Randomized Study of Pergolide in Children With Tourette Syndrome

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Tourette Syndrome

Treatments: Drug: pergolide

Study type: Interventional

Funder types: Other

Identifiers

NCT00004433

199/13395

MUSC-6130

MUSC-FDR001111

Details and patient eligibility

About

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.

Full 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

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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