NCT00681863

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

Open Label Extension Study With Pramipexole (PPX) in Children With Tourette Syndrome

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this open-label, flexible dose study is to assess the safety and efficacy of pramipexole over a 24-week period in children and adolescents (age 6-17 years inclusive) diagnosed with Tourette Syndrome according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria and who have completed either Study 248.641 (NCT 00681863) or 248.644 (NCT 00558467).

Conditions

• Tourette Syndrome

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-05-01
• Primary completion: 2009-10-01
• First posted: 2008-05-21
• Last updated: 2014-05-23
• Results posted: 2010-12-17

Locations

14 sites across 2 countries: United States, Germany