Phase 2 N=155 Treatment

Safety and Tolerability Study of NBI-98854 for the Treatment of Subjects With Tourette Syndrome

Tourette Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT02879578 ↗

Enrolled (actual)

155

Serious AEs

1.3%

Results posted

Apr 2021

Primary outcome: Primary: Frequency of Treatment-emergent Adverse Events (TEAEs) — 20; 29; 68 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Valbenazine (Drug)
Age: Pediatric, Adult · 6+ yrs
Sex: All
Sponsor: Neurocrine Biosciences
Primary completion: Nov 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Frequency of Treatment-emergent Adverse Events (TEAEs)	20; 29; 68	—

Summary

Phase 2, open-label, fixed-dose titration study to evaluate the safety and tolerability of NBI-98854 administered once daily for a total of 24 weeks in children, adolescents, and adults with Tourette Syndrome (TS).

Eligibility Criteria

Inclusion Criteria

Have participated in and completed the NBI-98854-1501 (T-Force Green) or NBI-98854-1505 (T-Forward) Phase 2 study
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
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
Adolescent and adult subjects (12 to 64 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 who are on stable doses of prescribed and supervised (not as needed) benzodiazepines, opiates, or psychostimulants (for subjects with comorbid ADHD) are allowed to participate in the study
Be in good general health

Exclusion Criteria

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 a blood loss ≥250 mL or donated blood within 56 days prior to screening (subjects 6 to 17 years of age); have a blood loss ≥550 mL or donated blood within 30 days prior to screening (subjects 18 to 64 years of age)
Have a known history of substance dependence, substance (drug) or alcohol abuse
Have a significant risk of suicidal or violent behavior
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02879578). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.