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NCT00558467 · ClinicalTrials.gov registry record · Phase 2
Pramipexole Pilot Phase II Study in Children and Adolescents With Tourette Disorder According to DSM-IV Criteria
A Phase 2 study of Tourette Syndrome, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 63
- Enrollment target
- 16
- Study locations
NCT00558467: Completed Phase 2 study of Tourette Syndrome, sponsored by Boehringer Ingelheim.
NCT00558467 is a Phase 2 study of Tourette Syndrome that has completed, run by Boehringer Ingelheim. The registered enrollment target is 63 participants, below the 85-participant average among 33 other Tourette Syndrome trials with a reported enrollment target (26% lower). The trial reports 16 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00558467, a Phase 2 study of Tourette Syndrome, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 63 participants
- Enrollment target
- 16
- Study locations
Study 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.
Primary Outcome
Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50. Analysis was adjusted for baseline total tic score and age as linear covariates.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG pramipexole immediate release (IR)
Study Locations (16)
New York
- 248.644.0003 Boehringer Ingelheim Investigational Site - Manhasset
- 248.644.0009 Boehringer Ingelheim Investigational Site - New York
- 248.644.0018 Boehringer Ingelheim Investigational Site - New York
- 248.644.0013 Boehringer Ingelheim Investigational Site - Orangeburg
Florida
- 248.644.0026 Boehringer Ingelheim Investigational Site - Bradenton
- 248.644.0025 Boehringer Ingelheim Investigational Site - Tampa
Other
- 248.644.49001 Boehringer Ingelheim Investigational Site - Hanover
- 248.644.49004 Boehringer Ingelheim Investigational Site - Ulm
Georgia
- 248.644.0006 Boehringer Ingelheim Investigational Site - Columbus
Illinois
- 248.644.0012 Boehringer Ingelheim Investigational Site - Chicago
Massachusetts
- 248.644.0005 Boehringer Ingelheim Investigational Site - Cambridge
Oklahoma
- 248.644.0029 Boehringer Ingelheim Investigational Site - Oklahoma City
Rhode Island
- 248.644.0010 Boehringer Ingelheim Investigational Site - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2008-01 |
| Phase | Phase 2 |
What the finished NCT00558467 record still lists
NCT00558467 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 85-participant average among 33 other Tourette Syndrome trials with a reported enrollment target (26% lower).
The record links to 1 condition, with Tourette Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00558467 lists 16 locations in 11 states (New York, Florida, Other).
Frequently Asked Questions
What is clinical trial NCT00558467 about?
NCT00558467 is a clinical study titled "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 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 Ya...
What is the current status of trial NCT00558467?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2008-01.
What conditions does trial NCT00558467 study?
This clinical trial studies the following conditions: Tourette Syndrome.
What interventions are being tested in trial NCT00558467?
The interventions under investigation include: Placebo (DRUG), pramipexole immediate release (IR) (DRUG).
Who is sponsoring clinical trial NCT00558467?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00558467 being conducted?
This trial has 16 study locations across Florida, Georgia, Illinois, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Tourette Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00558467's enrollment target sits among peer trials
63 14th of 33 higher than 20 of 33 other Tourette Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tourette Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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