Safety & Tolerability Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:7 - 18
Updated:1/1/2014
Start Date:August 2011
End Date:July 2015
Contact:CenterWatch
Email:tourettes@centerwatch.com

Use our guide to learn which trials are right for you!

An Open-Label, Multicenter Study Evaluating the Safety and Tolerability of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

The goal of the current trial is to obtain long term efficacy, safety and tolerability data
of Once weekly aripiprazole in children and adolescents with Tourette's Disorder.


Inclusion Criteria:

- Completed participation or discontinued due to lack of efficacy at week 5 or later in
either Trial 31-10-272 or 31-10-273

- Written ICF obtained from a legally acceptable representative & informed assent at
Baseline as applicable by trial center's IRB/IEC

- The subject, designated guardian(s) or caregiver(s) are able to comprehend and
satisfactorily comply with the protocol requirements, as evaluated by the
investigator.

Exclusion Criteria:

- The subject experienced AEs during the double-blind trial (31-10-272 or 31-10-273)
that would, in the investigator's judgment, preclude further exposure to
aripiprazole.

- The subject had protocol violations during the double-blind trial considered major in
the judgment of the investigator which would deem the subject a poor candidate for
the trial

- A positive drug screen at baseline for cocaine, alcohol or other drugs of abuse which
will result in early termination at Week 1

- Sexually active patients not using 2 approved methods of contraception; breastfeeding
or pregnant.

- Risk of committing suicide

- Body weight lower than 16 kg

- Abnormal laboratory test results, vital signs and ECG results
We found this trial at
42
sites
2039
mi
from 43215
Sacramento, CA
Click here to add this to my saved trials
436
mi
from 43215
Atlanta, GA
Click here to add this to my saved trials
436
mi
from 43215
Atlanta, GA
Click here to add this to my saved trials
119
mi
from 43215
Avon Lake, OH
Click here to add this to my saved trials
Bloomfield Hills, Michigan 48302
181
mi
from 43215
Bloomfield Hills, MI
Click here to add this to my saved trials
2001
mi
from 43215
Bothell, WA
Click here to add this to my saved trials
278
mi
from 43215
Charlottesville, VA
Click here to add this to my saved trials
274
mi
from 43215
Chicago, IL
Click here to add this to my saved trials
98
mi
from 43215
Cincinnati, OH
Click here to add this to my saved trials
127
mi
from 43215
Cleveland, OH
Click here to add this to my saved trials
910
mi
from 43215
Dallas, TX
Click here to add this to my saved trials
163
mi
from 43215
Detroit, MI
Click here to add this to my saved trials
618
mi
from 43215
Dothan, AL
Click here to add this to my saved trials
711
mi
from 43215
Gainesville, FL
Click here to add this to my saved trials
989
mi
from 43215
Hialeah, FL
Click here to add this to my saved trials
166
mi
from 43215
Indianapolis, IN
Click here to add this to my saved trials
499
mi
from 43215
La Crosse, WI
Click here to add this to my saved trials
622
mi
from 43215
Little Rock, AR
Click here to add this to my saved trials
1972
mi
from 43215
Los Angeles, CA
Click here to add this to my saved trials
493
mi
from 43215
Manhasset, NY
Click here to add this to my saved trials
993
mi
from 43215
Miami, FL
Click here to add this to my saved trials
993
mi
from 43215
Miami, FL
Click here to add this to my saved trials
116
mi
from 43215
Middleburg Heights, OH
Click here to add this to my saved trials
798
mi
from 43215
New Orleans, LA
Click here to add this to my saved trials
481
mi
from 43215
New York, NY
Click here to add this to my saved trials
422
mi
from 43215
Norfolk, VA
Click here to add this to my saved trials
849
mi
from 43215
Oklahoma City, OK
Click here to add this to my saved trials
682
mi
from 43215
Omaha, NE
Click here to add this to my saved trials
767
mi
from 43215
Orange City, FL
Click here to add this to my saved trials
482
mi
from 43215
Orangeburg, NY
Click here to add this to my saved trials
624
mi
from 43215
Overland Park, KS
Click here to add this to my saved trials
416
mi
from 43215
Philadelphia, PA
Click here to add this to my saved trials
2039
mi
from 43215
Sacramento, CA
Click here to add this to my saved trials
1513
mi
from 43215
Salt Lake City, UT
Click here to add this to my saved trials
1144
mi
from 43215
San Antonio, TX
Click here to add this to my saved trials
1144
mi
from 43215
San Antonio, TX
Click here to add this to my saved trials
1951
mi
from 43215
San Diego, CA
Click here to add this to my saved trials
2107
mi
from 43215
San Francisco, CA
Click here to add this to my saved trials
1960
mi
from 43215
Santa Ana, CA
Click here to add this to my saved trials
842
mi
from 43215
St. Petersburg, FL
Click here to add this to my saved trials
472
mi
from 43215
Staten Island, NY
Click here to add this to my saved trials
1932
mi
from 43215
Wildomar, CA
Click here to add this to my saved trials