search
Back to results

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

Primary Purpose

Tardive Dyskinesia

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
NBI-98854
Sponsored by
Neurocrine Biosciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tardive Dyskinesia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NBI-98854

Arm Description

Open-label, dose titration of active drug

Outcomes

Primary Outcome Measures

Assessment of Tardive Dyskinesia symptoms
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
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
Blood samples will be collected and analyzed to evaluate drug and metabolite plasma concentrations.

Full Information

First Posted
December 21, 2010
Last Updated
April 18, 2011
Sponsor
Neurocrine Biosciences
search

1. Study Identification

Unique Protocol Identification Number
NCT01267188
Brief Title
Efficacy and Safety of NBI-98854 in Subjects With Tardive Dyskinesia
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 Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Neurocrine Biosciences

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tardive Dyskinesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NBI-98854
Arm Type
Experimental
Arm Description
Open-label, dose titration of active drug
Intervention Type
Drug
Intervention Name(s)
NBI-98854
Intervention Description
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
Primary Outcome Measure Information:
Title
Assessment of Tardive Dyskinesia symptoms
Description
Abnormal Involuntary Movements Scale (AIMS) and Clinical Global Impression - Global Improvement of TD (CGI-TD) scale
Time Frame
19 days
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events following dosing with NBI-98854
Description
Outcome assessment includes monitoring of: Adverse events Clinical laboratory tests Vital signs Physical examinations 12-lead electrocardiogram (ECG)
Time Frame
19 days
Title
Evaluate pharmacokinetics of three doses of NBI-98854
Description
Blood samples will be collected and analyzed to evaluate drug and metabolite plasma concentrations.
Time Frame
19 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 1R8
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs