Phase 2 N=124 Randomized Quadruple-blind Treatment

Safety and Efficacy Study of NBI-98854 in Adults With Tourette Syndrome

Tourette Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT02581865 ↗

Enrolled (actual)

124

Serious AEs

3.2%

Results posted

May 2020

Primary outcome: Primary: Change From Baseline to Week 8 in the YGTSS TTS — -6.1; -7.4; -8.0 Least Squares Mean (Standard Error) — p=0.4326

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: NBI-98854 (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Neurocrine Biosciences
Primary completion: Dec 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to Week 8 in the YGTSS TTS	-6.1; -7.4; -8.0	0.4326
SECONDARY Clinical Global Impression of Change Tourette Syndrome (CGI-TS)-Improvement Score at Week 8	3.2; 3.0; 2.6	0.3812
SECONDARY Change From Baseline to Week 8 in the Clinical Global Impression of Tics (CGI-Tics)-Severity Score	-0.8; -1.0; -1.0	0.3065
SECONDARY Change From Baseline to Last Visit in the Rush Video-based Tic Rating Scale (RTRS) Total Score	-1.9; -3.0; -3.6	0.2215
SECONDARY Change From Baseline to Week 8 in the YGTSS Global Tic Severity Score	-15.0; -16.2; -19.1	0.5689
SECONDARY Change From Baseline to Week 8 in the Premonitory Urge for Tics Scale (PUTS) Total Score	-1.2; -0.8; -0.6	0.4515

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 8 weeks of treatment. This study will enroll approximately 90 male and female subjects clinically diagnosed with Tourette Syndrome.

Eligibility Criteria

Inclusion Criteria

Have a clinical diagnosis of Tourette Syndrome (TS)
Have at least moderate tic severity
Have TS symptoms that impair school, occupational, and/or social function
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
Have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, or opiates, 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 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 tachy-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 VMAT2 inhibitors
Have a known history of substance dependence, substance (drug) or alcohol abuse
Have a significant risk of suicidal or violent behavior
Are currently pregnant or breastfeeding
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
Have a blood loss ≥550 mL or donated blood within 30 days prior to screening

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02581865). 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.