NCT00004433

Randomized Study of Pergolide in Children With Tourette Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (planned)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 7 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

OBJECTIVES: I. Evaluate the presumed mechanism of action of low dose pergolide to act acutely through the dopaminergic autoreceptor or postsynaptically at D2 sites in children 7 to 17 with tourette syndrome (GTS). II. Compare tolerability and safety of pergolide in these patients to standard neuroleptic therapy via naturalist assessment after 3-6 months of treatment using matched historical controls on neuroleptics. III. Determine efficacy of pergolide for tic control in these patients.

Detailed description

PROTOCOL OUTLINE: This is a three part study: part I is a randomized, double blind, fixed single dose study; part II is a randomized, open label, stratified study; and part III is a randomized, double blind, placebo controlled study. Part I patients are randomized to receive oral pergolide at one of three dose levels or placebo for 10 weeks. Part II patients are randomized to receive either low or high dose pergolide for 4 weeks. Part III patients are randomized to first receive either pergolide or placebo by oral fixed doses twice daily followed by flexible clinically adjusted dosing for the next 3 weeks after a 2-week placebo run-in. Patients then cross over to receive the other treatment after another 2 weeks of placebo run-in. Total treatment duration is 16 weeks. Patients are followed at 6 months. Completion date provided represents the completion date of the grant per OOPD records

Conditions

• Tourette Syndrome

Interventions

Type	Name	Description
DRUG	pergolide

Timeline

• Start date: 1994-12-01
• Completion: 2002-09-01
• First posted: 1999-10-19
• Last updated: 2015-03-25