Brief Title
Open-Label Safety and Tolerability Study of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome
Official Title
Open-Label Safety and Tolerability Study of Optimized Doses of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Condition
Tourette Syndrome
Intervention
Valbenazine
Study Arms / Comparison Groups
Valbenazine
Description: Valbenazine administered once daily for up to 24 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
85
Start Date
February 8, 2018
Completion Date
July 12, 2019
Primary Completion Date
July 12, 2019
Eligibility Criteria
Inclusion Criteria: 1. Have participated in and completed Study NBI-98854-TS2003 2. Have a clinical diagnosis of Tourette Syndrome (TS) 3. 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 4. Be in good general health 5. 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 6. 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 vesicular monoamine transporter 2 (VMAT2) inhibitors 6. Have a blood loss ≥250 mL or donated blood within 56 days prior to baseline 7. Have a known history of substance (drug) dependence, or substance or alcohol abuse 8. Have a significant risk of suicidal or violent behavior 9. 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 - 18 Years
Accepts Healthy Volunteers
No
Contacts
Clinical Development Lead, ,
Location Countries
Puerto Rico
Location Countries
Puerto Rico
Administrative Informations
NCT ID
NCT03444038
Organization ID
NBI-98854-TS2004
Responsible Party
Sponsor
Study Sponsor
Neurocrine Biosciences
Study Sponsor
Clinical Development Lead, Study Director, Neurocrine Biosciences
Verification Date
January 2022