Randomized Study of Pergolide in Children With Tourette Syndrome

NCT00004433 | Completed

• 3 other identifiers: 199/13395MUSC-6130MUSC-FDR001111
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tourette Syndrome

Keywords

Tourette syndrome; neurologic and psychiatric disorders; rare disease

Interventions

pergolide DRUG

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Related Publications (2)

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

  PMID: 9309526 BACKGROUND

• 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.

  PMID: 9159736 BACKGROUND

MeSH Terms

Conditions

Tourette Syndrome; Neurologic Manifestations; Mental Disorders; Rare Diseases

Interventions

Pergolide

Condition Hierarchy (Ancestors)

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; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Officials

• Floyd R. Sallee

  Medical University of South Carolina

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 18, 1999
• First Posted: October 19, 1999
• Study Start: December 1, 1994
• Study Completion: September 1, 2002
• Last Updated: March 25, 2015

Record last verified: 2000-03