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Open-label Extension Study of Pramipexole in the Treatment of Children and Adolescents With Tourette Syndrome

NCT00681863 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2014-05-23

Study results available
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Summary

The primary objective of this open-label, flexible dose study is to assess the safety and efficacy of pramipexole over a 24-week period in children and adolescents (age 6-17 years inclusive) diagnosed with Tourette Syndrome according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria and who have completed either Study 248.641 (NCT 00681863) or 248.644 (NCT 00558467).

Conditions

  • Tourette Syndrome

Interventions

DRUG

pramipexole 0.125 mg BID

titrated dose for those patients whose symptoms were not controlled on the 0.0625 mg BID dose

DRUG

pramipexole 0.0625 mg QD

dose down titrated for those patients unable to tolerate the 0.0625 mg BID dosing

DRUG

pramipexole 0.125 mg TID

titrated up for those patients whose symptoms were not adequately controlled on 0.125 mg BID dose

DRUG

pramipexole 0.25 mg BID

titrated for those patients whose symptoms were not adequately controlled on 0.125 mg TID dose

DRUG

pramipexole 0.0625 mg BID

0.0625 mg BID given for first 4 wks of treatment

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2009-10-31

Countries

  • United States
  • Germany

Study Locations

More Related Trials

Entities

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 NCT00681863 on ClinicalTrials.gov