Status:
COMPLETED
Open-Label Safety and Tolerability Study of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome
Lead Sponsor:
Neurocrine Biosciences
Conditions:
Tourette Syndrome
Eligibility:
All Genders
6-18 years
Phase:
PHASE2
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 Syndr...
Eligibility Criteria
Inclusion
- Have participated in and completed Study NBI-98854-TS2003
- Have a clinical diagnosis of Tourette Syndrome (TS)
- 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
- 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
- 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
- Have an active, clinically significant unstable medical condition within 1 month prior to 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 vesicular monoamine transporter 2 (VMAT2) inhibitors
- Have a blood loss ≥250 mL or donated blood within 56 days prior to baseline
- Have a known history of substance (drug) dependence, or substance or alcohol abuse
- Have a significant risk of suicidal or violent behavior
- Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study
Key Trial Info
Start Date :
February 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 12 2019
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT03444038
Start Date
February 8 2018
End Date
July 12 2019
Last Update
February 23 2022
Active Locations (37)
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1
Neurocrine Clinical Site
Sun City, Arizona, United States, 85351
2
Neurocrine Clinical Site
Anaheim, California, United States, 92805
3
Neurocrine Clinical Site
San Diego, California, United States, 92108
4
Neurocrine Clinical Site
Santa Ana, California, United States, 92705