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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00004433
Other study ID # 199/13395
Secondary ID MUSC-6130MUSC-FD
Status Completed
Phase N/A
First received October 18, 1999
Last updated March 24, 2015
Start date December 1994
Est. completion date September 2002

Study information

Verified date March 2000
Source FDA Office of Orphan Products Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 74
Est. completion date September 2002
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 7 Years to 17 Years
Eligibility 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

Study Design

Allocation: Randomized, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
pergolide


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Children's Hospital Medical Center, Cincinnati

References & Publications (2)

Griesemer DA. Pergolide in the management of Tourette syndrome. J Child Neurol. 1997 Sep;12(6):402-3. — View Citation

Lipinski JF, Sallee FR, Jackson C, Sethuraman G. Dopamine agonist treatment of Tourette disorder in children: results of an open-label trial of pergolide. Mov Disord. 1997 May;12(3):402-7. — View Citation

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