Open-Label Safety and Tolerability Study of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome



Status:Enrolling by invitation
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:6 - 18
Updated:3/15/2019
Start Date:February 8, 2018
End Date:June 2019

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Open-Label Safety and Tolerability Study of Optimized Doses of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome

This is a Phase 2b, multicenter, open-label study to evaluate the safety and tolerability of
optimized doses of NBI-98854 administered once daily for 24 weeks in pediatric subjects with
Tourette Syndrome.


Inclusion Criteria:

1. Have participated in and completed Study NBI-98854-TS2003

2. Have a clinical diagnosis of Tourette Syndrome (TS)

3. If using maintenance medication(s) for TS or TS spectrum diagnoses (e.g.
obsessive-compulsive disorder [OCD], Attention-Deficit Hyperactivity Disorder [ADHD]),
be on stable doses

4. Be in good general health

5. Adolescent subjects (12 to 18 years of age) must have a negative urine drug screen for
amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or
cannabinoids and a negative alcohol screen

6. Subjects of childbearing potential who do not practice total abstinence 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

Exclusion Criteria:

1. Have an active, clinically significant unstable medical condition within 1 month prior
to screening

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

3. Have a known history of neuroleptic malignant syndrome

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

5. Have an allergy, hypersensitivity, or intolerance to vesicular monoamine transporter 2
(VMAT2) inhibitors

6. Have a blood loss ≥250 mL or donated blood within 56 days prior to screening

7. Have a known history of substance (drug) dependence, or substance or alcohol abuse

8. Have a significant risk of suicidal or violent behavior

9. Have received an investigational drug within 30 days before screening or plan to use
an investigational drug (other than NBI-98854) during the study
We found this trial at
35
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Saint Louis, Missouri 63128
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Anaheim, California 92805
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Ann Arbor, Michigan 48109
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Bloomfield Hills, Michigan 48302
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Boca Raton, Florida 33431
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3400 Bainbridge Avenue
Bronx, New York 10467
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Charleston, South Carolina 29414
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Charleston, SC
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3401 North Central Avenue
Chicago, Illinois 60634
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Chicago, IL
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3410 Worth Street
Dallas, Texas 75243
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Durham, North Carolina 27707
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Everett, Washington 98201
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Gulf Breeze, Florida 32561
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Hialeah, Florida 33012
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Houston, Texas 77058
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200 Hawkins Drive
Iowa City, Iowa 52242
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Iowa City, IA
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Leawood, Kansas 66206
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Lincoln, Nebraska 68526
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Lincoln, NE
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Mason, Ohio 45040
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176 Howard Boulevard
Mount Arlington, New Jersey 07856
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Naperville, Illinois 60563
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Nashua, New Hampshire 03060
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1 Howe Street
New Haven, Connecticut 06519
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New York, New York 10036
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Oklahoma City, Oklahoma 73112
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Orlando, Florida 32803
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701 6th Street South
Saint Petersburg, Florida 33701
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8042 Wurzbach Road
San Antonio, Texas 78229
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San Diego, California 92108
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San Juan, 00926
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Santa Ana, California 92705
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21311 Alder Drive
Santa Clarita, California 91321
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10515 West Santa Fe Drive
Sun City, Arizona 85351
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Tacoma, Washington 98405
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Tampa, Florida 33609
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Voorhees, New Jersey 08043
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