Randomized Study of Pergolide in Children With Tourette Syndrome

This study has been completed.
Sponsor:
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00004433
First received: October 18, 1999
Last updated: March 24, 2015
Last verified: March 2000
  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:


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

Estimated Enrollment: 74
Study Start Date: December 1994
Estimated Study Completion Date: September 2002
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.

Completion date provided represents the completion date of the grant per OOPD records

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years   (Child)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Study Chair: Floyd R. Sallee Medical University of South Carolina
  More Information

Publications:
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: March 24, 2015
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:
Syndrome
Tourette Syndrome
Disease
Pathologic Processes
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
Neurodevelopmental Disorders
Mental Disorders
Pergolide
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2016