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

Tardive Dyskinesia Clinical Trial

Official title:

A Phase 2, Open-Label, Dose Titration Study to Evaluate the Efficacy and Safety of NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01267188
• Other study ID #: NBI-98854-1001
• Status: Completed
• Phase: Phase 2
• First received: December 21, 2010
• Last updated: April 18, 2011
• Start date: January 2011
• Est. completion date: March 2011

Study information

• Verified date: April 2011
• Source: Neurocrine Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a Phase 2, open-label, dose titration study to assess the efficacy and safety of three once daily (q.d.) doses (12.5, 25, and 50 mg) of NBI-98854 administered once daily for up to 12 days consisting of three treatment periods of 4 days each (Periods 1, 2, and 3). The starting dose will be 12.5 mg q.d. (Period 1), and this dose will be escalated to 25 mg q.d. (Period 2) and then to 50 mg q.d. (Period 3) based upon each subject's ability to tolerate NBI-98854. Progression to the next dose level will be based upon the subject's ability to tolerate the previous dose and the Investigator's review of adverse events and safety data. For subjects who do not tolerate a dose increase, the dose may be decreased to the dose that was previously administered (i.e., 25 mg to 12.5 mg, 50 mg to 25 mg) and continued at that dose for the remainder of the study treatment. Up to 10 medically stable subjects with schizophrenia or schizoaffective disorder who have moderate or severe symptoms of TD will be enrolled as outpatients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyskinesias
• Tardive Dyskinesia

Intervention

Drug:
• NBI-98854
powder in bottle, prepared doses at 12.5, 25, and 50 mg q.d. administered for up to 12 days consisting of three treatment periods of 4 days each

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Neurocrine Biosciences

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Tardive Dyskinesia symptoms	Abnormal Involuntary Movements Scale (AIMS) and Clinical Global Impression - Global Improvement of TD (CGI-TD) scale	19 days
Secondary	Number of Participants with Adverse Events following dosing with NBI-98854	Outcome assessment includes monitoring of: Adverse events; Clinical laboratory tests; Vital signs; Physical examinations; 12-lead electrocardiogram (ECG)	19 days
Secondary	Evaluate pharmacokinetics of three doses of NBI-98854	Blood samples will be collected and analyzed to evaluate drug and metabolite plasma concentrations.	19 days