NCT02405091

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
167

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2015

Geographic Reach
3 countries

48 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

November 30, 2018

Completed
Last Updated

November 30, 2018

Status Verified

November 1, 2018

Enrollment Period

2 years

First QC Date

March 27, 2015

Results QC Date

September 11, 2018

Last Update Submit

November 29, 2018

Conditions

Tardive Dyskinesia

Outcome Measures

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.

    52 weeks

Secondary Outcomes (4)

  • 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

    Baseline and Week 48

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

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

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

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

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

    Week 48

Study Arms (2)

Dose Group 1

EXPERIMENTAL

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

Drug: NBI-98854

Dose Group 2

EXPERIMENTAL

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

Drug: NBI-98854

Interventions

NBI-98854DRUG
Dose Group 1Dose Group 2

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (48)

Unknown Facility

Anaheim, California, United States

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Glendale, California, United States

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Irvine, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Oakland, California, United States

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San Bernardino, California, United States

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San Diego, California, United States

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Torrance, California, United States

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Hockessin, Delaware, United States

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Bradenton, Florida, United States

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Hialeah, Florida, United States

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Kissimmee, Florida, United States

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Miami, Florida, United States

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North Miami, Florida, United States

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Orlando, Florida, United States

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Honolulu, Hawaii, United States

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Chicago, Illinois, United States

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Shreveport, Louisiana, United States

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Natick, Massachusetts, United States

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Worcester, Massachusetts, United States

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Ann Arbor, Michigan, United States

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St Louis, Missouri, United States

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Lincoln, Nebraska, United States

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Omaha, Nebraska, United States

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Nashua, New Hampshire, United States

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Buffalo, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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High Point, North Carolina, United States

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Dayton, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Conshohocken, Pennsylvania, United States

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Norristown, Pennsylvania, United States

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Phoenixville, Pennsylvania, United States

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Scranton, Pennsylvania, United States

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DeSoto, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Irving, Texas, United States

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Petersburg, Virginia, United States

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Seattle, Washington, United States

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Spokane, Washington, United States

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Vancouver, British Columbia, Canada

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London, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Unknown Facility

San Juan, Puerto Rico

Location

Related Publications (1)

  • 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.

    PMID: 31617235DERIVED

MeSH Terms

Conditions

Tardive Dyskinesia

Interventions

valbenazine

Condition Hierarchy (Ancestors)

Dyskinesia, Drug-InducedDyskinesiasMovement DisordersCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Neurocrine Medical Information
Organization
Neurocrine Biosciences, Inc.
medinfo@neurocrine.com
877-641-3461

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2015

First Posted

April 1, 2015

Study Start

March 1, 2015

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

November 30, 2018

Results First Posted

November 30, 2018

Record last verified: 2018-11

Locations

PR(1)CA(4)US(43)