Phase III Randomized, Double-Blind, Placebo-Controlled Study of Guanfacine for Tourette Syndrome and Attention Deficit Hyperactivity Disorder - Full Text View

Phase III Randomized, Double-Blind, Placebo-Controlled Study of Guanfacine for Tourette Syndrome and Attention Deficit Hyperactivity Disorder

This study has been completed.

Sponsors and Collaborators:	National Center for Research Resources (NCRR) Yale University
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004376

Purpose

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
Tourette Syndrome	Drug: guanfacine	Phase III

Genetics Home Reference related topics:

familial encephalopathy with neuroserpin inclusion bodies familial paroxysmal nonkinesigenic dyskinesia Tourette syndrome

MedlinePlus related topics:

Attention Deficit Hyperactivity Disorder Tourette Syndrome

Drug Information available for:

Guanfacine Guanfacine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	35
Study Start Date:	September 1994
Estimated Study Completion Date:	June 2000

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	7 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Tourette syndrome or other chronic tic disorder meeting Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria
DSM-IV diagnosis of attention deficit hyperactivity disorder (ADHD) Clinician's Global Impression for ADHD greater than 4 Hyperactivity Index of Conners Parent or Teacher Questionnaire standard score 65 or higher (1.5 standard deviation units)

--Prior/Concurrent Therapy--

At least 2 weeks since medication for tics, ADHD, or obsessive compulsive disorder (4 weeks since neuroleptics or fluoxetine)
No failure on prior guanfacine

--Patient Characteristics--

Hepatic: No liver failure
Renal: No renal failure
Cardiovascular: No hypertension No other heart disease
Pulmonary: No pulmonary disease
Other: No Intelligence Quotient below 80 No current DSM-IV diagnosis of the following: Major depression Bipolar disorder Pervasive developmental disorder Psychotic disorder No seizure disorder No other significant medical condition No pregnant women

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004376

Sponsors and Collaborators

National Center for Research Resources (NCRR)

Yale University

Investigators


Study Chair:	Lawrence Scahill	Yale University

More Information

Study ID Numbers:	199/11979, YALESM-7588
First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004376
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

Tourette syndrome

neurologic and psychiatric disorders

rare disease

Study placed in the following topic categories:

Ganglion Cysts

Basal Ganglia Diseases

Rare Diseases

Attention Deficit and Disruptive Behavior Disorders

Central Nervous System Diseases

Tourette Syndrome

Tic Disorders

Neurodegenerative Diseases

Brain Diseases

Tics

Heredodegenerative Disorders, Nervous System

Genetic Diseases, Inborn

Attention Deficit Disorder with Hyperactivity

Guanfacine

Mental Disorders

Movement Disorders

Mental Disorders Diagnosed in Childhood

Hyperkinesis

Gilles de la Tourette's syndrome

Additional relevant MeSH terms:

Neurotransmitter Agents

Disease

Adrenergic alpha-Agonists

Adrenergic Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Nervous System Diseases

Cardiovascular Agents

Antihypertensive Agents

Pharmacologic Actions

Adrenergic Agonists

Pathologic Processes

Syndrome

Therapeutic Uses

ClinicalTrials.gov processed this record on November 30, 2008