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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
37
Woodland International Research Group, Inc
Little Rock, Arkansas, United States
Synergy Clinical Research
National City, California, United States
UCSD Outpatient Psychiatry
San Diego, California, United States
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.
Time frame: Day 15 and 29, averaged
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).
Time frame: Day 15 and 29, averaged
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
PCSD - Feighner Research
San Diego, California, United States
San Marcus Research Clinic, Inc.
Miami, Florida, United States
Medical Research Marseilles
Miami, Florida, United States
Scientific Clinical Research, Inc.
North Miami, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
St. Louis Clinical Trials
St Louis, Missouri, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
...and 1 more locations