An interventional study of pergolide in Tourette Syndrome, sponsored by Children's Hospital Medical Center, Cincinnati. Completed. Open to participants aged 7 Years to 17 Years. Per ClinicalTrials.gov, last updated 2015-03-25.
Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Treatment
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.
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
225 studies on the registry are indexed under Tourette Syndrome; 36 are open to participants now.
This study's enrollment of 74 is above the median of 34 across 170 interventional studies indexed under Tourette Syndrome.
Browse Tourette Syndrome studies →Children's Hospital Medical Center, Cincinnati is the lead sponsor of 673 studies on the registry; 134 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 31 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
No study locations are listed for this record.
The record gives a start of Dec 1994 and a completion of Sep 2002. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2000. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pergolide
Children's Hospital Medical Center, Cincinnati →