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Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive Dyskinesia (Kinect 4)

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ClinicalTrials.gov Identifier: NCT02405091
Recruitment Status : Completed
First Posted : April 1, 2015
Results First Posted : November 30, 2018
Last Update Posted : November 30, 2018
Sponsor:
Information provided by (Responsible Party):
Neurocrine Biosciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Tardive Dyskinesia Drug: NBI-98854 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 167 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Open-Label, Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive Dyskinesia
Study Start Date : March 2015
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Valbenazine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose Group 1
Fixed dose of NBI-98854 administered once daily for 48 weeks
 Drug: NBI-98854
Experimental: Dose Group 2
Fixed dose of NBI-98854 administered once daily up to 48 weeks
 Drug: NBI-98854


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants Monitored for Long-Term Safety of Valbenazine [ Time Frame: 52 weeks ]
    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 :
  1. 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 [ Time Frame: Baseline and Week 48 ]
    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.

  2. Severity of Tardive Dyskinesia (TD) Symptoms Assessed by Abnormal Involuntary Movements Scale (AIMS) Dyskinesia Total Score Change From Baseline; Central AIMS Video Raters [ Time Frame: Baseline, Change from Baseline at Week 8, and Change from Baseline at Week 52 ]
    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.

  3. Severity of Tardive Dyskinesia (TD) Symptoms Assessed by Abnormal Involuntary Movements Scale (AIMS) Dyskinesia Total Score Change From Baseline; On-Site AIMS Raters [ Time Frame: Baseline, Change from Baseline at Week 8, and Change from Baseline at Week 52 ]
    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.

  4. Clinical Global Impression - Global Improvement of Tardive Dyskinesia (CGI-TD) at Week 48 [ Time Frame: 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).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Female subjects must not be pregnant.
  3. Have one of the following clinical diagnoses for at least 3 months prior to screening: Schizophrenia or Schizoaffective Disorder, or Mood Disorder
  4. Have a clinical diagnosis of neuroleptic-induced TD for at least 3 months prior to screening.
  5. Have moderate or severe TD
  6. If using maintenance medication(s) for schizophrenia or schizoaffective disorder, or mood disorder, be on stable doses.
  7. Be in general good health.
  8. Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.
  9. Have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids.

Exclusion Criteria

  1. Have an active, clinically significant unstable medical condition within 1 month prior to screening.
  2. Have a known history of substance dependence, substance (drug) or alcohol abuse.
  3. Have a significant risk of suicidal or violent behavior.
  4. Have a known history of neuroleptic malignant syndrome.
  5. Have a known history of long QT syndrome or cardiac tachy-arrhythmia.
  6. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed).
  7. Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study.
  8. Have a blood loss ≥550 mL or donated blood within 30 days prior to Baseline.
  9. Have an allergy, hypersensitivity, or intolerance to tetrabenazine.
  10. Are currently pregnant or breastfeeding.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02405091


Locations
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United States, California
Anaheim, California, United States
Glendale, California, United States
Irvine, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Oakland, California, United States
San Bernardino, California, United States
San Diego, California, United States
Torrance, California, United States
United States, Delaware
Hockessin, Delaware, United States
United States, Florida
Bradenton, Florida, United States
Hialeah, Florida, United States
Kissimmee, Florida, United States
Miami, Florida, United States
North Miami, Florida, United States
Orlando, Florida, United States
United States, Hawaii
Honolulu, Hawaii, United States
United States, Illinois
Chicago, Illinois, United States
United States, Louisiana
Shreveport, Louisiana, United States
United States, Massachusetts
Natick, Massachusetts, United States
Worcester, Massachusetts, United States
United States, Michigan
Ann Arbor, Michigan, United States
United States, Missouri
Saint Louis, Missouri, United States
United States, Nebraska
Lincoln, Nebraska, United States
Omaha, Nebraska, United States
United States, New Hampshire
Nashua, New Hampshire, United States
United States, New York
Buffalo, New York, United States
New York, New York, United States
Rochester, New York, United States
United States, North Carolina
High Point, North Carolina, United States
United States, Ohio
Dayton, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Conshohocken, Pennsylvania, United States
Norristown, Pennsylvania, United States
Phoenixville, Pennsylvania, United States
Scranton, Pennsylvania, United States
United States, Texas
DeSoto, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Irving, Texas, United States
United States, Virginia
Petersburg, Virginia, United States
United States, Washington
Seattle, Washington, United States
Spokane, Washington, United States
Canada, British Columbia
Vancouver, British Columbia, Canada
Canada, Ontario
London, Ontario, Canada
Toronto, Ontario, Canada
Canada, Quebec
Montreal, Quebec, Canada
Puerto Rico
San Juan, Puerto Rico
Sponsors and Collaborators
Neurocrine Biosciences
  Study Documents (Full-Text)

Documents provided by Neurocrine Biosciences:
Study Protocol  [PDF] December 3, 2015
Statistical Analysis Plan  [PDF] April 5, 2016

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Neurocrine Biosciences
ClinicalTrials.gov Identifier: NCT02405091    
Other Study ID Numbers: NBI-98854-1402
First Posted: April 1, 2015    Key Record Dates
Results First Posted: November 30, 2018
Last Update Posted: November 30, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
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Dyskinesias
Tardive Dyskinesia
Movement Disorders
Central Nervous System Diseases
 Nervous System Diseases
Neurologic Manifestations
Dyskinesia, Drug-Induced