Safety and Efficacy Study of NBI-98854 in Adults With Tourette Syndrome
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of NBI-98854 in Adult Subjects With Tourette Syndrome
1 other identifier
interventional
124
1 country
30
Brief Summary
Phase 2, double-blind, placebo-controlled study to assess the safety and efficacy of NBI-98854 administered once daily (qd) for a total of 8 weeks of treatment. This study will enroll approximately 90 male and female subjects clinically diagnosed with Tourette Syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2015
Shorter than P25 for phase_2
30 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
First Submitted
Initial submission to the registry
October 19, 2015
CompletedFirst Posted
Study publicly available on registry
October 21, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedResults Posted
Study results publicly available
May 7, 2020
CompletedMay 7, 2020
April 1, 2020
1.1 years
October 19, 2015
April 7, 2020
April 27, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline to Week 8 in the YGTSS TTS
The YGTSS is designed to rate the overall severity of motor and phonic tic symptoms across a range of dimensions: number, frequency, intensity, complexity, and interference. The YGTSS was administered by the investigator (or qualified designee) using a computer-based structured clinical interview. The TTS is the sum of the 5 motor tic items and the 5 phonic (vocal) tic items and ranges from 0 to 50, with higher scores representing greater severity
Baseline, Week 8
Secondary Outcomes (5)
Clinical Global Impression of Change Tourette Syndrome (CGI-TS)-Improvement Score at Week 8
Week 8
Change From Baseline to Week 8 in the Clinical Global Impression of Tics (CGI-Tics)-Severity Score
Baseline, Week 8
Change From Baseline to Last Visit in the Rush Video-based Tic Rating Scale (RTRS) Total Score
Baseline, Week 8
Change From Baseline to Week 8 in the YGTSS Global Tic Severity Score
Baseline, Week 8
Change From Baseline to Week 8 in the Premonitory Urge for Tics Scale (PUTS) Total Score
Baseline, Week 8
Study Arms (3)
Placebo
PLACEBO COMPARATORPlacebo administered once daily for 8 weeks
Dose Group 1
EXPERIMENTALFixed dose administered once daily for 8 weeks
Dose Group 2
EXPERIMENTALFixed dose administered once daily for 8 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Have a clinical diagnosis of Tourette Syndrome (TS)
- Have at least moderate tic severity
- Have TS symptoms that impair school, occupational, and/or social function
- 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
- Have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, or opiates, 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 tachy-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 known history of substance dependence, substance (drug) or alcohol abuse
- Have a significant risk of suicidal or violent behavior
- Are currently pregnant or breastfeeding
- Have initiated Comprehensive Behavioral Intervention for Tics (CBIT) during the screening period or at baseline or plan to initiate CBIT during the study
- 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 screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Unknown Facility
Long Beach, California, United States
Unknown Facility
National City, California, United States
Unknown Facility
San Bernardino, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Upland, California, United States
Unknown Facility
Gainesville, Florida, United States
Unknown Facility
Hialeah, Florida, United States
Unknown Facility
St. Petersburg, Florida, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Natick, Massachusetts, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Nashua, New Hampshire, United States
Unknown Facility
Summit, New Jersey, United States
Unknown Facility
Albany, New York, United States
Unknown Facility
Manhasset, New York, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Staten Island, New York, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Norristown, Pennsylvania, United States
Unknown Facility
Nashville, Tennessee, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Irving, Texas, United States
Unknown Facility
Orem, Utah, United States
Unknown Facility
Salt Lake City, Utah, United States
Unknown Facility
Kirkland, Washington, United States
Unknown Facility
Spokane, Washington, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Neurocrine Medical Information
- Organization
- Neurocrine Biosciences, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2015
First Posted
October 21, 2015
Study Start
November 1, 2015
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
May 7, 2020
Results First Posted
May 7, 2020
Record last verified: 2020-04