A randomized, double-blind, placebo- controlled, flexible dose study to evaluate the effectiveness and safety of pramipexole IR (0.125 – 0.5mg/day) compared to placebo for 6 weeks in children and adol...

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Reference: EUCTR2008-004460-39

A randomized, double-blind, placebo- controlled, flexible dose study to evaluate the effectiveness and safety of pramipexole IR (0.125 – 0.5mg/day) compared to placebo for 6 weeks in children and adolescents (age 6-17 years) who are diagnosed with Tourette’s Disorder

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Extract

The primary objective of this trial is to evaluate the safety and efficacy of the non ergot dopamine agonist pramipexole for the treatment of tics in children and adolescents (age 6-17 years inclusive) diagnosed with Tourette Disorder according to DSM-IV criteria. The primary efficacy measure will be the Total Tic Score (TTS) of the YGTSS at 6 weeks.


Inclusion criteria

  • Tourette's syndrome

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