Randomized Study of Pergolide in Children With Tourette Syndrome
|Brief Title †||Randomized Study of Pergolide in Children With Tourette Syndrome|
|Official Title †|
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.
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 Type †||Interventional|
|Study Design †||Allocation: Randomized, Primary Purpose: Treatment|
|Primary Outcome Measure †|
|Secondary Outcome Measure †|
|Study Arms / Comparison Groups|
|* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.|
|Recruitment Status †||Drug|
|Estimated Enrollment †||74|
|Start Date †||December 1994|
|Primary Completion Date|
|Eligibility Criteria †||
PROTOCOL ENTRY CRITERIA:
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
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
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||7 Years - 17 Years|
|Accepts Healthy Volunteers||No|
|Location Countries †|
|NCT ID †||NCT00004433|
|Secondary IDs ††||MUSC-6130|
|Study Sponsor †||National Institute of Mental Health (NIMH)|
|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|
†† WHO trial registration data element that is required only if it exists.