Randomized Study of Pergolide in Children With Tourette Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2000 by FDA Office of Orphan Products Development.
Recruitment status was Active, not recruiting

Sponsor:

Collaborators:

FDA Office of Orphan Products Development

Medical University of South Carolina

Information provided by:

FDA Office of Orphan Products Development

ClinicalTrials.gov Identifier:

NCT00004433

First received: October 18, 1999

Last updated: June 23, 2005

Last verified: March 2000

History of Changes

Purpose

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.

Condition	Intervention
Tourette Syndrome	Drug: pergolide

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: Tourette syndrome

MedlinePlus related topics: Child Mental Health Tourette Syndrome

Drug Information available for: Pergolide Pergolide mesylate

U.S. FDA Resources

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:	74
Study Start Date:	December 1994

Detailed 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.

Eligibility

Ages Eligible for Study:	7 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004433

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

FDA Office of Orphan Products Development

Medical University of South Carolina

Investigators

Study Chair:

Floyd R. Sallee

Medical University of South Carolina

More Information

Publications:

Griesemer DA. Pergolide in the management of Tourette syndrome. J Child Neurol. 1997 Sep;12(6):402-3. No abstract available.

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.

ClinicalTrials.gov Identifier:	NCT00004433 History of Changes
Other Study ID Numbers:	199/13395, MUSC-6130, MUSC-FDR001111
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:

Tourette syndrome
neurologic and psychiatric disorders
rare disease

Additional relevant MeSH terms:

Tourette Syndrome
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tic Disorders
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn

Mental Disorders Diagnosed in Childhood
Mental Disorders
Pergolide
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013

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