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Pramipexole Pilot Phase II Study in Children and Adolescents With Tourette Disorder According to DSM-IV Criteria

NCT00558467 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2014-05-16

Study results available
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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

  • Tourette Syndrome

Interventions

DRUG

pramipexole immediate release (IR)

DRUG

Placebo

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2009-06-30

Countries

  • United States
  • Germany

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00558467 on ClinicalTrials.gov