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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

October 18, 1999
June 23, 2005
September 1994
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Complete list of historical versions of study NCT00004376 on ClinicalTrials.gov Archive Site
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Phase III Randomized, Double-Blind, Placebo-Controlled Study of Guanfacine for Tourette Syndrome and Attention Deficit Hyperactivity Disorder
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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.

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.

Interventional
Phase 3
Primary Purpose: Treatment
Tourette Syndrome
Drug: guanfacine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
June 2000
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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
Both
7 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00004376
199/11979, YALESM-7588
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National Center for Research Resources (NCRR)
Yale University
Study Chair: Lawrence Scahill Yale University
Office of Rare Diseases (ORD)
March 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP