Safety and Tolerability Study of NBI-98854 for the Treatment of Subjects With Tourette Syndrome
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome; Syndrome
Intervention: Valbenazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 155.0
Sex: All
Minimum age: 6 Years
Maximum age: 64 Years
Healthy volunteers: No

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