Efficacy and Safety of NBI-98854 in Subjects With Tardive Dyskinesia

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety and efficacy of three doses (12.5, 25, and 50 mg) of NBI-98854 for the treatment of the symptoms of tardive dyskinesia (TD) in subjects with schizophrenia or schizoaffective disorder.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neurocrine Biosciences

Criteria

Inclusion Criteria:

• Males or females (non-childbearing potential) aged 18 to 65 years (both inclusive).

• Have moderate or severe Tardive Dyskinesia symptoms (Total AIMS score of at least 9)

• Have a clinical diagnosis of schizophrenia or schizoaffective disorder.

• Receiving a stable dose of antipsychotic medication for a minimum of 30 days or have stable psychiatric status.

• Doses of concurrent medications and the conditions being treated have been stable for a minimum of 30 days and expected to remain stable during the study.

• Are in good general health and expected to complete the clinical study as designed.

• Have a body mass index (BMI) of 18 to 38 kg/m^2.

• Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.

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.

• Have a known history of neuroleptic malignant syndrome.

• Have a significant risk of suicidal or violent behavior.

• Receiving medication for the treatment of Tardive Dyskinesia

• Receiving any excluded concomitant medication as specified in the protocol.