Open-Label Safety and Tolerability Study of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome
1 other identifier
interventional
85
2 countries
37
Brief Summary
This is a Phase 2b, multicenter, open-label study to evaluate the safety and tolerability of optimized doses of NBI-98854 administered once daily for 24 weeks in pediatric subjects with Tourette Syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2018
Shorter than P25 for phase_2
37 active sites
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
February 8, 2018
CompletedFirst Submitted
Initial submission to the registry
February 19, 2018
CompletedFirst Posted
Study publicly available on registry
February 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 12, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 12, 2019
CompletedResults Posted
Study results publicly available
February 23, 2022
CompletedFebruary 23, 2022
January 1, 2022
1.4 years
February 19, 2018
January 29, 2022
January 29, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
A TEAE is an adverse event not present prior to the initiation of study drug dosing, or is an already present event that worsens either in intensity or frequency following the initiation of study drug dosing. All qualifying TEAE are reported regardless of threshold.
Baseline through Week 24
Study Arms (1)
Valbenazine
EXPERIMENTALValbenazine administered once daily for up to 24 weeks
Interventions
vesicular monoamine transporter 2 (VMAT2) inhibitor
Eligibility Criteria
You may qualify if:
- Have participated in and completed Study NBI-98854-TS2003
- Have a clinical diagnosis of Tourette Syndrome (TS)
- If using maintenance medication(s) for TS or TS spectrum diagnoses (e.g. obsessive-compulsive disorder \[OCD\], Attention-Deficit Hyperactivity Disorder \[ADHD\]), be on stable doses
- Be in good general health
- Adolescent subjects (12 to 18 years of age) must have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids and a negative alcohol screen
- Subjects of childbearing potential who do not practice total abstinence 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
You may not qualify if:
- Have an active, clinically significant unstable medical condition within 1 month prior to screening
- Have a known history of long QT syndrome or cardiac arrhythmia
- Have a known history of neuroleptic malignant syndrome
- Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed)
- Have an allergy, hypersensitivity, or intolerance to vesicular monoamine transporter 2 (VMAT2) inhibitors
- Have a blood loss ≥250 mL or donated blood within 56 days prior to baseline
- Have a known history of substance (drug) dependence, or substance or alcohol abuse
- Have a significant risk of suicidal or violent behavior
- Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Neurocrine Clinical Site
Sun City, Arizona, 85351, United States
Neurocrine Clinical Site
Anaheim, California, 92805, United States
Neurocrine Clinical Site
San Diego, California, 92108, United States
Neurocrine Clinical Site
Santa Ana, California, 92705, United States
Neurocrine Clinical Site
Santa Clarita, California, 91321, United States
Neurocrine Clinical Site
New Haven, Connecticut, 06510, United States
Neurocrine Clinical Site
Boca Raton, Florida, 33431, United States
Neurocrine Clinical Site
Gulf Breeze, Florida, 32561, United States
Neurocrine Clinical Site
Hialeah, Florida, 33013, United States
Neurocrine Clinical Site
Orlando, Florida, 32801, United States
Neurocrine Clinical Site
Orlando, Florida, 32803, United States
Neurocrine Clinical Site
St. Petersburg, Florida, 33701, United States
Neurocrine Clinical Site
Tampa, Florida, 33614, United States
Neurocrine Clinical Site
Chicago, Illinois, 60634, United States
Neurocrine Clinical Site
Naperville, Illinois, 60563, United States
Neurocrine Clinical Site
Iowa City, Iowa, 52242, United States
Neurocrine Clinical Site
Leawood, Kansas, 66206, United States
Neurocrine Clinical Site
Ann Arbor, Michigan, 48105, United States
Neurocrine Clinical Site
Bloomfield Hills, Michigan, 48371, United States
Neurocrine Clinical Site
St Louis, Missouri, 63110, United States
Neurocrine Clinical Site
Lincoln, Nebraska, 68526, United States
Neurocrine Clinical Site
Nashua, New Hampshire, 03060, United States
Neurocrine Clinical Site
Mount Arlington, New Jersey, 07856, United States
Neurocrine Clinical Site
Voorhees Township, New Jersey, 08043, United States
Neurocrine Clinical Site
New York, New York, 10036, United States
Neurocrine Clinical Site
The Bronx, New York, 10467, United States
Neurocrine Clinical Site
Durham, North Carolina, 27705, United States
Neurocrine Clinical Site
Mason, Ohio, 45040, United States
Neurocrine Clinical Site
Oklahoma City, Oklahoma, 73112, United States
Neurocrine Clinical Site
Charleston, South Carolina, 29414, United States
Neurocrine Clinical Site
Dallas, Texas, 75243, United States
Neurocrine Clinical Site
Houston, Texas, 77030, United States
Neurocrine Clinical Site
Houston, Texas, 77058, United States
Neurocrine Clinical Site
San Antonio, Texas, 78249, United States
Neurocrine Clinical Site
Everett, Washington, 98201, United States
Neurocrine Clinical Site
Tacoma, Washington, 98405, United States
Neurocrine Clinical Site
San Juan, PR, 00926, Puerto Rico
Related Publications (1)
Farber RH, Angelov A, Kim K, Carmack T, Thai-Cuarto D, Roberts E. Clinical development of valbenazine for tics associated with Tourette syndrome. Expert Rev Neurother. 2021 Apr;21(4):393-404. doi: 10.1080/14737175.2021.1898948. Epub 2021 Apr 1.
PMID: 33682568BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Neurocrine Medical Information
- Organization
- Neurocrine Biosciences
Study Officials
- STUDY DIRECTOR
Clinical Development Lead
Neurocrine Biosciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2018
First Posted
February 23, 2018
Study Start
February 8, 2018
Primary Completion
July 12, 2019
Study Completion
July 12, 2019
Last Updated
February 23, 2022
Results First Posted
February 23, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share