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

This study has been completed.
Sponsor:
Collaborator:
Yale University
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004376
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: March 2001
History of Changes
  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 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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

No publications provided

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

Keywords provided by Office of Rare Diseases (ORD):
Tourette syndrome
neurologic and psychiatric disorders
rare disease

Additional relevant MeSH terms:
Tourette Syndrome
Attention Deficit Disorder with Hyperactivity
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
Mental Disorders Diagnosed in Childhood
Mental Disorders
 Attention Deficit and Disruptive Behavior Disorders
Guanfacine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013