, Texas, 44030
Neurocrine Clinical Site
Houston, Texas, 77058
Neurocrine Clinical Site
Irving, Texas, 75062
Neurocrine Clinical Site
Kansas City, Missouri, 64108
Neurocrine Clinical Site
La Habra, California, 90631
Neurocrine Clinical Site
Las Vegas, Nevada, 89102
Neurocrine Clinical Site
Lemon Grove, California, 91945
Neurocrine Clinical Site
Lincoln, Nebraska, 68526
Neurocrine Clinical Site
Little Rock, Arkansas, 72211
Neurocrine Clinical Site
Mason, Ohio, 45040
Neurocrine Clinical Site
Miami, Florida, 33183
Neurocrine Clinical Site
New York, New York, 10029
Neurocrine Clinical Site
North Miami, Florida, 33161
Neurocrine Clinical Site
Norwalk, California, 90650
Neurocrine Clinical Site
Oklahoma City, Oklahoma, 73112
Neurocrine Clinical Site
Orlando, Florida, 32803
Neurocrine Clinical Site
Petersburg, Virginia, 23805
Neurocrine Clinical Site
Pueblo, Colorado, 81003
Neurocrine Clinical Site
Richmond, Texas, 77407
Neurocrine Clinical Site
San Bernardino, California, 92408
Neurocrine Clinical Site
San Diego, California, 92108
Neurocrine Clinical Site
Scranton, Pennsylvania, 18503
Neurocrine Clinical Site
South Bend, Indiana, 46601
Neurocrine Clinical Site
Spokane, Washington, 99202
Neurocrine Clinical Site
St Louis, Missouri, 63109
Neurocrine Clinical Site
Torrance, California, 90502
About this study
Official title: A Phase 4, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Evaluate the Persistence of Effect and Safety of Valbenazine for the Treatment of Tardive Dyskinesia
This is a Phase 4, randomized, double-blind, placebo-controlled study to evaluate the persistence of effect of valbenazine 40 mg and 80 mg.
- Conditions
- Tardive Dyskinesia (TD)
- Being tested
- Valbenazine, Placebo oral capsule
- Medical subject headings
- Tardive Dyskinesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValbenazineDrug
Also called Ingrezza, NBI-98854
vesicular monoamine transporter 2 (VMAT2) inhibitor
Placebo oral capsuleDrug
non-active dosage form
| Study group | Role | What they receive |
|---|---|---|
| Open-label Valbenazine | Experimental | Participants received valbenazine 40 mg once daily for 1 week, then 80 mg once daily for the remainder of the 8-week open label period. Receives: Drug: Valbenazine |
| Placebo-controlled Placebo | Placebo comparator | Participants received placebo (matching valbenazine) once daily for 8 weeks. Randomization into this arm occurred after open-label treatment with valbenazine once daily for 8 weeks. Receives: Drug: Placebo oral capsule |
| Placebo-controlled Valbenazine | Experimental | Participants received valbenazine 80 mg once daily for 8 weeks. Randomization into this arm occurred after open-label treatment with valbenazine once daily for 8 weeks. Receives: Drug: Valbenazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Randomization (Week 8) in Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score at Week 16
The AIMS rates 10 items of involuntary movement, each item ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Items assess facial, oral, extremity, and trunk movements, as well as self-awareness of abnormal movements. The AIMS Dyskinesia Total Score is the sum of items 1-7 and ranges from 0 to 28, with higher scores indicating more severe dyskinesia. Least-squares mean were estimated using a mixed-effects model for repeated measures.
Measured: Week 8, Week 16
Secondary outcomes (2)
Change From Baseline in the EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) Health State Index Score at Week 16
The EQ-5D-5L assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The health state index score is based on the results of the individual health profiles using the United States value set and ranges from -0.573 to 1.0, with higher scores indicating higher health utility.
Measured: Baseline, Week 16
Change From Baseline in the EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) at Week 16
The EQ-5D-5L assesses general health-related quality of life. The second portion of the scale is a self-perceived health score assessed using a VAS that ranges from 0 ("the worst imaginable health") to 100 ("the best imaginable health").
Measured: Baseline, Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start18 Mar 2019
- Primary completion23 Dec 2019
- Study completion30 Jan 2020
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 Tardive Dyskinesia (TD)Studies 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.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurocrine Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study director, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03891862
- Sponsor's protocol ID
- NBI-98854-TD4002
- Status last verified
- Mar 2021
- First submitted
- 25 Mar 2019
- Last updated
- 20 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No