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Tardive DyskinesiaPhase 3Kinect 4NCT02405091

Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive Dyskinesia

A Phase 3 study testing NBI-98854 in people with Tardive Dyskinesia, run by Neurocrine Biosciences at 48 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Phase 3, open-label, study to evaluate the safety and tolerability of NBI-98854 administered once daily (qd) for a total of 48 weeks of treatment. This study will enroll approximately 150 medically stable male and female subjects with clinical diagnoses of schizophrenia or schizoaffective disorder with… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Tardive Dyskinesia
What is being tested?
NBI-98854
Could I receive a placebo?
No, everyone receives an active treatment
How many people
167 participants
Where
48 sitesin 3 countries
Study dates
Mar 2015to Mar 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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.
  • Female subjects must not be pregnant.
  • Have one of the following clinical diagnoses for at least 3 months prior to screening: Schizophrenia or Schizoaffective Disorder, or Mood Disorder
  • Have a clinical diagnosis of neuroleptic-induced TD for at least 3 months prior to screening.
  • Have moderate or severe TD
  • If using maintenance medication(s) for schizophrenia or schizoaffective disorder, or mood disorder, be on stable doses.
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  • Be in general good health.
  • Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.
  • Have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids.

Who cannot join

  • Have an active, clinically significant unstable medical condition within 1 month prior to screening.
  • Have a known history of substance dependence, substance (drug) or alcohol abuse.
  • Have a significant risk of suicidal or violent behavior.
  • Have a known history of neuroleptic malignant syndrome.
  • Have a known history of long QT syndrome or cardiac tachy-arrhythmia.
  • Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed).
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  • Have received an investigational drug within 30 days before screening 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 tetrabenazine.
  • Are currently pregnant or breastfeeding.

Trial locations and contacts

48 sites in 3 countries.

48 sites in 3 countries

United States43 sites

  • Study site

    Anaheim, California

  • Study site

    Ann Arbor, Michigan

  • Study site

    Bradenton, Florida

  • Study site

    Buffalo, New York

  • Study site

    Chicago, Illinois

  • Study site

    Conshohocken, Pennsylvania

  • Study site

    Dayton, Ohio

  • Study site

    DeSoto, Texas

  • Study site

    Fort Worth, Texas

  • Study site

    Glendale, California

  • Study site

    Hialeah, Florida

  • Study site

    High Point, North Carolina

  • Study site

    Hockessin, Delaware

  • Study site

    Honolulu, Hawaii

  • Study site

    Houston, Texas

  • Study site

    Irvine, California

  • Study site

    Irving, Texas

  • Study site

    Kissimmee, Florida

  • Study site

    Lincoln, Nebraska

  • Study site

    Long Beach, California

  • Study site

    Los Angeles, California

  • Study site

    Miami, Florida

  • Study site

    Nashua, New Hampshire

  • Study site

    Natick, Massachusetts

  • Study site

    New York, New York

  • Study site

    Norristown, Pennsylvania

  • Study site

    North Miami, Florida

  • Study site

    Oakland, California

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Omaha, Nebraska

  • Study site

    Orlando, Florida

  • Study site

    Petersburg, Virginia

  • Study site

    Phoenixville, Pennsylvania

  • Study site

    Rochester, New York

  • Study site

    San Bernardino, California

  • Study site

    San Diego, California

  • Study site

    Scranton, Pennsylvania

  • Study site

    Seattle, Washington

  • Study site

    Shreveport, Louisiana

  • Study site

    Spokane, Washington

  • Study site

    St Louis, Missouri

  • Study site

    Torrance, California

  • Study site

    Worcester, Massachusetts

Other trials in United States

Canada4 sites

  • Study site

    London, Ontario

  • Study site

    Montreal, Quebec

  • Study site

    Toronto, Ontario

  • Study site

    Vancouver, British Columbia

Other trials in Canada

Puerto Rico1 site

  • Study site

    San Juan

Other trials in Puerto Rico

About this study

Official title: A Phase 3, Open-Label, Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive Dyskinesia

Phase 3, open-label, study to evaluate the safety and tolerability of NBI-98854 administered once daily (qd) for a total of 48 weeks of treatment. This study will enroll approximately 150 medically stable male and female subjects with clinical diagnoses of schizophrenia or schizoaffective disorder with neuroleptic-induced TD or mood disorder with neuroleptic-induced TD.

Being tested
NBI-98854
Medical subject headings
Tardive Dyskinesia

What participants receive

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

  • NBI-98854Drug

Study groups in NCT02405091
Study groupRoleWhat they receive
Dose Group 1ExperimentalFixed dose of NBI-98854 administered once daily for 48 weeks
Receives: Drug: NBI-98854
Dose Group 2ExperimentalFixed dose of NBI-98854 administered once daily up to 48 weeks
Receives: Drug: NBI-98854

What is being measured

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

  1. Number of Participants Monitored for Long-Term Safety of Valbenazine

    Number of participants monitored for long-term safety through reporting of treatment-emergent adverse events and monitoring of vital signs, clinical laboratory values, and ECG. Summaries of all treatment-emergent AEs, treatment-related AEs, SAEs, and AEs leading to study drug discontinuation were prepared.

    Measured: 52 weeks

Secondary outcomes (4)

  1. Severity of Tardive Dyskinesia (TD) Symptoms Assessed by Abnormal Involuntary Movements Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 48; On-site AIMS Raters

    Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by On-Site AIMS video raters. The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.

    Measured: Baseline and Week 48

  2. Severity of Tardive Dyskinesia (TD) Symptoms Assessed by Abnormal Involuntary Movements Scale (AIMS) Dyskinesia Total Score Change From Baseline; Central AIMS Video Raters

    Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by the blinded, Central AIMS Video Raters. The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.

    Measured: Baseline, Change from Baseline at Week 8, and Change from Baseline at Week 52

  3. Severity of Tardive Dyskinesia (TD) Symptoms Assessed by Abnormal Involuntary Movements Scale (AIMS) Dyskinesia Total Score Change From Baseline; On-Site AIMS Raters

    Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by On-Site AIMS raters. The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.

    Measured: Baseline, Change from Baseline at Week 8, and Change from Baseline at Week 52

  4. Clinical Global Impression - Global Improvement of Tardive Dyskinesia (CGI-TD) at Week 48

    Clinician's perspective of the participant's overall improvement of TD symptoms since initiation of study drug dosing. The CGI-TD is based on a 7-point scale (range: 1=very much improved to 7=very much worse).

    Measured: Week 48

Timeline

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

  1. First posted1 Apr 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionMar 2017
  4. Study completionMar 2017

Resources

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 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
167 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02405091
Sponsor's protocol ID
NBI-98854-1402
Acronym
Kinect 4
Status last verified
Nov 2018
First submitted
27 Mar 2015
Last updated
30 Nov 2018
Data monitoring committee
No

Publications

  • Sajatovic M, Alexopoulos GS, Jen E, Farahmand K, Zinger C. Improvements Over Time with Valbenazine in Elderly Adults (>/=65 Years) with Tardive Dyskinesia: Post Hoc Analyses of 2 Long-Term Studies. J Clin Psychiatry. 2025 Apr 23;86(2):24m15550. doi: 10.4088/JCP.24m15550.

    PubMed 40265997

  • Sajatovic M, Alexopoulos GS, Burke J, Farahmand K, Siegert S. The effects of valbenazine on tardive dyskinesia in older and younger patients. Int J Geriatr Psychiatry. 2020 Jan;35(1):69-79. doi: 10.1002/gps.5218. Epub 2019 Oct 31.

    PubMed 31617235

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NBI-98854 in people with Tardive Dyskinesia, run by Neurocrine Biosciences at 48 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in United States, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Monitored for Long-Term Safety of Valbenazine (time frame: 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02405091, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2018.

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