Back to resultsSafety and Tolerability Study of NBI-98854 for the Treatment of Tardive Dyskinesia (Kinect 4)
Primary Purpose
Tardive Dyskinesia
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
NBI-98854
Sponsored by
About this trial
This is an interventional treatment trial for Tardive Dyskinesia
Eligibility Criteria
Inclusion Criteria:
- Subjects of childbearing potential must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment and follow-up periods of the study.
- Female subjects must not be pregnant.
- Have one of the following clinical diagnoses for at least 3 months prior to screening: Schizophrenia or Schizoaffective Disorder, or Mood Disorder
- Have a clinical diagnosis of neuroleptic-induced TD for at least 3 months prior to screening.
- Have moderate or severe TD
- If using maintenance medication(s) for schizophrenia or schizoaffective disorder, or mood disorder, be on stable doses.
- Be in general good health.
- Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.
- Have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids.
Exclusion Criteria
- Have an active, clinically significant unstable medical condition within 1 month prior to screening.
- Have a known history of substance dependence, substance (drug) or alcohol abuse.
- Have a significant risk of suicidal or violent behavior.
- Have a known history of neuroleptic malignant syndrome.
- Have a known history of long QT syndrome or cardiac tachy-arrhythmia.
- Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed).
- 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 a blood loss ≥550 mL or donated blood within 30 days prior to Baseline.
- Have an allergy, hypersensitivity, or intolerance to tetrabenazine.
- Are currently pregnant or breastfeeding.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Dose Group 1
Dose Group 2
Arm Description
Fixed dose of NBI-98854 administered once daily for 48 weeks
Fixed dose of NBI-98854 administered once daily up to 48 weeks
Outcomes
Primary Outcome Measures
Number of Participants Monitored for Long-Term Safety of Valbenazine
Number of participants monitored for long-term safety through reporting of treatment-emergent adverse events and monitoring of vital signs, clinical laboratory values, and ECG. Summaries of all treatment-emergent AEs, treatment-related AEs, SAEs, and AEs leading to study drug discontinuation were prepared.
Secondary Outcome Measures
Severity of Tardive Dyskinesia (TD) Symptoms Assessed by Abnormal Involuntary Movements Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 48; On-site AIMS Raters
Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by On-Site 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.
Severity of Tardive Dyskinesia (TD) Symptoms Assessed by Abnormal Involuntary Movements Scale (AIMS) Dyskinesia Total Score Change From Baseline; Central AIMS Video Raters
Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by the 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.
Severity of Tardive Dyskinesia (TD) Symptoms Assessed by Abnormal Involuntary Movements Scale (AIMS) Dyskinesia Total Score Change From Baseline; On-Site AIMS Raters
Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by On-Site AIMS 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.
Clinical Global Impression - Global Improvement of Tardive Dyskinesia (CGI-TD) at Week 48
Clinician's perspective of the participant's overall improvement of TD symptoms since initiation of study drug dosing. The CGI-TD is based on a 7-point scale (range: 1=very much improved to 7=very much worse).
Full Information
NCT ID
NCT02405091
First Posted
March 27, 2015
Last Updated
November 29, 2018
Sponsor
Neurocrine Biosciences
1. Study Identification
Unique Protocol Identification Number
NCT02405091
Brief Title
Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive Dyskinesia
Acronym
Kinect 4
Official Title
A Phase 3, Open-Label, Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive Dyskinesia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (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
Phase 3, open-label, study to evaluate the safety and tolerability of NBI-98854 administered once daily (qd) for a total of 48 weeks of treatment. This study will enroll approximately 150 medically stable male and female subjects with clinical diagnoses of schizophrenia or schizoaffective disorder with neuroleptic-induced TD or mood disorder with neuroleptic-induced TD.
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 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
167 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dose Group 1
Arm Type
Experimental
Arm Description
Fixed dose of NBI-98854 administered once daily for 48 weeks
Arm Title
Dose Group 2
Arm Type
Experimental
Arm Description
Fixed dose of NBI-98854 administered once daily up to 48 weeks
Intervention Type
Drug
Intervention Name(s)
NBI-98854
Primary Outcome Measure Information:
Title
Number of Participants Monitored for Long-Term Safety of Valbenazine
Description
Number of participants monitored for long-term safety through reporting of treatment-emergent adverse events and monitoring of vital signs, clinical laboratory values, and ECG. Summaries of all treatment-emergent AEs, treatment-related AEs, SAEs, and AEs leading to study drug discontinuation were prepared.
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Severity of Tardive Dyskinesia (TD) Symptoms Assessed by Abnormal Involuntary Movements Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 48; On-site AIMS Raters
Description
Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by On-Site 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
Baseline and Week 48
Title
Severity of Tardive Dyskinesia (TD) Symptoms Assessed by Abnormal Involuntary Movements Scale (AIMS) Dyskinesia Total Score Change From Baseline; Central AIMS Video Raters
Description
Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by the 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
Baseline, Change from Baseline at Week 8, and Change from Baseline at Week 52
Title
Severity of Tardive Dyskinesia (TD) Symptoms Assessed by Abnormal Involuntary Movements Scale (AIMS) Dyskinesia Total Score Change From Baseline; On-Site AIMS Raters
Description
Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by On-Site AIMS 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
Baseline, Change from Baseline at Week 8, and Change from Baseline at Week 52
Title
Clinical Global Impression - Global Improvement of Tardive Dyskinesia (CGI-TD) at Week 48
Description
Clinician's perspective of the participant's overall improvement of TD symptoms since initiation of study drug dosing. The CGI-TD is based on a 7-point scale (range: 1=very much improved to 7=very much worse).
Time Frame
Week 48
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects of childbearing potential must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment and follow-up periods of the study.
Female subjects must not be pregnant.
Have one of the following clinical diagnoses for at least 3 months prior to screening: Schizophrenia or Schizoaffective Disorder, or Mood Disorder
Have a clinical diagnosis of neuroleptic-induced TD for at least 3 months prior to screening.
Have moderate or severe TD
If using maintenance medication(s) for schizophrenia or schizoaffective disorder, or mood disorder, be on stable doses.
Be in general good health.
Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.
Have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids.
Exclusion Criteria
Have an active, clinically significant unstable medical condition within 1 month prior to screening.
Have a known history of substance dependence, substance (drug) or alcohol abuse.
Have a significant risk of suicidal or violent behavior.
Have a known history of neuroleptic malignant syndrome.
Have a known history of long QT syndrome or cardiac tachy-arrhythmia.
Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed).
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 a blood loss ≥550 mL or donated blood within 30 days prior to Baseline.
Have an allergy, hypersensitivity, or intolerance to tetrabenazine.
Are currently pregnant or breastfeeding.
Facility Information:
City
Anaheim
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California
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United States
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Glendale
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Irvine
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Phoenixville
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Scranton
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DeSoto
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Houston
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Irving
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London
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Toronto
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Montreal
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San Juan
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Puerto Rico
12. IPD Sharing Statement
Citations:
PubMed Identifier
31617235
Citation
Sajatovic M, Alexopoulos GS, Burke J, Farahmand K, Siegert S. The effects of valbenazine on tardive dyskinesia in older and younger patients. Int J Geriatr Psychiatry. 2020 Jan;35(1):69-79. doi: 10.1002/gps.5218. Epub 2019 Oct 31.
Results Reference
derived
PubMed Identifier
28839341
Citation
Josiassen RC, Kane JM, Liang GS, Burke J, O'Brien CF. Long-Term Safety and Tolerability of Valbenazine (NBI-98854) in Subjects with Tardive Dyskinesia and a Diagnosis of Schizophrenia or Mood Disorder. Psychopharmacol Bull. 2017 Aug 1;47(3):61-68.
Results Reference
derived
Learn more about this trial
Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive Dyskinesia
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