Open Label Trial of Aripiprazole in Children and Adolescents With Tourette's Disorder

PHASE4CompletedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

September 30, 2005

Primary Completion Date

August 31, 2008

Study Completion Date

February 28, 2010

Conditions
Tourette's SyndromeTic Disorders
Interventions
DRUG

Aripiprazole

Baseline Visit 2: Subjects btw 25-50kg start on 1.25mg/day, btw 50-70kg start on 2.5mg/day, greater than 70kg start on 5mg/day Visit 3: Titrated based on YGTSS \& CGI-TS ratings at investigator discretion. Subjects who show evidence of response (reduction in CGI-TS by 1-2 points) may remain on same dose. Subjects who show no response may increase as follows: btw 25-50kg increase to 2.5mg/day, btw 50-70kg increase to 3.75mg/day, greater than 70kg increase to 7.5mg/day Visit 5: Subjects who show no response may increase as follows: btw 25-50kg increase to 3.75mg/day, btw 50-70kg increase to 5mg/day, greater than 70kg increase to 10mg/day Visit 6: Subjects who show no response may be increase as follows: btw 25-50kg increase to 5mg/day, btw 50-70kg increase to 7.5mg/day, greater than 70kg increase to 12.5mg/day Visit 7: Subjects who how no response may be increase as follows: btw 25-50kg increase to 7.5mg/day, btw 50-70kg increase to 10mg/day, greater than 70kg increase to 15mg/day

Trial Locations (1)

10016

NYU Child Study Center, New York

All Listed Sponsors
lead

NYU Langone Health

OTHER

NCT00241176 - Open Label Trial of Aripiprazole in Children and Adolescents With Tourette's Disorder | Biotech Hunter | Biotech Hunter