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| Descriptive Information Fields | |||||
| Brief Title † | Pramipexole Pilot Phase II Study in Children and Adolescents With Tourette Disorder According to DSM-IV Criteria | ||||
| Official Title † | A Randomized, Double-Blind, Placebo-Controlled, Flexible Dose Study to Evaluate Efficacy and Safety of Pramipexole IR (0.125-0.5mg/Day) Versus Placebo for 6 Weeks in Children and Adolescents (Age 6-17 Inclusive) Diagnosed With Tourette Disorder According to DSM IV Criteria. | ||||
| Brief Summary | A randomized, double-blind, placebo-controlled, flexible dose study to evaluate efficacy and safety of Pramipexole versus placebo for 6 weeks in children (age 6-17) diagnosed with Tourette Disorder according to DSM IV criteria. The primary efficacy measure will be the Total Tic Score (TTS) of the Yale Global Tic Severity Scale (YGTSS) at 6 weeks. |
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| Detailed Description | |||||
| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Parallel Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | Mean change from baseline of the TTS of the YGTSS after 6 weeks of treatment [ Time Frame: 6 weeks ] | ||||
| Secondary Outcome Measure † | YGTSS [ Time Frame: 6 weeks ] | ||||
| Condition † | Tourette Syndrome | ||||
| Intervention † | Drug: pramipexole IR | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 54 | ||||
| Start Date † | January 2008 | ||||
| Completion Date | |||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 6 Years to 17 Years | ||||
| Accepts Healthy Volunteers | |||||
| Contacts †† |
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| Location Countries † | United States, Germany | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00558467 | ||||
| Organization ID | 248.644 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Boehringer Ingelheim Pharmaceuticals | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Boehringer Ingelheim Pharmaceuticals | ||||
| Verification Date | November 2008 | ||||
| First Received Date † | November 14, 2007 | ||||
| Last Updated Date | November 20, 2008 | ||||