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| Sponsors and Collaborators: |
National Institute of Mental Health (NIMH) FDA Office of Orphan Products Development Medical University of South Carolina |
|---|---|
| Information provided by: | FDA Office of Orphan Products Development |
| ClinicalTrials.gov Identifier: | NCT00004433 |
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: | Treatment, Randomized |
| Estimated Enrollment: | 74 |
| Study Start Date: | December 1994 |
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 |
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 More Information
| Study ID Numbers: | 199/13395, MUSC-6130, MUSC-FDR001111 |
| Study First Received: | October 18, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00004433 |
| Health Authority: | United States: Federal Government |
|
Tourette syndrome neurologic and psychiatric disorders rare disease |
|
Ganglion Cysts Basal Ganglia Diseases Rare Diseases Central Nervous System Diseases Tourette Syndrome Tic Disorders Brain Diseases Neurodegenerative Diseases Tics |
Dopamine Heredodegenerative Disorders, Nervous System Genetic Diseases, Inborn Mental Disorders Movement Disorders Mental Disorders Diagnosed in Childhood Gilles de la Tourette's syndrome Pergolide |
|
Neurotransmitter Agents Pathologic Processes Disease Molecular Mechanisms of Pharmacological Action Syndrome |
Physiological Effects of Drugs Nervous System Diseases Dopamine Agents Dopamine Agonists Pharmacologic Actions |
