An open-label, flexible dose, follow-up study to evaluate safety and efficacy of oral pramipexole (0.0625-0.5 mg/day) for 24 weeks in children and adolescents (age 6-17 years) diagnosed with Tourette Syndrome according to DSM-IV criteria and who have completed the double-blind phase of either study 248.641 or 248.644

Registry ID
EUCTR2008-000342-32
Source registry
EUCTR
Status
Prematurely Ended
Phase
PHASE3
Sponsor
Boehringer Ingelheim Pharma GmbH & Co. KG
Start date
2009-01-02
Completion date
2009-08-14
Last update
2026-08-16

Conditions

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 DSM-IV criteria and who have completed either Study 248.641 or 248.644. The safety of pramipexole will be evaluated collectively for the incidence of adverse events, the proportion of withdrawals due to drug related adverse events, and the assessment of the following scales: • Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS); • Child Behavior Checklist (CBCL) ; • DuPaul Attention-Deficit / Hyperactivity Disorder (ADHD) Rating Scale-IV; • Child Depression Inventory-Short Version CDI-S; • Multidimensional Anxiety Scale for Children (MASC).

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