Randomized Study of Pergolide in Children With Tourette Syndrome

Randomized Study of Pergolide in Children With Tourette Syndrome

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.

N/A
Interventional
Allocation: Randomized, Primary Purpose: Treatment
  • Tourette Syndrome
Drugpergolide
    * Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
    Drug
    74
    December 1994

    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

    Both
    7 Years - 17 Years
    No
    • , ,
    • , ,
    NCT00004433
    199/13395
    MUSC-6130
    ,
    National Institute of Mental Health (NIMH)
    • FDA Office of Orphan Products Development
    • Medical University of South Carolina
    Study Chair: Floyd R. Sallee, Medical University of South Carolina
    FDA Office of Orphan Products Development
    March 2000
    October 18, 1999
    June 23, 2005
    Required WHO trial registration data element.
    †† WHO trial registration data element that is required only if it exists.