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Persistence of Effect and Safety of Valbenazine for the Treatment of Tardive Dyskinesia

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ClinicalTrials.gov Identifier: NCT03891862
Recruitment Status : Completed
First Posted : March 27, 2019
Results First Posted : March 10, 2021
Last Update Posted : March 10, 2021
Sponsor:
Information provided by (Responsible Party):
Neurocrine Biosciences

Brief Summary:
This is a Phase 4, randomized, double-blind, placebo-controlled study to evaluate the persistence of effect of valbenazine 40 mg and 80 mg.

Condition or disease Intervention/treatment Phase
Tardive Dyskinesia (TD) Drug: Valbenazine Drug: Placebo oral capsule Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 4, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Evaluate the Persistence of Effect and Safety of Valbenazine for the Treatment of Tardive Dyskinesia
Actual Study Start Date : March 18, 2019
Actual Primary Completion Date : December 23, 2019
Actual Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Valbenazine

Arm Intervention/treatment
Experimental: Open-label Valbenazine
Participants received valbenazine 40 mg once daily for 1 week, then 80 mg once daily for the remainder of the 8-week open label period.
Drug: Valbenazine
vesicular monoamine transporter 2 (VMAT2) inhibitor
Other Name: Ingrezza, NBI-98854

Placebo Comparator: Placebo-controlled Placebo
Participants received placebo (matching valbenazine) once daily for 8 weeks. Randomization into this arm occurred after open-label treatment with valbenazine once daily for 8 weeks.
Drug: Placebo oral capsule
non-active dosage form

Experimental: Placebo-controlled Valbenazine
Participants received valbenazine 80 mg once daily for 8 weeks. Randomization into this arm occurred after open-label treatment with valbenazine once daily for 8 weeks.
Drug: Valbenazine
vesicular monoamine transporter 2 (VMAT2) inhibitor
Other Name: Ingrezza, NBI-98854




Primary Outcome Measures :
  1. Change From Randomization (Week 8) in Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score at Week 16 [ Time Frame: Week 8, Week 16 ]
    The AIMS rates 10 items of involuntary movement, each item ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Items assess facial, oral, extremity, and trunk movements, as well as self-awareness of abnormal movements. The AIMS Dyskinesia Total Score is the sum of items 1-7 and ranges from 0 to 28, with higher scores indicating more severe dyskinesia. Least-squares mean were estimated using a mixed-effects model for repeated measures.


Secondary Outcome Measures :
  1. Change From Baseline in the EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) Health State Index Score at Week 16 [ Time Frame: Baseline, Week 16 ]
    The EQ-5D-5L assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The health state index score is based on the results of the individual health profiles using the United States value set and ranges from -0.573 to 1.0, with higher scores indicating higher health utility.

  2. Change From Baseline in the EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) at Week 16 [ Time Frame: Baseline, Week 16 ]
    The EQ-5D-5L assesses general health-related quality of life. The second portion of the scale is a self-perceived health score assessed using a VAS that ranges from 0 ("the worst imaginable health") to 100 ("the best imaginable health").



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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. Have one of the following clinical diagnoses for at least 3 months before screening: Schizophrenia, Schizoaffective Disorder, or Mood Disorder
  3. Have a clinical diagnosis of neuroleptic-induced TD for at least 3 months before screening.
  4. Be on stable doses if using maintenance medication(s) for schizophrenia or schizoaffective disorder, or mood disorder. Subjects with bipolar disorder must be on stable doses of a mood stabilizer.
  5. Be in general good health.
  6. Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.

Exclusion Criteria:

  1. Have an active, clinically significant unstable medical condition within 1 month before screening.
  2. Have a known history of substance (drug) dependence, or substance or alcohol abuse.
  3. Have a significant risk of suicidal or violent behavior.
  4. Have been hospitalized for psychiatric disorder within 6 months before Day 1.
  5. Have a known history of neuroleptic malignant syndrome.
  6. Have a known history of long QT syndrome or cardiac arrhythmia.
  7. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed).
  8. Are currently taking tetrabenazine or deutetrabenazine, or have used valbenazine (INGREZA) within 30 days of screening.
  9. Have received an investigational drug within 30 days before Day 1 or plan to use an investigational drug (other than NBI-98854) during the study.
  10. Have a blood loss ≥550 mL or donated blood within 30 days prior to Baseline.
  11. Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors (eg, tetrabenazine, deutetrabenazine).
  12. Are currently pregnant or breastfeeding.
  13. Have HIV or hepatitis B.

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): NCT03891862


Locations
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United States, Arkansas
Neurocrine Clinical Site
Little Rock, Arkansas, United States, 72211
United States, California
Neurocrine Clinical Site
Anaheim, California, United States, 92804
Neurocrine Clinical Site
Anaheim, California, United States, 92805
Neurocrine Clinical Site
Costa Mesa, California, United States, 92627
Neurocrine Clinical Site
Escondido, California, United States, 92056
Neurocrine Clinical Site
Fountain Valley, California, United States, 92708
Neurocrine Clinical Site
Glendale, California, United States, 91206
Neurocrine Clinical Site
La Habra, California, United States, 90631
Neurocrine Clinical Site
Lemon Grove, California, United States, 91945
Neurocrine Clinical Site
Norwalk, California, United States, 90650
Neurocrine Clinical Site
San Bernardino, California, United States, 92408
Neurocrine Clinical Site
San Diego, California, United States, 92108
Neurocrine Clinical Site
Torrance, California, United States, 90502
United States, Colorado
Neurocrine Clinical Site
Pueblo, Colorado, United States, 81003
United States, Florida
Neurocrine Clinical Site
Hialeah, Florida, United States, 33012
Neurocrine Clinical Site
Hialeah, Florida, United States, 33013
Neurocrine Clinical Site
Hialeah, Florida, United States, 33018
Neurocrine Clinical Site
Miami, Florida, United States, 33183
Neurocrine Clinical Site
North Miami, Florida, United States, 33161
Neurocrine Clinical Site
Orlando, Florida, United States, 32803
United States, Indiana
Neurocrine Clinical Site
South Bend, Indiana, United States, 46601
United States, Michigan
Neurocrine Clinical Site
Bloomfield Hills, Michigan, United States, 48302
Neurocrine Clinical Site
East Lansing, Michigan, United States, 48824
Neurocrine Clinical Site
Grand Rapids, Michigan, United States, 49503
United States, Missouri
Neurocrine Clinical Site
Kansas City, Missouri, United States, 64108
Neurocrine Clinical Site
Saint Louis, Missouri, United States, 63109
United States, Nebraska
Neurocrine Clinical Site
Lincoln, Nebraska, United States, 68526
United States, Nevada
Neurocrine Clinical Site
Las Vegas, Nevada, United States, 89102
United States, New York
Neurocrine Clinical Site
New York, New York, United States, 10029
United States, Ohio
Neurocrine Clinical Site
Beachwood, Ohio, United States, 44122
Neurocrine Clinical Site
Mason, Ohio, United States, 45040
United States, Oklahoma
Neurocrine Clinical Site
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Neurocrine Clinical Site
Conshohocken, Pennsylvania, United States, 19428
Neurocrine Clinical Site
Scranton, Pennsylvania, United States, 18503
United States, Tennessee
Neurocrine Clinical Site
Franklin, Tennessee, United States, 37067
United States, Texas
Neurocrine Clinical Site
DeSoto, Texas, United States, 75115
Neurocrine Clinical Site
Houston, Texas, United States, 44030
Neurocrine Clinical Site
Houston, Texas, United States, 77058
Neurocrine Clinical Site
Irving, Texas, United States, 75062
Neurocrine Clinical Site
Richmond, Texas, United States, 77407
United States, Virginia
Neurocrine Clinical Site
Petersburg, Virginia, United States, 23805
United States, Washington
Neurocrine Clinical Site
Spokane, Washington, United States, 99202
Puerto Rico
Neurocrine Clinical Site
San Juan, Puerto Rico, 00926
Sponsors and Collaborators
Neurocrine Biosciences
Investigators
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Study Director: Chief Medical Officer Chief Medical Officer
  Study Documents (Full-Text)

Documents provided by Neurocrine Biosciences:
Study Protocol  [PDF] May 14, 2019
Statistical Analysis Plan  [PDF] August 2, 2020

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Responsible Party: Neurocrine Biosciences
ClinicalTrials.gov Identifier: NCT03891862    
Other Study ID Numbers: NBI-98854-TD4002
First Posted: March 27, 2019    Key Record Dates
Results First Posted: March 10, 2021
Last Update Posted: March 10, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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