Randomized Study of Pergolide in Children With Tourette Syndrome

Descriptive Information
Brief Title ^†	Randomized Study of Pergolide in Children With Tourette Syndrome
Official Title ^†
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.
Study Phase	N/A
Study Type ^†	Interventional
Study Design ^†	Allocation: Randomized, Primary Purpose: Treatment
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Tourette Syndrome
Intervention ^†	Drugpergolide
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status ^†	Drug
Estimated Enrollment ^†	74
Start Date ^†	December 1994
Completion Date
Primary Completion Date
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
Gender	Both
Ages	7 Years - 17 Years
Accepts Healthy Volunteers	No
Contacts ^††	, , , ,
Location Countries ^†
Administrative Information
NCT ID ^†	NCT00004433
Organization ID	199/13395
Secondary IDs ^††	MUSC-6130
Responsible Party	,
Study Sponsor ^†	National Institute of Mental Health (NIMH)
Collaborators ^††	FDA Office of Orphan Products Development Medical University of South Carolina
Investigators ^†	Study Chair: Floyd R. Sallee, Medical University of South Carolina
Information Provided By	FDA Office of Orphan Products Development
Verification Date	March 2000
First Received Date ^†	October 18, 1999
Last Updated Date	June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.