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Tardive DyskinesiaPhase 2NCT01688037

NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder (KINECT Study)

A Phase 2 study testing NBI-98854 in people with Tardive Dyskinesia, run by Neurocrine Biosciences at 51 sites in 2 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 two doses (50 and 100 mg) 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
109 participants
Where
51 sitesin 2 countries
Study dates
Sep 2012to Oct 2013
Phase
Phase 2
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

  • Have a clinical diagnosis of schizophrenia or schizoaffective disorder and a clinical diagnosis of neuroleptic-induced tardive dyskinesia for at least 3 months prior to screening.
  • Be receiving a stable dose of antipsychotic medication for a minimum of 30 days before study start. Subjects who are not using antipsychotic medication must have stable psychiatric status.
  • Have the doses of concurrent medications and the conditions being treated be stable for a minimum of 30 days before study start and be expected to remain stable during the study.
  • Subjects of childbearing potential must agree to use hormonal or two forms of nonhormonal birth control during the study.
  • Female subjects must not be pregnant.
  • Be in good general health and expected to complete the clinical study as designed.
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  • Have a body mass index (BMI) of 18 to 38 kg/m2 (both inclusive).
  • Have a negative urine drug screen (negative for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids) at screening and study start, except for any subject receiving a stable dose of benzodiazepine.
  • Have a negative alcohol breath test at screening and study start.

Who cannot join

  • Have an active clinically significant unstable medical condition within 1 month (30 days) prior to screening.
  • Have a history of substance dependence or substance (drug) or alcohol abuse within the 3 months before study start(nicotine and caffeine dependence are not exclusionary).
  • Have a known history of neuroleptic malignant syndrome.
  • Have a significant risk of suicidal or violent behavior.
  • Receiving any excluded concomitant medication such as reserpine, metoclopramide, stimulants, or tetrabenazine.
  • Receiving medication for the treatment of tardive dyskinesia.
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  • Have a positive human immunodeficiency virus antibody, (HIV-Ab), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody result at screening or have a history of positive result.
  • 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 an allergy, hypersensitivity, or intolerance to tetrabenazine.
  • Have had previous exposure with NBI-98854.

Trial locations and contacts

51 sites in 2 countries.

51 sites in 2 countries

United States49 sites

  • Study site

    Albany, New York, 12208

  • Study site

    Anaheim, California, 92804

  • Study site

    Atlanta, Georgia, 30342

  • Study site

    Baltimore, Maryland, 21285

  • Study site

    Beachwood, Ohio, 44122

  • Study site

    Bothell, Washington, 98011

  • Study site

    Brooklyn, New York, 11203

  • Study site

    Carson, California, 90746

  • Study site

    Charleston, South Carolina, 29407

  • Study site

    Chicago, Illinois, 60612

  • Study site

    Chicago, Illinois, 60640

  • Study site

    Colton, California, 92324

  • Study site

    Conshohocken, Pennsylvania, 19428

  • Study site

    Costa Mesa, California, 92626

  • Study site

    DeSoto, Texas, 75115

  • Study site

    Downey, California, 90241

  • Study site

    Fort Lauderdale, Florida, 33334

  • Study site

    Fountain Valley, California, 92708

  • Study site

    Glen Burnie, Maryland, 21061

  • Study site

    Glendale, California, 91206

  • Study site

    Hialeah, Florida, 33012

  • Study site

    Hope Mills, North Carolina, 28348

  • Study site

    Irving, Texas, 75062

  • Study site

    Kirkland, Washington, 98033

  • Study site

    Lauderhill, Florida, 33319

  • Study site

    Little Rock, Arkansas, 72211

  • Study site

    Melbourne, Florida, 32901

  • Study site

    Memphis, Tennessee, 38119

  • Study site

    Miami Springs, Florida, 33166

  • Study site

    National City, California, 91950

  • Study site

    New Orleans, Louisiana, 70114

  • Study site

    North Miami, Florida, 33161

  • Study site

    Oceanside, California, 92056

  • Study site

    Oklahoma City, Oklahoma, 73112

  • Study site

    Orange City, Florida, 32763

  • Study site

    Paramount, California, 90723

  • Study site

    San Bernardino, California, 92408

  • Study site

    San Diego, California, 92103

  • Study site

    San Diego, California, 92108

  • Study site

    San Diego, California, 92121

  • Study site

    San Diego, California, 92123

  • Study site

    Santa Ana, California, 92705

  • Study site

    Schaumburg, Illinois, 60194

  • Study site

    Shreveport, Louisiana, 71104

  • Study site

    Spokane, Washington, 99204

  • Study site

    St Louis, Missouri, 63118

  • Study site

    St Louis, Missouri, 63141

  • Study site

    Toms River, New Jersey, 08755

  • Study site

    Wards Island, New York, 10035

Other trials in United States

Puerto Rico2 sites

  • Study site

    Caguas, 00725

  • Study site

    San Juan, 00927

Other trials in Puerto Rico

About this study

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder

The purpose of this study is to evaluate the efficacy, safety, and tolerability of two doses (50 and 100 mg) of NBI-98854 administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.

Read the detailed description

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy, safety, and tolerability of two doses (50 and 100 mg) of NBI-98854 administered once daily for up to 2 weeks. The study will also allow for an evaluation of the efficacy of NBI-98854 50 mg once daily for up to 6 weeks and the safety and tolerability of NBI 98854 50 mg once daily for up to 12 weeks.

The double-blind placebo-controlled treatment period the study has three arms:

  • NBI-98854 50 mg once daily for 6 weeks
  • NBI-98854 100 mg once daily for 2 weeks followed by 50 mg once daily for the remaining 4 weeks
  • placebo

At the end of the 6-week placebo-controlled double-blind treatment period, subjects will continue in the study for an additional 6-week open-label period where all subjects who have completed the double-blind treatment period will receive NBI-98854 50 mg once daily. Two and four weeks after the last dose of study drug, follow-up assessments will be performed.

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

    25 mg capsule

  • NBI-98854Drug

    50 mg capsule

  • PlaceboDrug

Study groups in NCT01688037
Study groupRoleWhat they receive
NBI-98854 50 mgExperimentalNBI-98854 50 mg administered as two (2) 25 mg capsules by mouth, taken every morning between 7:00am - 10:00am for 6 weeks.
Receives: Drug: NBI-98854
NBI-98854 100 mg and 50 mgExperimentalNBI-98854 100 mg administered as two (2) 50 mg capsules taken every morning between 7:00am - 10:00am for 2 weeks. After 2 weeks, NBI-98854 50 mg administered by two (2) 25 mg capsules by mouth, taken every morning between 7:00am - 10:00am for remaining 4 weeks.
Receives: Drug: NBI-98854
PlaceboPlacebo comparatorCapsule containing no active substance, manufactured to mimic NBI-98854 25 mg and 50 mg capsules.
Receives: 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

    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. The primary efficacy endpoint was the change from baseline in the AIMS dyskinesia total score at Week 6 between the pooled NBI-98854 50+100 mg group and placebo group analyzed using the ANCOVA model (LOCF, ITT analysis set).

    Measured: Baseline and Week 6

Secondary outcomes (2)

  1. Clinical Global Impression - Global Improvement of TD (CGI-TD)

    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). The ANOVA analysis of CGI-TD was conducted for the pooled NBI-98854 50+100 mg group and placebo group.

    Measured: Week 6

  2. Clinical Global Impression - Global Improvement of TD (CGI-TD) at Week 2

    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 2

Timeline

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

  1. First posted19 Sep 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionSep 2013
  4. Study completionOct 2013

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
109 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01688037
Sponsor's protocol ID
NBI-98854-1201
Status last verified
Oct 2017
First submitted
11 Sep 2012
Last updated
8 Nov 2017
Data monitoring committee
No

Publications

  • 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 2 study testing NBI-98854 in people with Tardive Dyskinesia, run by Neurocrine Biosciences at 51 sites in 2 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 8 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States, 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 8 Nov 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 NCT01688037, which also lists 1 linked publication.

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 8 Nov 2017.

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