The Potential for Clinical Dependence and Withdrawal Symptoms Associated With Valbenazine



Status:Recruiting
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 65
Updated:11/8/2018
Start Date:September 14, 2018
End Date:April 2019
Contact:Cheryl Chen
Email:cechen@neurocrine.com
Phone:858-617-7744

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A Phase 4, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Potential for Clinical Dependence and Withdrawal Symptoms Associated With Valbenazine

This is a Phase 4, randomized, double-blind, placebo-controlled study to evaluate the
potential for clinical dependence and withdrawal symptoms associated with valbenazine.


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 a known history of neuroleptic malignant syndrome.

5. Have a known history of long QT syndrome or cardiac arrhythmia.

6. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed).

7. Have ever taken valbenazine (INGREZZA or NBI-98854) or participated in a valbenazine
clinical study.

8. Have received an investigational drug within 30 days before screening or plan to use
an investigational drug (other than NBI-98854) during the study.

9. Have a blood loss ≥550 mL or donated blood within 30 days prior to Baseline.

10. Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors (eg,
tetrabenazine, deutetrabenazine).

11. Are currently pregnant or breastfeeding.

12. Have HIV or hepatitis B.
We found this trial at
14
sites
Oceanside, California 92056
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Anaheim, California 92805
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Ann Arbor, Michigan 48109
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Ann Arbor, MI
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Beechwood, Ohio 44122
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DeSoto, Texas 75115
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DeSoto, TX
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Glendale, California 91206
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Glendale, CA
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Hialeah, Florida 33012
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Hialeah, FL
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Honolulu, Hawaii 96817
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Honolulu, HI
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Irving, Texas 75062
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Irving, TX
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Norwalk, California 90650
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Norwalk, CA
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Oklahoma City, Oklahoma 73112
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Oklahoma City, OK
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San Bernardino, California 92108
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San Bernardino, CA
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San Juan, 00926
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San Juan,
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Scranton, Pennsylvania 18503
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Scranton, PA
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