drugset / Trial / NCT00681863

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

NCT00681863

Phase 3 Terminated 45 enrolled Boehringer Ingelheim
Non-randomizedSingle-groupOpen-labelTreatment

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).

Timeline

Start
2008-05
Primary completion
2009-10
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator Pramipexole Unknown 0.0625 mg
Comparator Pramipexole Unknown 0.125 mg
Comparator Pramipexole Unknown 0.25 mg

Indications