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Sponsors and Collaborators: |
National Center for Research Resources (NCRR) Yale University |
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Information provided by: | Office of Rare Diseases (ORD) |
ClinicalTrials.gov Identifier: | NCT00004376 |
OBJECTIVES:
I. Evaluate the safety and efficacy of the alpha-2 adrenergic agonist guanfacine in children and adolescents with Tourette syndrome or other chronic tic disorder, and attention deficit hyperactivity disorder.
Condition | Intervention | Phase |
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Tourette Syndrome |
Drug: guanfacine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment |
Estimated Enrollment: | 35 |
Study Start Date: | September 1994 |
Estimated Study Completion Date: | June 2000 |
PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by pubertal status.
There is a 7- to 14-day washout with a placebo prior to treatment for all patients.
The first group receives oral guanfacine 3 times a day for 8 weeks. The dose is gradually increased to minimize sedation; by day 14, most patients are stabilized and the dose is then increased as clinically indicated and tolerated.
The second group receives a placebo 3 times a day for 8 weeks. Patients in either group may be treated with guanfacine for an additional 8 weeks.
Ages Eligible for Study: | 7 Years to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Prior/Concurrent Therapy--
--Patient Characteristics--
Study ID Numbers: | 199/11979, YALESM-7588 |
Study First Received: | October 18, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004376 History of Changes |
Health Authority: | United States: Federal Government |
Tourette syndrome neurologic and psychiatric disorders rare disease |
Neurotransmitter Agents Adrenergic alpha-Agonists Ganglion Cysts Adrenergic Agents Basal Ganglia Diseases Rare Diseases Attention Deficit and Disruptive Behavior Disorders Central Nervous System Diseases Tourette Syndrome Cardiovascular Agents Tic Disorders Antihypertensive Agents |
Neurodegenerative Diseases Brain Diseases Adrenergic Agonists Tics Heredodegenerative Disorders, Nervous System Genetic Diseases, Inborn Attention Deficit Disorder with Hyperactivity Guanfacine Mental Disorders Movement Disorders Mental Disorders Diagnosed in Childhood Hyperkinesis |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Physiological Effects of Drugs Basal Ganglia Diseases Neurodegenerative Diseases Brain Diseases Adrenergic Agonists Heredodegenerative Disorders, Nervous System Pathologic Processes Attention Deficit Disorder with Hyperactivity Movement Disorders Mental Disorders Guanfacine |
Syndrome Therapeutic Uses Mental Disorders Diagnosed in Childhood Disease Adrenergic alpha-Agonists Nervous System Diseases Central Nervous System Diseases Attention Deficit and Disruptive Behavior Disorders Tourette Syndrome Tic Disorders Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Genetic Diseases, Inborn |