NCT00004376

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 1994

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1994

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

October 18, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 1999

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2000

Completed
Last Updated

June 24, 2005

Status Verified

March 1, 2001

First QC Date

October 18, 1999

Last Update Submit

June 23, 2005

Conditions

Tourette Syndrome

Keywords

Tourette syndromeneurologic and psychiatric disordersrare disease

Interventions

guanfacineDRUG

Eligibility Criteria

Age7 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
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

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Sponsors & Collaborators

MeSH Terms

Conditions

Tourette SyndromeNeurologic ManifestationsMental DisordersRare Diseases

Interventions

Guanfacine

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTic DisordersMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeurodevelopmental DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsPhenylacetatesAcids, CarbocyclicCarboxylic Acids

Study Officials

  • Lawrence Scahill

    Yale University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

October 18, 1999

First Posted

October 19, 1999

Study Start

September 1, 1994

Study Completion

June 1, 2000

Last Updated

June 24, 2005

Record last verified: 2001-03