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



Status:Recruiting
Healthy:No
Age Range:18 - 85
Updated:3/29/2019
Start Date:March 5, 2019
End Date:October 2020
Contact:Cheryl Chen
Email:cechen@neurocrine.com
Phone:858-617-7744

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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

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


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.
We found this trial at
31
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Grand Rapids, Michigan 49503
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Anaheim, California 92805
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Beachwood, Ohio 44122
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Bloomfield Hills, Michigan 48302
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Conshohocken, Pennsylvania 19428
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Costa Mesa, California 92627
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DeSoto, Texas 75115
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Escondido, California 92056
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Franklin, Tennessee 37067
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Glendale, California 91206
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Houston, Texas 77058
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Irving, Texas 75062
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Kansas City, Missouri 64108
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La Habra, California 90631
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Lemon Grove, California 91945
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Lincoln, Nebraska 68526
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Little Rock, Arkansas 72211
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Mason, Ohio 45040
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Miami, Florida 33173
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Norwalk, California 90650
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Oklahoma City, Oklahoma 73112
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Orlando, Florida 32803
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Petersburg, Virginia 23805
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San Bernardino, California 92108
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Torrance, California 90502
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