NBI-98854 Dose Titration Study for the Treatment of Tardive Dyskinesia

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 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.

Key facts

Study ID

NCT01733121

Run by

Neurocrine Biosciences

People needed

102

Starts

2012-12-01

Expected to finish

2013-12-01

Last updated by the study team

2017-08-10

Who can join

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

You may qualify if…

• 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.

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 — Costa Mesa, California, United States
• Study site — Fountain Valley, California, United States
• Study site — Oceanside, California, United States
• Study site — Englewood, Colorado, United States
• Study site — Boca Raton, Florida, United States
• Study site — Hialeah, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Baltimore, Maryland, United States
• Study site — Farmington Hills, Michigan, United States
• Study site — Beachwood, Ohio, United States
• Study site — Middleburg Heights, Ohio, United States
• Study site — Conshohocken, Pennsylvania, United States
• Study site — Phoenixville, Pennsylvania, United States
• Study site — Bedford, Texas, United States
• Study site — DeSoto, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Irving, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Richland, Washington, United States
• Study site — Caguas, Puerto Rico

Full record on ClinicalTrials.gov

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