Back to resultsNBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder
Primary Purpose
Tardive Dyskinesia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NBI-98854
NBI-98854
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Tardive Dyskinesia
Eligibility Criteria
Inclusion Criteria:
- Have a clinical diagnosis of schizophrenia or schizoaffective disorder and a clinical diagnosis of neuroleptic-induced tardive dyskinesia as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), 333.82 (see Appendix 17.1) 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 adequate hearing, vision, and language skills to perform the procedures specified in the protocol.
- 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.
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(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.
Sites / Locations
- Woodland International Research Group, Inc
- Synergy Clinical Research
- UCSD Outpatient Psychiatry
- PCSD - Feighner Research
- San Marcus Research Clinic, Inc.
- Medical Research Marseilles
- Scientific Clinical Research, Inc.
- Atlanta Center for Medical Research
- St. Louis Clinical Trials
- Clinical Trials of Texas, Inc.
- CAMC Clinical Trials Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
NBI-98854 12.5 mg
NBI-98854 50 mg
Arm Description
During the Cross-Over Study, subjects will be randomly assigned to receive one of the following treatment sequences: Sequence 1: Placebo once daily dose for Days 1-14 and 12.5 mg NBI-98854 once daily dose for Days 15-28. Sequence 2: 12.5 mg NBI-98854 once daily dose for Days 1-14 and placebo once daily dose for Days 15-28.
During the Cross-Over Study, subjects will be randomly assigned to receive one of the following treatment sequences: Sequence 3: Placebo once daily dose for Days 1-14 and 50 mg NBI-98854 once daily dose for Days 15-28. Sequence 4: 50 mg NBI-98854 once daily dose for Days 1-14 and placebo once daily dose for Days 15-28.
Outcomes
Primary Outcome Measures
Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score
Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by blinded central AIMS video raters. The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.
Secondary Outcome Measures
Clinical Global Impression - Global Improvement of TD (CGI-TD)
Clinician's perspective of the participant's overall improvement of TD symptoms over time. The CGI-TD is based on a 7-point scale (range: 1=very much improved to 7=very much worse).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01393600
Brief Title
NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder
Official Title
A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Two-Period Cross-Over 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
July 2017
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurocrine Biosciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of two doses (12.5 and 50 mg) of NBI-98854 administered once daily (q.d.) for the treatment of tardive dyskinesia in subjects with schizophrenia or schizoaffective disorder.
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
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NBI-98854 12.5 mg
Arm Type
Experimental
Arm Description
During the Cross-Over Study, subjects will be randomly assigned to receive one of the following treatment sequences:
Sequence 1: Placebo once daily dose for Days 1-14 and 12.5 mg NBI-98854 once daily dose for Days 15-28.
Sequence 2: 12.5 mg NBI-98854 once daily dose for Days 1-14 and placebo once daily dose for Days 15-28.
Arm Title
NBI-98854 50 mg
Arm Type
Experimental
Arm Description
During the Cross-Over Study, subjects will be randomly assigned to receive one of the following treatment sequences:
Sequence 3: Placebo once daily dose for Days 1-14 and 50 mg NBI-98854 once daily dose for Days 15-28.
Sequence 4: 50 mg NBI-98854 once daily dose for Days 1-14 and placebo once daily dose for Days 15-28.
Intervention Type
Drug
Intervention Name(s)
NBI-98854
Intervention Description
12.5 mg powder in bottle once daily for 14 days
Intervention Type
Drug
Intervention Name(s)
NBI-98854
Intervention Description
50 mg powder in bottle once daily for 14 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Solution containing no active substance
Primary Outcome Measure Information:
Title
Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score
Description
Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by blinded central AIMS video raters. The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.
Time Frame
Day 15 and 29, averaged
Secondary Outcome Measure Information:
Title
Clinical Global Impression - Global Improvement of TD (CGI-TD)
Description
Clinician's perspective of the participant's overall improvement of TD symptoms over time. The CGI-TD is based on a 7-point scale (range: 1=very much improved to 7=very much worse).
Time Frame
Day 15 and 29, averaged
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:
Have a clinical diagnosis of schizophrenia or schizoaffective disorder and a clinical diagnosis of neuroleptic-induced tardive dyskinesia as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), 333.82 (see Appendix 17.1) 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 adequate hearing, vision, and language skills to perform the procedures specified in the protocol.
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.
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(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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher O'Brien, MD
Organizational Affiliation
Neurocrine Biosciences
Official's Role
Study Director
Facility Information:
Facility Name
Woodland International Research Group, Inc
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Synergy Clinical Research
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
UCSD Outpatient Psychiatry
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
PCSD - Feighner Research
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
San Marcus Research Clinic, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33015
Country
United States
Facility Name
Medical Research Marseilles
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Scientific Clinical Research, Inc.
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
St. Louis Clinical Trials
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63118
Country
United States
Facility Name
Clinical Trials of Texas, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
CAMC Clinical Trials Center
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
12. IPD Sharing Statement
Learn more about this trial
NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder
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