NCT01547000

Brief Summary

The goal of this pilot study is to obtain preliminary information on the tolerability and efficacy of extended release guanfacine (trade name Intuniv) in children with Tourette Disorder (TD, also called Tourette syndrome).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2012

Longer than P75 for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2012

Completed
25 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

June 8, 2018

Completed
Last Updated

August 13, 2021

Status Verified

August 1, 2021

Enrollment Period

4.7 years

First QC Date

March 1, 2012

Results QC Date

January 15, 2018

Last Update Submit

August 11, 2021

Conditions

Tourette DisorderTourette Syndrome

Keywords

Tourette SyndromeTourette DisorderTicsMotor ticsVocal ticsIntunivGuanfacineMedicationDrugPlaceboChildChildrenAdolescent

Outcome Measures

Primary Outcomes (1)

  • Yale Global Tic Severity Scale (YGTSS)

    The YGTSS is a clinician-rated scale that begins with a systematic inquiry of tic symptoms in the preceding week. Current motor and phonic tics are rated separately according to number, frequency, intensity, complexity, and interference, each rated on 0 to 5 scale with higher scores indicating greater severity/worse outcome (Leckman et al. 1989). The YGTSS yields a total motor score (0-25), a total phonic score (0-25), a total tic score (sum of total motor and total phonic scores; 0-50), and an impairment score (0-50). Higher scores indicate greater severity/worse outcome.

    8 weeks

Study Arms (2)

Inactive placebo

PLACEBO COMPARATOR
Drug: placebo

Extended-release Guanfacine

EXPERIMENTAL
Drug: extended-release guanfacine (Intuniv)

Interventions

placeboDRUG

Administered up to 8 weeks.

Inactive placebo
extended-release guanfacine (Intuniv)DRUG

1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks.

Also known as: Intuniv
Extended-release Guanfacine

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of Tourette Disorder or chronic motor or vocal tic disorder.
  • Between ages 6 yrs 0 mos and 17 years 0 months.
  • Weight \>/= 15 kg (33 lbs).
  • Ability to swallow pills whole.

You may not qualify if:

  • IQ \< 80.
  • Positive pregnancy test.
  • Positive drug test.
  • Low blood pressure.
  • Prior history of hypersensitivity to guanfacine.
  • Prior failed treatment with an adequate trial of guanfacine in last 2 years.
  • Concurrent treatment with another psychoactive medication for tics, stimulant medication, or Habit Reversal therapy.
  • Medication for OCD, anxiety or depression will be allowed if dose is stable for 8 wks with no planned changes; SSRIs are allowed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Yale Child Study Center

New Haven, Connecticut, 06510, United States

Location

University of South Florida

Tampa, Florida, 33612, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Tourette SyndromeTics

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 DisordersMental DisordersDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsPhenylacetatesAcids, CarbocyclicCarboxylic Acids

Limitations and Caveats

We are limited by the small size of this subgroup to determine whether children with comorbid CTD and ADHD might have a significant response to extended-release guanfacine, both with regard to tics and ADHD symptoms.

Results Point of Contact

Title
Tanya K. Murphy, MD, MS
Organization
University of South Florida
tmurphy@health.usf.edu
813-974-2201

Study Officials

  • Lawrence D Scahill, MSN, PhD

    Emory University

    STUDY DIRECTOR

  • Barbara J Coffey, MD, MS

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

  • Tanya Murphy, MD, MS

    University of South Florida

    PRINCIPAL INVESTIGATOR

  • Thomas Fernandez, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2012

First Posted

March 7, 2012

Study Start

April 1, 2012

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

August 13, 2021

Results First Posted

June 8, 2018

Record last verified: 2021-08

Locations

US(3)