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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00004376

Enrollment

Registered

1999-10-19

Start date

1994-09-30

Completion date

2000-06-30

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tourette Syndrome

Keywords

Tourette syndrome, neurologic and psychiatric disorders, rare disease

Brief summary

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.

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.

Interventions

DRUGguanfacine

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

7 Years to 16 Years

Healthy volunteers

Inclusion 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026