Randomized Study of Pergolide in Children With Tourette Syndrome

Study Overview
=================
Brief 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

Intervention / Treatment
-----------------
* Drug: pergolide


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- DSM IV primary diagnosis of Tourette syndrome (GTS) Multiple Axis I and Axis II diagnoses allowed Tourette symptom severity great enough to warrant medication (CGI severity index at least 4) No chronic motor tic disorder or transient tic disorder, anorexia nervosa, pervasive developmental disorders, substance/alcohol abuse or dependence within the past year, schizophrenia or any psychotic disorder --Prior/Concurrent Therapy-- At least 4 weeks since prior neuroleptic therapy At least 2 weeks since all other prior medications No concurrent neuroleptic therapy or psychotropic therapy (i.e., antidepressant or anticholinergic) No concurrent medication that may alter or interact with pergolide --Patient Characteristics-- Performance status: Outpatient status Hematopoietic: Normal or clinically insignificant values Hepatic: Normal or clinically insignificant values Renal: Normal or clinically insignificant values Cardiovascular: Normal electrocardiogram Other: No serious or unstable medical illness (i.e., diabetes, seizure disorder); Must be able to perform required measurements (i.e., no low I.Q.); Effective contraception required by all fertile patients

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: pergolide|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tourette syndrome, neurologic and psychiatric disorders, rare disease