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

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

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.

Phase 3
Interventional
Primary Purpose: Treatment
  • Tourette Syndrome
Drugguanfacine
    * Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
    Drug
    35
    September 1994
    June 2000

    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 - 16 Years
    No
    • , ,
    • , ,
    NCT00004376
    199/11979
    YALESM-7588
    ,
    National Center for Research Resources (NCRR)
    • Yale University
    Study Chair: Lawrence Scahill, Yale University
    Office of Rare Diseases (ORD)
    March 2001
    October 18, 1999
    June 23, 2005
    Required WHO trial registration data element.
    †† WHO trial registration data element that is required only if it exists.