Study Stopped
Study stopped early due to investigational drug not meeting primary endpoint in the main study T-Force GOLD (NBI-98854-TS2003); no safety concerns identified.
Rollover Study for Continuing NBI-98854 Administration in Pediatric Subjects With Tourette Syndrome
Open-Label Rollover Study for Continuing NBI-98854 Administration for the Treatment of Pediatric Subjects With Tourette Syndrome
1 other identifier
interventional
6
2 countries
10
Brief Summary
This is an open-label, rollover study to collect long-term safety, tolerability, and investigator- and participant-reported pharmacodynamic (PD) data after chronic administration of NBI-98854 in pediatric participants with Tourette Syndrome (TS), as well as to provide open-label access to NBI-98854 for the treatment of TS for pediatric participants who have taken part in a Phase 2 NBI-98854 study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2018
Shorter than P25 for phase_2
10 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
October 17, 2018
CompletedFirst Submitted
Initial submission to the registry
November 5, 2018
CompletedFirst Posted
Study publicly available on registry
November 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 18, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 18, 2019
CompletedResults Posted
Study results publicly available
April 19, 2022
CompletedApril 19, 2022
March 1, 2022
4 months
November 5, 2018
January 29, 2022
March 25, 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.
Up to 16 Weeks
Study Arms (1)
NBI-98854
EXPERIMENTALNBI-98854 administered once daily for up to 96 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Have a clinical diagnosis of Tourette Syndrome (TS)
- Have participated in the NBI-98854-TS2004 or NBI 98854-TS2005 Phase 2 studies
- If using maintenance medication(s) for TS and/or TS spectrum diagnoses (e.g. obsessive-compulsive disorder \[OCD\], Attention-Deficit Hyperactivity Disorder \[ADHD\]), be on stable doses
- Be in good general health
- 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 before 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 VMAT2 inhibitors
- Have a blood loss ≥250 mL or donated blood within 56 days, or donated plasma within 7 days, before the start of the study
- Have a known history of substance dependence, substance (drug) or alcohol abuse within 3 months before the start of the study
- Have a significant risk of suicidal or violent behavior
- Have received an investigational drug within 30 days before the start of the study or plan to use an investigational drug (other than NBI-98854) during the study
- Are currently participating in another NBI-98854 clinical study
- Are pregnant (for females)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Neurocrine Clinical Site
Anaheim, California, 92805, United States
Neurocrine Clinical Site
San Diego, California, 92108, United States
Neurocrine Clinical Site
Gulf Breeze, Florida, 32561, United States
Neurocrine Clinical Site
Hialeah, Florida, 33013, United States
Neurocrine Clinical Site
Chicago, Illinois, 60634, United States
Neurocrine Clinical Site
Naperville, Illinois, 60563, United States
Neurocrine Clinical Site
Lincoln, Nebraska, 68526, United States
Neurocrine Clinical Site
Dallas, Texas, 75243, United States
Neurocrine Clinical Site
Houston, Texas, 77058, United States
Neurocrine Clinical Site
San Juan, PR, 00926, Puerto Rico
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
November 5, 2018
First Posted
November 6, 2018
Study Start
October 17, 2018
Primary Completion
February 18, 2019
Study Completion
February 18, 2019
Last Updated
April 19, 2022
Results First Posted
April 19, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share