NBI-98854 Dose Titration Study for the Treatment of Tardive Dyskinesia
Condition: Tardive Dyskinesia
MeSH terms: Dyskinesias; Tardive Dyskinesia
Intervention: NBI-98854; NBI-98854; Placebo
Intervention description: 25 mg capsule; 50 mg capsule
Intervention MeSH terms: Tetrabenazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy, safety, and tolerability of NBI-98854
      (titrated to a subject's optimal dose in the range of 25 to 75 mg) administered once daily
      for the treatment of Tardive Dyskinesia (TD) symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have one of the following clinical diagnoses for at least 3 months prior to screening
             a) schizophrenia or schizoaffective disorder; b) mood disorder; or c) gastrointestinal
             disorder (e.g., gastroparesis, gastroesophageal reflux disease)

          -  Have a clinical diagnosis of neuroleptic-induced tardive dyskinesia for at least 3
             months prior to screening.

          -  Be receiving a stable dose of antipsychotic medication for a minimum of 30 days before
             study start. Subjects who are not using antipsychotic medication must have stable
             psychiatric status.

          -  Have the doses of concurrent medications and the conditions being treated be stable
             for a minimum of 30 days before study start and be expected to remain stable during
             the study.

          -  Subjects of childbearing potential must agree to use hormonal or two forms of
             nonhormonal birth control during the study.

          -  Female subjects must not be pregnant.

          -  Be in good general health and expected to complete the clinical study as designed.

          -  Have a body mass index (BMI) of 18 to 38 kg/m2 (both inclusive).

          -  Have a negative urine drug screen (negative for amphetamines, barbiturates,
             benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids) at screening and
             study start, except for any subject receiving a stable dose of benzodiazepine.

          -  Have a negative alcohol breath test at screening and study start.

        Exclusion Criteria:

          -  Have an active clinically significant unstable medical condition within 1 month (30
             days) prior to screening.

          -  Have a history of substance dependence or substance (drug) or alcohol abuse within the
             3 months before study start(nicotine and caffeine dependence are not exclusionary).

          -  Have a known history of neuroleptic malignant syndrome.

          -  Have a significant risk of suicidal or violent behavior.

          -  Receiving any excluded concomitant medication such as reserpine, metoclopramide,
             stimulants, or tetrabenazine.

          -  Receiving medication for the treatment of tardive dyskinesia.

          -  Have a positive human immunodeficiency virus antibody, (HIV-Ab), hepatitis B surface
             antigen (HBsAg), or hepatitis C virus (HCV) antibody result at screening or have a
             history of positive result.

          -  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 an allergy, hypersensitivity, or intolerance to tetrabenazine.

          -  Have had previous exposure with NBI-98854.