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Tardive DyskinesiaPhase 3KINECT 3NCT02274558

A Phase 3 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 54 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

The purpose of this study is to evaluate the efficacy, safety, and tolerability of NBI-98854 administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms. 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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
234 participants
Where
54 sitesin 3 countries
Study dates
Oct 2014to Jul 2016
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.
Show all 9Show fewer
  • Be in good general health.
  • Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.
  • Have a negative drug screen for amphetamines,barbiturates, benzodiazepines, 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, or 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 of screening (some exceptions allowed)
Show all 11Show fewer
  • Have received an investigational drug within 30 days prior to 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.
  • Have had previous exposure with NBI-98854 or had previously participated in an NBI-98854 clinical study.
  • Are currently pregnant or breastfeeding.

Trial locations and contacts

54 sites in 3 countries.

54 sites in 3 countries

United States48 sites

  • Study site

    Amherst, New York

  • Study site

    Anaheim, California

  • Study site

    Baltimore, Maryland

  • Study site

    Bradenton, Florida

  • Study site

    Cedarhurst, New York

  • Study site

    Charleston, South Carolina

  • Study site

    Chicago, Illinois

  • Study site

    Conshohocken, Pennsylvania

  • Study site

    Dayton, Ohio

  • Study site

    DeSoto, Texas

  • Study site

    Durham, North Carolina

  • Study site

    Flowood, Mississippi

  • Study site

    Fort Worth, Texas

  • Study site

    Glen Burnie, Maryland

  • Study site

    Glendale, California

  • Study site

    Hialeah, Florida

  • Study site

    Irvine, California

  • Study site

    Irving, Texas

  • Study site

    Kissimmee, Florida

  • Study site

    Leesburg, Florida

  • Study site

    Lincoln, Nebraska

  • Study site

    Little Rock, Arkansas

  • Study site

    Long Beach, California

  • Study site

    Los Angeles, California

  • Study site

    Maitland, Florida

  • Study site

    Memphis, Tennessee

  • Study site

    Miami, Florida

  • Study site

    National City, California

  • Study site

    Norristown, Pennsylvania

  • Study site

    North Miami, Florida

  • Study site

    Norwalk, California

  • Study site

    Oak Brook, Illinois

  • Study site

    Oakland, California

  • Study site

    Oceanside, California

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Petersburg, Virginia

  • Study site

    Phoenixville, Pennsylvania

  • Study site

    Pinehurst, North Carolina

  • Study site

    Rochester, New York

  • Study site

    San Bernardino, California

  • Study site

    San Diego, California

  • Study site

    Scranton, Pennsylvania

  • Study site

    Shaker Heights, Ohio

  • 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 Rico2 sites

  • Study site

    Caguas

  • Study site

    San Juan

Other trials in Puerto Rico

About this study

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel, Fixed-Dose Study to Assess the Efficacy, Safety, and Tolerability of NBI-98854 for the Treatment of Tardive Dyskinesia

The purpose of this study is to evaluate the efficacy, safety, and tolerability of NBI-98854 administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.

Read the detailed description

This is a Phase 3, randomized, double-blind, placebo-controlled, parallel, fixed-dose study to evaluate the efficacy, safety, and tolerability of two doses of NBI-98854 (40 mg and 80 mg) compared to placebo, administered once daily. The study design includes a double-blind, placebo-controlled treatment period for 6 weeks and a double-blind NBI-98854 treatment period for an additional 42 weeks, for a total of 48 weeks of treatment. Final follow-up assessments will be conducted 4 weeks after the last dose of the study drug.

Being tested
NBI-98854, Placebo
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

    NBI-98854 40 mg capsules

  • PlaceboDrug

    NBI-98854 placebo capsules

Study groups in NCT02274558
Study groupRoleWhat they receive
NBI-98854 40 mgExperimentalNBI-98854 administered as one (1) 40 mg capsule and one (1) placebo capsule, taken by mouth, every morning between 7:00am - 10:00am for 6 weeks. At the end of Week 6, subjects will enter a double-blind NBI-98854 treatment period and continue with their current dose.
Receives: Drug: NBI-98854; Drug: Placebo
NBI-98854 80 mgExperimentalSubjects randomized to the NBI-98854 80 mg dose will receive NBI-98854 40 mg for the first week (administered as one (1) 40 mg capsule and one (1) placebo capsule), followed by NBI-98854 80 mg administered as two (2) 40 mg capsules, taken by mouth, every morning between 7:00am - 10:00am for 5 weeks. At the end of Week 6, subjects will enter a double-blind NBI-98854 treatment period and continue with their current dose.
Receives: Drug: NBI-98854; Drug: Placebo
PlaceboExperimentalPlacebo administered as two (2) placebo capsules, taken by mouth, every morning between 7:00am - 10:00am for 6 weeks. At the end of Week 6, subjects will enter a double-blind NBI-98854 treatment period and be randomized to either a 40 mg or 80 mg dose. Subjects re-randomized to receive NBI-98854 80 mg will receive 40 mg for the first week.
Receives: Drug: NBI-98854; Drug: Placebo

What is being measured

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

  1. Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 6

    Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by 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 and Week 6

Secondary outcomes (2)

  1. Clinical Global Impression of Change - TD (CGI-TD) at Week 6

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

    Measured: Week 6

  2. Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Responder Analysis at Week 6

    Percentage of AIMS responders (subjects who had at least a 50 percent reduction in AIMS score from baseline)

    Measured: Week 6

Timeline

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

  1. First posted24 Oct 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionSep 2015
  4. Study completionJul 2016

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
234 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02274558
Sponsor's protocol ID
NBI-98854-1304
Acronym
KINECT 3
Status last verified
Jun 2017
First submitted
22 Oct 2014
Last updated
11 Jul 2017
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

  • Correll CU, Cutler AJ, Kane JM, McEvoy JP, Liang GS, O'Brien CF. Characterizing Treatment Effects of Valbenazine for Tardive Dyskinesia: Additional Results From the KINECT 3 Study. J Clin Psychiatry. 2018 Dec 18;80(1):18m12278. doi: 10.4088/JCP.18m12278.

    PubMed 30695293

  • Factor SA, Remington G, Comella CL, Correll CU, Burke J, Jimenez R, Liang GS, O'Brien CF. The Effects of Valbenazine in Participants with Tardive Dyskinesia: Results of the 1-Year KINECT 3 Extension Study. J Clin Psychiatry. 2017 Nov/Dec;78(9):1344-1350. doi: 10.4088/JCP.17m11777.

    PubMed 29141124

  • Grigoriadis DE, Smith E, Hoare SRJ, Madan A, Bozigian H. Pharmacologic Characterization of Valbenazine (NBI-98854) and Its Metabolites. J Pharmacol Exp Ther. 2017 Jun;361(3):454-461. doi: 10.1124/jpet.116.239160. Epub 2017 Apr 12.

    PubMed 28404690

  • Hauser RA, Factor SA, Marder SR, Knesevich MA, Ramirez PM, Jimenez R, Burke J, Liang GS, O'Brien CF. KINECT 3: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Valbenazine for Tardive Dyskinesia. Am J Psychiatry. 2017 May 1;174(5):476-484. doi: 10.1176/appi.ajp.2017.16091037. Epub 2017 Mar 21.

    PubMed 28320223

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 54 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 11 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 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 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 11 Jul 2017). 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?

Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 6 (time frame: Baseline and Week 6). 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 NCT02274558, which also lists 6 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 11 Jul 2017.

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