Overview

NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder (KINECT Study)

Status:
Completed
Trial end date:
2013-10-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of two doses (50 and 100 mg) of NBI-98854 administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Neurocrine Biosciences
Treatments:
Tetrabenazine
Criteria
Inclusion Criteria:

- Have a clinical diagnosis of schizophrenia or schizoaffective disorder and 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.