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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03325010
Other study ID # NBI-98854-TS2003
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 5, 2017
Est. completion date November 16, 2018

Study information

Verified date June 2021
Source Neurocrine Biosciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a Phase 2b, randomized, double-blind, placebo-controlled, dose-optimization study to evaluate the efficacy, safety, and tolerability of NBI-98854 titrated to the subject's optimal dose administered once daily (qd) for a total of 12 weeks of treatment in pediatric subjects with TS.


Recruitment information / eligibility

Status Completed
Enrollment 127
Est. completion date November 16, 2018
Est. primary completion date November 1, 2018
Accepts healthy volunteers No
Gender All
Age group 6 Years to 17 Years
Eligibility Inclusion Criteria: 1. Have a clinical diagnosis of Tourette Syndrome (TS) 2. Have at least moderate tic severity 3. Have TS symptoms that impair school, occupational, and/or social function 4. 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 5. Be in good general health 6. Adolescent subjects (12 to 17 years of age) must have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids and a negative alcohol screen 7. 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 Exclusion Criteria: 1. Have an active, clinically significant unstable medical condition within 1 month prior to screening 2. Have a known history of long QT syndrome or cardiac arrhythmia 3. Have a known history of neuroleptic malignant syndrome 4. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed) 5. Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors 6. Have a blood loss =250 mL or donated blood within 30 days prior to screening 7. Have a known history of substance dependence, substance (drug) or alcohol abuse 8. Have a significant risk of suicidal or violent behavior 9. Have initiated Comprehensive Behavioral Intervention for Tics (CBIT) during the screening period or at baseline or plan to initiate CBIT during the study 10. Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Valbenazine
vesicular monoamine transporter 2 (VMAT2) inhibitor
Placebo oral capsule
non-active dosage form

Locations

Country Name City State
Puerto Rico Neurocrine Clinical Site San Juan
United States Neurocrine Clinical Site Anaheim California
United States Neurocrine Clinical Site Boston Massachusetts
United States Neurocrine Clinical Site Bronx New York
United States Neurocrine Clinical Site Chicago Illinois
United States Neurocrine Clinical Site Chicago Illinois
United States Neurocrine Clinical Site Dallas Texas
United States Neurocrine Clinical Site Durham North Carolina
United States Neurocrine Clinical Site Everett Washington
United States Neurocrine Clinical Site Hialeah Florida
United States Neurocrine Clinical Site Hialeah Florida
United States Neurocrine Clinical Site Hialeah Florida
United States Neurocrine Clinical Site Houston Texas
United States Neurocrine Clinical Site Iowa City Iowa
United States Neurocrine Clinical Site Irving Texas
United States Neurocrine Clinical Site Leawood Kansas
United States Neurocrine Clinical Site Lincoln Nebraska
United States Neurocrine Clinical Site Loxahatchee Groves Florida
United States Neurocrine Clinical Site Memphis Tennessee
United States Neurocrine Clinical Site Mount Arlington New Jersey
United States Neurocrine Clinical Site Naperville Illinois
United States Neurocrine Clinical Site Nashua New Hampshire
United States Neurocrine Clinical Site New Haven Connecticut
United States Neurocrine Clinical Site New York New York
United States Neurocrine Clinical Site Orange City Florida
United States Neurocrine Clinical Site Orlando Florida
United States Neurocrine Clinical Site Orlando Florida
United States Neurocrine Clinical Site Rogers Arkansas
United States Neurocrine Clinical Site San Diego California
United States Neurocrine Clinical Site Santa Clarita California
United States Neurocrine Clinical Site Seattle Washington
United States Neurocrine Clinical Site Spokane Washington
United States Neurocrine Clinical Site Sun City Arizona
United States Neurocrine Clinical Site Tampa Florida
United States Neurocrine Clinical Site Voorhees New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Neurocrine Biosciences

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline to Week 12 in the Yale Global Tic Severity Scale (YGTSS) Total Tic Score (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 12
Secondary Change From Baseline to Week 12 in the Clinical Global Impression of Tics Severity (CGI-Tics-Severity) Score The CGI-Tics-Severity scale is used to assess overall severity on a 7-point scale. Each of the CGI-Tics-Severity response categories was assigned a numerical score as follows: 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patient. Baseline, Week 12
Secondary Participants Who Are a Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS) Responder at Week 12 A TTS responder is defined, on a per-visit basis, as a participant whose TTS value is reduced by at least 30% from baseline at the specified postbaseline visit. Baseline, Week 12
Secondary Participants Who Are a Clinical Global Impression of Tourette Syndrome Improvement (CGI-TS-Improvement) Responder at Week 12 The CGI-TS-Improvement scale is used to assess overall improvement since the initiation of study drug dosing on a 7-point scale. A CGI-TS-Improvement responder is defined, on a per-visit basis, as a participant whose CGI-TS-Improvement score is 1 ("Very much improved") or 2 ("Much improved") at the specified postbaseline visit. Week 12
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