NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder (KINECT Study)
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder
1 other identifier
interventional
109
2 countries
51
Brief Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of two doses (50 and 100 mg) of NBI-98854 administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2012
Shorter than P25 for phase_2
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 11, 2012
CompletedFirst Posted
Study publicly available on registry
September 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedResults Posted
Study results publicly available
November 8, 2017
CompletedNovember 8, 2017
October 1, 2017
1 year
September 11, 2012
May 11, 2017
October 9, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 6
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. The primary efficacy endpoint was the change from baseline in the AIMS dyskinesia total score at Week 6 between the pooled NBI-98854 50+100 mg group and placebo group analyzed using the ANCOVA model (LOCF, ITT analysis set).
Baseline and Week 6
Secondary Outcomes (2)
Clinical Global Impression - Global Improvement of TD (CGI-TD)
Week 6
Clinical Global Impression - Global Improvement of TD (CGI-TD) at Week 2
Week 2
Study Arms (3)
NBI-98854 50 mg
EXPERIMENTALNBI-98854 50 mg administered as two (2) 25 mg capsules by mouth, taken every morning between 7:00am - 10:00am for 6 weeks.
NBI-98854 100 mg and 50 mg
EXPERIMENTALNBI-98854 100 mg administered as two (2) 50 mg capsules taken every morning between 7:00am - 10:00am for 2 weeks. After 2 weeks, NBI-98854 50 mg administered by two (2) 25 mg capsules by mouth, taken every morning between 7:00am - 10:00am for remaining 4 weeks.
Placebo
PLACEBO COMPARATORCapsule containing no active substance, manufactured to mimic NBI-98854 25 mg and 50 mg capsules.
Interventions
Eligibility Criteria
You may qualify if:
- Have a clinical diagnosis of schizophrenia or schizoaffective disorder and a clinical diagnosis of neuroleptic-induced tardive dyskinesia 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 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.
You may not qualify if:
- Have an active clinically significant unstable medical condition within 1 month (30 days) prior to screening.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
Unknown Facility
Little Rock, Arkansas, 72211, United States
Unknown Facility
Anaheim, California, 92804, United States
Unknown Facility
Carson, California, 90746, United States
Unknown Facility
Colton, California, 92324, United States
Unknown Facility
Costa Mesa, California, 92626, United States
Unknown Facility
Downey, California, 90241, United States
Unknown Facility
Fountain Valley, California, 92708, United States
Unknown Facility
Glendale, California, 91206, United States
Unknown Facility
National City, California, 91950, United States
Unknown Facility
Oceanside, California, 92056, United States
Unknown Facility
Paramount, California, 90723, United States
Unknown Facility
San Bernardino, California, 92408, United States
Unknown Facility
San Diego, California, 92103, United States
Unknown Facility
San Diego, California, 92108, United States
Unknown Facility
San Diego, California, 92121, United States
Unknown Facility
San Diego, California, 92123, United States
Unknown Facility
Santa Ana, California, 92705, United States
Unknown Facility
Fort Lauderdale, Florida, 33334, United States
Unknown Facility
Hialeah, Florida, 33012, United States
Unknown Facility
Lauderhill, Florida, 33319, United States
Unknown Facility
Melbourne, Florida, 32901, United States
Unknown Facility
Miami Springs, Florida, 33166, United States
Unknown Facility
North Miami, Florida, 33161, United States
Unknown Facility
Orange City, Florida, 32763, United States
Unknown Facility
Atlanta, Georgia, 30342, United States
Unknown Facility
Chicago, Illinois, 60612, United States
Unknown Facility
Chicago, Illinois, 60640, United States
Unknown Facility
Schaumburg, Illinois, 60194, United States
Unknown Facility
New Orleans, Louisiana, 70114, United States
Unknown Facility
Shreveport, Louisiana, 71104, United States
Unknown Facility
Baltimore, Maryland, 21285, United States
Unknown Facility
Glen Burnie, Maryland, 21061, United States
Unknown Facility
St Louis, Missouri, 63118, United States
Unknown Facility
St Louis, Missouri, 63141, United States
Unknown Facility
Toms River, New Jersey, 08755, United States
Unknown Facility
Albany, New York, 12208, United States
Unknown Facility
Brooklyn, New York, 11203, United States
Unknown Facility
Wards Island, New York, 10035, United States
Unknown Facility
Hope Mills, North Carolina, 28348, United States
Unknown Facility
Beachwood, Ohio, 44122, United States
Unknown Facility
Oklahoma City, Oklahoma, 73112, United States
Unknown Facility
Conshohocken, Pennsylvania, 19428, United States
Unknown Facility
Charleston, South Carolina, 29407, United States
Unknown Facility
Memphis, Tennessee, 38119, United States
Unknown Facility
DeSoto, Texas, 75115, United States
Unknown Facility
Irving, Texas, 75062, United States
Unknown Facility
Bothell, Washington, 98011, United States
Unknown Facility
Kirkland, Washington, 98033, United States
Unknown Facility
Spokane, Washington, 99204, United States
Unknown Facility
Caguas, 00725, Puerto Rico
Unknown Facility
San Juan, 00927, Puerto Rico
Related Publications (1)
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.
PMID: 31617235DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Neurocrine Medical Information
- Organization
- Neurocrine Biosciences, Inc.
Study Officials
- STUDY DIRECTOR
Chris O'Brien, MD
Neurocrine Biosciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2012
First Posted
September 19, 2012
Study Start
September 1, 2012
Primary Completion
September 1, 2013
Study Completion
October 1, 2013
Last Updated
November 8, 2017
Results First Posted
November 8, 2017
Record last verified: 2017-10