Open-label Extension Study of Pramipexole in the Treatment of Children and Adolescents With Tourette Syndrome

PHASE3TerminatedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

May 31, 2008

Primary Completion Date

October 31, 2009

Conditions
Tourette Syndrome
Interventions
DRUG

pramipexole 0.125 mg BID

titrated dose for those patients whose symptoms were not controlled on the 0.0625 mg BID dose

DRUG

pramipexole 0.0625 mg QD

dose down titrated for those patients unable to tolerate the 0.0625 mg BID dosing

DRUG

pramipexole 0.125 mg TID

titrated up for those patients whose symptoms were not adequately controlled on 0.125 mg BID dose

DRUG

pramipexole 0.25 mg BID

titrated for those patients whose symptoms were not adequately controlled on 0.125 mg TID dose

DRUG

pramipexole 0.0625 mg BID

0.0625 mg BID given for first 4 wks of treatment

Trial Locations (14)

Unknown

248.642.0026 Boehringer Ingelheim Investigational Site, Bradenton

248.642.0025 Boehringer Ingelheim Investigational Site, Tampa

248.642.0006 Boehringer Ingelheim Investigational Site, Columbus

248.642.0005 Boehringer Ingelheim Investigational Site, Cambridge

248.642.0003 Boehringer Ingelheim Investigational Site, Manhasset

248.642.0009 Boehringer Ingelheim Investigational Site, New York

248.642.0018 Boehringer Ingelheim Investigational Site, New York

248.642.0013 Boehringer Ingelheim Investigational Site, Orangeburg

248.642.0029 Boehringer Ingelheim Investigational Site, Oklahoma City

248.642.0010 Boehringer Ingelheim Investigational Site, Providence

248.642.0030 Boehringer Ingelheim Investigational Site, Memphis

248.642.0008 Boehringer Ingelheim Investigational Site, Houston

248.642.0023 Boehringer Ingelheim Investigational Site, Norfolk

248.642.49004 Boehringer Ingelheim Investigational Site, Ulm

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY

NCT00681863 - Open-label Extension Study of Pramipexole in the Treatment of Children and Adolescents With Tourette Syndrome | Biotech Hunter | Biotech Hunter