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

Sponsor

Neurocrine Biosciences (Industry)

Overall Status

Completed

CT.gov ID

NCT01267188

Collaborator

(none)

Enrollment

Location

Arm

1.9

Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Tardive Dyskinesia	Drug: NBI-98854	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Mar 1, 2011

Actual Study Completion Date :

Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NBI-98854 Open-label, dose titration of active drug	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

Arm

Intervention/Treatment

Experimental: NBI-98854

Open-label, dose titration of active drug

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

Outcome Measures

Primary Outcome Measures

Assessment of Tardive Dyskinesia symptoms [19 days]
Abnormal Involuntary Movements Scale (AIMS) and Clinical Global Impression - Global Improvement of TD (CGI-TD) scale

Secondary Outcome Measures

Number of Participants with Adverse Events following dosing with NBI-98854 [19 days]
Outcome assessment includes monitoring of: Adverse events Clinical laboratory tests Vital signs Physical examinations 12-lead electrocardiogram (ECG)
Evaluate pharmacokinetics of three doses of NBI-98854 [19 days]
Blood samples will be collected and analyzed to evaluate drug and metabolite plasma concentrations.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Toronto	Ontario	Canada	M5T 1R8

Sponsors and Collaborators

Neurocrine Biosciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01267188

Other Study ID Numbers:

NBI-98854-1001

First Posted:

Dec 28, 2010

Last Update Posted:

Apr 20, 2011

Last Verified:

Apr 1, 2011

Additional relevant MeSH terms:

Dyskinesias

Tardive Dyskinesia

Study Results

No Results Posted as of Apr 20, 2011