Brief Title
Safety and Efficacy Study of NBI-98854 in Children and Adolescents With Tourette Syndrome
Official Title
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of NBI-98854 in Pediatric Subjects With Tourette Syndrome
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 6 weeks of treatment. This study will enroll approximately 90 male and female pediatric subjects clinically diagnosed with Tourette Syndrome.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Change From Baseline to Week 6 in the Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS)
Secondary Outcome
Clinical Global Impression of Tourette Syndrome (CGI-TS) - Improvement Score at Week 6
Condition
Tourette Syndrome
Intervention
NBI-98854
Study Arms / Comparison Groups
Placebo
Description: Administered once daily for 6 weeks
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
98
Start Date
March 23, 2016
Completion Date
April 14, 2017
Primary Completion Date
April 14, 2017
Eligibility Criteria
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
Gender
All
Ages
6 Years - 17 Years
Accepts Healthy Volunteers
No
Contacts
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Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02679079
Organization ID
NBI-98854-1501
Responsible Party
Sponsor
Study Sponsor
Neurocrine Biosciences
Study Sponsor
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Verification Date
December 2020