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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 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.

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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.

Conditions Studied

Tourette Syndrome

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

FieldValue
Enrollment Target 63 participants
Start Date 2008-01
Phase Phase 2

Sponsor

Boehringer Ingelheim

515 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00558467

The ClinicalTrials.gov registry entry for NCT00558467 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 85-participant average among 33 other Tourette Syndrome trials with a reported enrollment target (26% lower). The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.

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 reports 16 study locations spanning 11 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.