Trials / Completed
CompletedNCT00558467
Pramipexole Pilot Phase II Study in Children and Adolescents With Tourette Disorder According to DSM-IV Criteria
A Randomized, Double-blind, Placebo-controlled, Flexible Dose Study to Evaluate Efficacy and Safety of Pramipexole Immediate Release (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.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 63 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- All
- Age
- 6 Years – 17 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | pramipexole immediate release (IR) | |
| DRUG | Placebo |
Timeline
- Start date
- 2008-01-01
- Primary completion
- 2009-06-01
- First posted
- 2007-11-15
- Last updated
- 2014-05-16
- Results posted
- 2010-10-20
Locations
16 sites across 2 countries: United States, Germany
Source: ClinicalTrials.gov record NCT00558467. Inclusion in this directory is not an endorsement.