NCT02736955

Brief Summary

This Phase 3b, rollover study will provide participants who completed a Phase 3 valbenazine (NBI-98854) study open-label access to valbenazine (fixed doses administered once daily) for the treatment of adults with TD until valbenazine is anticipated to be available commercially or they complete 72 weeks of treatment. This study will allow enrollment of up to 150 medically stable male and female participants with TD who previously participated in and completed the NBI-98854-1304 (Kinect 3) or NBI-98854-1402 (Kinect 4) Phase 3 study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
161

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

27 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

First Submitted

Initial submission to the registry

April 8, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 13, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

June 13, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

December 19, 2018

Completed
Last Updated

December 19, 2018

Status Verified

November 1, 2018

Enrollment Period

1 year

First QC Date

April 8, 2016

Results QC Date

October 10, 2018

Last Update Submit

November 28, 2018

Conditions

Tardive Dyskinesia

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Monitored for Long-term Safety of Valbenazine

    Incidence of adverse events and monitoring of vital signs, clinical laboratory values, and electrocardiograms. All AEs were coded into preferred terms according to MedDRA (Medical Dictionary for Regulatory Activities) and classified by system organ class (SOC). Summaries of the incidence of all treatment-emergent AEs, treatment-related AEs, SAEs, and AEs leading to study drug discontinuation were prepared.

    60 weeks

Secondary Outcomes (2)

  • Number of Participants With Clinical Response as Assessed by the Clinical Global Impression of Tardive Dyskinesia - Severity (CGI-TD-Severity) Scale

    Baseline and Weeks 12, 24, 36, 48, and 60

  • Number of Participants With Clinical Response as Assessed by the Patient Satisfaction Questionnaire (PSQ)

    Baseline and Weeks 12, 24, 36, 48, and 60

Study Arms (1)

Valbenazine

EXPERIMENTAL

Fixed dose of valbenazine administered once daily for up to 72 weeks

Drug: Valbenazine

Interventions

ValbenazineDRUG
Also known as: NBI-98854
Valbenazine

Eligibility Criteria

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

You may qualify if:

  • Have participated in and completed the NBI-98854-1304 (Kinect 3) or NBI-98854-1402 (Kinect 4) Phase 3 study.
  • Participants of childbearing potential must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently throughout the study and until 30 days after the last dose of valbenazine.
  • If using maintenance medication(s) for schizophrenia or schizoaffective disorder, mood disorder, or other conditions, be on stable doses.
  • Be in general good health.
  • Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.

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 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 valbenazine) 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 (27)

Unknown Facility

Anaheim, California, United States

Location

Unknown Facility

National City, California, United States

Location

Unknown Facility

Norwalk, California, United States

Location

Unknown Facility

Oakland, California, United States

Location

Unknown Facility

San Bernardino, California, United States

Location

Unknown Facility

San Diego, California, United States

Location

Unknown Facility

Torrance, California, United States

Location

Unknown Facility

Hialeah, Florida, United States

Location

Unknown Facility

North Miami, Florida, United States

Location

Unknown Facility

Orlando, Florida, United States

Location

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Shreveport, Louisiana, United States

Location

Unknown Facility

Worcester, Massachusetts, United States

Location

Unknown Facility

Cedarhurst, New York, United States

Location

Unknown Facility

Dayton, Ohio, United States

Location

Unknown Facility

Shaker Heights, Ohio, United States

Location

Unknown Facility

Oklahoma City, Oklahoma, United States

Location

Unknown Facility

Norristown, Pennsylvania, United States

Location

Unknown Facility

Charleston, South Carolina, United States

Location

Unknown Facility

Franklin, Tennessee, United States

Location

Unknown Facility

Memphis, Tennessee, United States

Location

Unknown Facility

DeSoto, Texas, United States

Location

Unknown Facility

Fort Worth, Texas, United States

Location

Unknown Facility

Irving, Texas, United States

Location

Unknown Facility

Salt Lake City, Utah, United States

Location

Unknown Facility

Petersburg, Virginia, United States

Location

Unknown Facility

Spokane, Washington, United States

Location

Related Publications (1)

  • Lindenmayer JP, Verghese C, Marder SR, Burke J, Jimenez R, Siegert S, Liang GS, O'Brien CF. A long-term, open-label study of valbenazine for tardive dyskinesia. CNS Spectr. 2021 Aug;26(4):345-353. doi: 10.1017/S109285292000108X. Epub 2020 May 18.

    PMID: 32419679DERIVED

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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2016

First Posted

April 13, 2016

Study Start

June 13, 2016

Primary Completion

June 30, 2017

Study Completion

June 30, 2017

Last Updated

December 19, 2018

Results First Posted

December 19, 2018

Record last verified: 2018-11

Locations

US(27)