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
sites
Houston, Texas 77058
1890
mi
from 98109
Houston, TX
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Anaheim, California 92805
980
mi
from 98109
Anaheim, CA
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Ann Arbor, Michigan 48109
1902
mi
from 98109
Ann Arbor, MI
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Bloomfield Hills, Michigan 48302
1916
mi
from 98109
Bloomfield Hills, MI
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Boca Raton, Florida 33431
?
mi
from 98109
Boca Raton, FL
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3400 Bainbridge Avenue
Bronx, New York 10467
2402
mi
from 98109
Bronx, NY
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Charleston, South Carolina 29414
?
mi
from 98109
Charleston, SC
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3401 North Central Avenue
Chicago, Illinois 60634
1725
mi
from 98109
Chicago, IL
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3410 Worth Street
Dallas, Texas 75243
1681
mi
from 98109
Dallas, TX
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Durham, North Carolina 27707
2341
mi
from 98109
Durham, NC
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Everett, Washington 98201
24
mi
from 98109
Everett, WA
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Gulf Breeze, Florida 32561
2206
mi
from 98109
Gulf Breeze, FL
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Hialeah, Florida 33012
2724
mi
from 98109
Hialeah, FL
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200 Hawkins Drive
Iowa City, Iowa 52242
1557
mi
from 98109
Iowa City, IA
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Leawood, Kansas 66206
1506
mi
from 98109
Leawood, KS
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Lincoln, Nebraska 68526
1346
mi
from 98109
Lincoln, NE
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Mason, Ohio 45040
1967
mi
from 98109
Mason, OH
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176 Howard Boulevard
Mount Arlington, New Jersey 07856
2366
mi
from 98109
Mount Arlington, NJ
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Naperville, Illinois 60563
1711
mi
from 98109
Naperville, IL
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Nashua, New Hampshire 03060
2454
mi
from 98109
Nashua, NH
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1 Howe Street
New Haven, Connecticut 06519
2432
mi
from 98109
New Haven, CT
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New York, New York 10036
2403
mi
from 98109
New York, NY
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Oklahoma City, Oklahoma 73112
1523
mi
from 98109
Oklahoma City, OK
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Orlando, Florida 32803
2547
mi
from 98109
Orlando, FL
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Saint Louis, Missouri 63128
1721
mi
from 98109
Saint Louis, MO
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701 6th Street South
Saint Petersburg, Florida 33701
2527
mi
from 98109
Saint Petersburg, FL
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8042 Wurzbach Road
San Antonio, Texas 78229
1779
mi
from 98109
San Antonio, TX
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San Diego, California 92108
1065
mi
from 98109
San Diego, CA
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San Juan, 00926
3730
mi
from 98109
San Juan,
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Santa Ana, California 92705
926
mi
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Santa Ana, CA
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21311 Alder Drive
Santa Clarita, California 91321
937
mi
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Santa Clarita, CA
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10515 West Santa Fe Drive
Sun City, Arizona 85351
1101
mi
from 98109
Sun City, AZ
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Tacoma, Washington 98405
?
mi
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Tacoma, WA
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Tampa, Florida 33609
2527
mi
from 98109
Tampa, FL
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Voorhees, New Jersey 08043
2386
mi
from 98109
Voorhees, NJ
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