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CompletedNCT02405091Kinect 4Updated Nov 30, 2018Results posted

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

A Phase 3 interventional study of NBI-98854 in Tardive Dyskinesia, sponsored by Neurocrine Biosciences. Completed at 48 sites in 3 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-11-30.

Sponsored by Neurocrine Biosciences · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
167
Allocation
Non-randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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 neuroleptic-induced TD or mood disorder with neuroleptic-induced TD.

02

Conditions studied

  • Tardive Dyskinesia
03

In context

Dyskinesias

270 studies on the registry are indexed under Dyskinesias; 41 are open to participants now.

This study's enrollment of 167 is above the median of 44 across 192 interventional studies indexed under Dyskinesias.

Browse Dyskinesias studies →

Lead sponsor

Neurocrine Biosciences is the lead sponsor of 85 studies on the registry; 16 are open to participants now.

Of its 35 completed or terminated interventional studies of FDA-regulated products, 23 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 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.
  2. Female subjects must not be pregnant.
  3. Have one of the following clinical diagnoses for at least 3 months prior to screening: Schizophrenia or Schizoaffective Disorder, or Mood Disorder
  4. Have a clinical diagnosis of neuroleptic-induced TD for at least 3 months prior to screening.
  5. Have moderate or severe TD
  6. If using maintenance medication(s) for schizophrenia or schizoaffective disorder, or mood disorder, be on stable doses.
  7. Be in general good health.
  8. Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.
  9. Have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids.

Exclusion criteria

Exclusion Criteria

  1. Have an active, clinically significant unstable medical condition within 1 month prior to screening.
  2. Have a known history of substance dependence, substance (drug) or alcohol abuse.
  3. Have a significant risk of suicidal or violent behavior.
  4. Have a known history of neuroleptic malignant syndrome.
  5. Have a known history of long QT syndrome or cardiac tachy-arrhythmia.
  6. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed).
  7. Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study.
  8. Have a blood loss ≥550 mL or donated blood within 30 days prior to Baseline.
  9. Have an allergy, hypersensitivity, or intolerance to tetrabenazine.
  10. Are currently pregnant or breastfeeding.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
167 participants (actual)

Study arms

  • Experimental
    Dose Group 1

    Fixed dose of NBI-98854 administered once daily for 48 weeks

    Drug: NBI-98854

  • Experimental
    Dose Group 2

    Fixed dose of NBI-98854 administered once daily up to 48 weeks

    Drug: NBI-98854

Interventions

  • DrugNBI-98854
06

What researchers measure

Primary outcomes

  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.

    Time frame: 52 weeks

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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).

    Time frame: Week 48

07

Results

Posted Nov 30, 2018

Participant flow

This study enrolled participants with clinical diagnoses of schizophrenia or schizoaffective disorder or mood disorder with neuroleptic-induced tardive dyskinesia (TD) from 45 centers in North America and Puerto Rico.

Participant flow — Overall Study
MilestoneValbenazine 40mgValbenazine 80mgValbenazine 80/40mg
Started4910711
Completed20749
Not completed29332
Withdrew: Adverse event16100
Withdrew: Protocol violation100
Withdrew: Noncompliance162
Withdrew: Withdrawal by subject480
Withdrew: Death010
Withdrew: Lost to follow-up560
Withdrew: Physician decision220

Outcome measures

PrimaryNumber 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.

Time frame:
52 weeks
Reported as:
Count of participants · Participants
Number of Participants Monitored for Long-Term Safety of Valbenazine
ParticipantsValbenazine 40mgValbenazine 80mgValbenazine 80/40mg
Number of Participants Monitored for Long-Term Safety of Valbenazine4510711
SecondarySeverity 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.

Time frame:
Baseline and Week 48
Reported as:
Mean · score on a scale
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
score on a scaleValbenazine 40mgValbenazine 80mgValbenazine 80/40mg
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-10.2 ± 1.2-11.0 ± 0.5-7.2 ± 2.2
SecondarySeverity 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.

Time frame:
Baseline, Change from Baseline at Week 8, and Change from Baseline at Week 52
Reported as:
Mean · score on a scale
Severity of Tardive Dyskinesia (TD) Symptoms Assessed by Abnormal Involuntary Movements Scale (AIMS) Dyskinesia Total Score Change From Baseline; Central AIMS Video Raters
score on a scaleValbenazine 40mgValbenazine 80mgValbenazine 80/40mg
At Baseline10.2 ± 0.610.0 ± 0.49.3 ± 0.8
Change from Baseline at Week 8-4.5 ± 0.7-3.5 ± 0.4-4.9 ± 1.2
Change from Baseline at Week 52-1.8 ± 1.0-3.3 ± 0.50.2 ± 1.3
SecondarySeverity 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.

Time frame:
Baseline, Change from Baseline at Week 8, and Change from Baseline at Week 52
Reported as:
Mean · score on a scale
Severity of Tardive Dyskinesia (TD) Symptoms Assessed by Abnormal Involuntary Movements Scale (AIMS) Dyskinesia Total Score Change From Baseline; On-Site AIMS Raters
score on a scaleValbenazine 40mgValbenazine 80mgValbenazine 80/40mg
At Baseline14.2 ± 0.815.0 ± 0.412.8 ± 1.4
Change from Baseline at Week 8-7.1 ± 1.0-5.4 ± 0.5-7.4 ± 1.6
Change from Baseline at Week 52-3.8 ± 1.2-4.6 ± 0.7-3.3 ± 1.8
SecondaryClinical 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).

Time frame:
Week 48
Reported as:
Mean · score on a scale
Clinical Global Impression - Global Improvement of Tardive Dyskinesia (CGI-TD) at Week 48
score on a scaleValbenazine 40mgValbenazine 80mgValbenazine 80/40mg
Clinical Global Impression - Global Improvement of Tardive Dyskinesia (CGI-TD) at Week 481.7 ± 0.21.6 ± 0.12.3 ± 0.4

Adverse events

Collected over Up to 52 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Valbenazine 40 mg Through Week 40/163 (0%)0/163 (0%)0/163 (0%)
Valbenazine 40mg Week 4 Through Week 520/35 (0%)3/35 (8.6%)5/35 (14.3%)
Valbenazine 80mg Week 4 Through Week 521/107 (0.9%)17/107 (15.9%)15/107 (14%)
Valbenazine 80/40mg Week 4 Through Week 520/11 (0%)1/11 (9.1%)1/11 (9.1%)
Most frequent serious events
Showing 10 of 22
Most frequent serious events
EventValbenazine 40 mg Through Week 4Valbenazine 40mg Week 4 Through Week 52Valbenazine 80mg Week 4 Through Week 52Valbenazine 80/40mg Week 4 Through Week 52
Joint dislocationInjury, poisoning and procedural complications0/1630/350/1071/11
Lung cancer metastaticNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/1631/350/1070/11
Confusional statePsychiatric disorders0/1631/350/1070/11
SchizophreniaPsychiatric disorders0/1631/351/1070/11
Suicidal ideationPsychiatric disorders0/1631/351/1070/11
DiverticulitisInfections and infestations0/1630/352/1070/11
Abdominal painGastrointestinal disorders0/1630/351/1070/11
Non-cardiac chest painGeneral disorders0/1630/351/1070/11
CholelithiasisHepatobiliary disorders0/1630/351/1070/11
OsteomyelitisInfections and infestations0/1630/351/1070/11
Most frequent other events
Most frequent other events
EventValbenazine 40 mg Through Week 4Valbenazine 40mg Week 4 Through Week 52Valbenazine 80mg Week 4 Through Week 52Valbenazine 80/40mg Week 4 Through Week 52
Urinary tract infectionInfections and infestations0/1633/359/1071/11
HeadacheNervous system disorders0/1632/356/1070/11

Baseline characteristics

Safety analysis set: included all participants who are enrolled into the study and received study drug, with the following two exclusions: (a) participants who withdrew from the study and returned all previously dispensed study drug with all doses present, and (b) participants who had no post-baseline data collected

Age, Continuous
Age, Continuous(years)Valbenazine 40mgValbenazine 80mgValbenazine 80/40mgTotal
Mean56.8 (30 to 80)57.8 (32 to 82)56.3 (42 to 69)57.4 (30 to 82)
Sex: Female, Male
Sex: Female, Male(Participants)Valbenazine 40mgValbenazine 80mgValbenazine 80/40mgTotal
Female2448577
Male2159686
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Valbenazine 40mgValbenazine 80mgValbenazine 80/40mgTotal
Hispanic or Latino748156
Not Hispanic or Latino385910107
Unknown or Not Reported0000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Valbenazine 40mgValbenazine 80mgValbenazine 80/40mgTotal
Asian1001
Black or African American1631148
Caucasian267410110
Native Hawaiian or Other Pacific Islander1102
Other: Latina1001
Other: Mulatto0101
BMI at Screening
BMI at Screening(kg/m^2)Valbenazine 40mgValbenazine 80mgValbenazine 80/40mgTotal
Mean27.80 (18.0 to 40.8)28.95 (18.6 to 41.7)27.45 (22.2 to 33.3)28.53 (18.0 to 41.7)
Primary Psychiatric Diagnosis
Primary Psychiatric Diagnosis(Participants)Valbenazine 40mgValbenazine 80mgValbenazine 80/40mgTotal
Schizophrenia/schizoaffective37766119
Mood disorder831544
Age at Diagnosis
Age at Diagnosis(years)Valbenazine 40mgValbenazine 80mgValbenazine 80/40mgTotal
Age at Schizophrenia/Schizoaffective Diagnosis30.9 (14 to 59)28.0 (9 to 63)26.2 (17 to 45)28.8 (9 to 63)
Age at Mood Disorder Diagnosis40.6 (32 to 50)36.9 (14 to 55)28.3 (11 to 62)36.8 (11 to 62)
Age at Tardive Dyskinesia Diagnosis
Age at Tardive Dyskinesia Diagnosis(years)Valbenazine 40mgValbenazine 80mgValbenazine 80/40mgTotal
Mean47.8 (24 to 73)49.2 (16 to 69)44.3 (20 to 66)48.4 (16 to 73)

2 further baseline measures are reported on the registry.

08

Study locations

48 sites
  • Anaheim, California, United States
  • Glendale, California, United States
  • Irvine, California, United States
  • Long Beach, California, United States
  • Los Angeles, California, United States
  • Oakland, California, United States
  • San Bernardino, California, United States
  • San Diego, California, United States
  • Torrance, California, United States
  • Hockessin, Delaware, United States
  • Bradenton, Florida, United States
  • Hialeah, Florida, United States
  • Kissimmee, Florida, United States
  • Miami, Florida, United States
  • North Miami, Florida, United States
  • Orlando, Florida, United States
  • Honolulu, Hawaii, United States
  • Chicago, Illinois, United States
  • Shreveport, Louisiana, United States
  • Natick, Massachusetts, United States
  • Worcester, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • Saint Louis, Missouri, United States
  • Lincoln, Nebraska, United States
  • Omaha, Nebraska, United States
  • Nashua, New Hampshire, United States
  • Buffalo, New York, United States
  • New York, New York, United States
  • Rochester, New York, United States
  • High Point, North Carolina, United States
  • Dayton, Ohio, United States
  • Oklahoma City, Oklahoma, United States
  • Conshohocken, Pennsylvania, United States
  • Norristown, Pennsylvania, United States
  • Phoenixville, Pennsylvania, United States
  • Scranton, Pennsylvania, United States
  • DeSoto, Texas, United States
  • Fort Worth, Texas, United States
  • Houston, Texas, United States
  • Irving, Texas, United States
  • Petersburg, Virginia, United States
  • Seattle, Washington, United States
  • Spokane, Washington, United States
  • Vancouver, British Columbia, Canada
  • London, Ontario, Canada
  • Toronto, Ontario, Canada
  • Montreal, Quebec, Canada
  • San Juan, Puerto Rico
09

References and documents

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 ↗
  • Josiassen RC, Kane JM, Liang GS, Burke J, O'Brien CF. Long-Term Safety and Tolerability of Valbenazine (NBI-98854) in Subjects with Tardive Dyskinesia and a Diagnosis of Schizophrenia or Mood Disorder. Psychopharmacol Bull. 2017 Aug 1;47(3):61-68. PubMed 28839341 ↗

Study documents

  • Study protocol · Dec 3, 2015
  • Statistical analysis plan · Apr 5, 2016

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02405091
Lead sponsor
Neurocrine Biosciences
Responsible party
Sponsor
First posted
Apr 1, 2015
Start date
Mar 2015
Primary completion
Mar 2017
Completion
Mar 2017
Results posted
Nov 30, 2018
Last update
Nov 30, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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