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

Completed · Phase 2 · Has a placebo group

Conditions studied: Tardive Dyskinesia

In brief

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.

Key facts

Study ID

NCT01688037

Run by

Neurocrine Biosciences

People needed

109

Starts

2012-09-01

Expected to finish

2013-10-01

Last updated by the study team

2017-11-08

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Anaheim, California, United States
• Study site — Carson, California, United States
• Study site — Colton, California, United States
• Study site — Costa Mesa, California, United States
• Study site — Downey, California, United States
• Study site — Fountain Valley, California, United States
• Study site — Glendale, California, United States
• Study site — National City, California, United States
• Study site — Oceanside, California, United States
• Study site — Paramount, California, United States
• Study site — San Bernardino, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — Santa Ana, California, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Hialeah, Florida, United States
• Study site — Lauderhill, Florida, United States
• Study site — Melbourne, Florida, United States
• Study site — Miami Springs, Florida, United States
• Study site — North Miami, Florida, United States
• Study site — Orange City, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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