search
Back to results

Randomized Study of Pergolide in Children With Tourette Syndrome

Primary Purpose

Tourette Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
pergolide
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tourette Syndrome focused on measuring Tourette syndrome, neurologic and psychiatric disorders, rare disease

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 18, 1999
    Last Updated
    March 24, 2015
    Sponsor
    Children's Hospital Medical Center, Cincinnati
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00004433
    Brief Title
    Randomized Study of Pergolide in Children With Tourette Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2000
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1994 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    September 2002 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Children's Hospital Medical Center, Cincinnati

    4. Oversight

    5. Study Description

    Brief 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.
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tourette Syndrome
    Keywords
    Tourette syndrome, neurologic and psychiatric disorders, rare disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Allocation
    Randomized
    Enrollment
    74 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    pergolide

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Floyd R. Sallee
    Organizational Affiliation
    Medical University of South Carolina
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    9309526
    Citation
    Griesemer DA. Pergolide in the management of Tourette syndrome. J Child Neurol. 1997 Sep;12(6):402-3. No abstract available.
    Results Reference
    background
    PubMed Identifier
    9159736
    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. doi: 10.1002/mds.870120320.
    Results Reference
    background

    Learn more about this trial

    Randomized Study of Pergolide in Children With Tourette Syndrome

    We'll reach out to this number within 24 hrs