Guanfacine in Children With Tic Disorders

• ClinicalTrials.gov Identifier: NCT01547000
• Recruitment Status: Completed
• First Posted: March 7, 2012
• Results First Posted: June 8, 2018
• Last Update Posted: June 8, 2018
• Sponsor: Yale University
• Collaborators: Icahn School of Medicine at Mount Sinai; University of South Florida; Shire; New York University
• Information provided by (Responsible Party): Yale University

Tracking Information

• First Submitted Date: March 1, 2012
• First Posted Date: March 7, 2012
• Results First Submitted Date: January 15, 2018
• Results First Posted Date: June 8, 2018
• Last Update Posted Date: June 8, 2018
• Study Start Date: April 2012
• Actual Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 8, 2018)

Yale Global Tic Severity Scale (YGTSS) [ Time Frame: 8 weeks ]

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.

• Original Primary Outcome Measures (submitted: March 6, 2012): Yale Global Tic Severity Scale [ Time Frame: 8 weeks ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Guanfacine in Children With Tic Disorders
• Official Title: Guanfacine in Children With Tic Disorders: A Multi-site Study
• 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).

Detailed Description

Guanfacine is commonly used for the treatment of tics in children with Tourette Disorder, but neither the immediate release compound nor the new extended release formulation have been evaluated for tics as a primary outcome. This pilot study is not designed to demonstrate efficacy of extended release guanfacine in the treatment of tics in children with TD. Rather, the goal of this trial is to determine whether extended release guanfacine warrants further study in a large scale trial. Immediate-release guanfacine is frequently used in children with TD, but dosing, time to effect and adverse effects with the new extended release guanfacine are unknown. The use of placebo in this trial reduces bias in the measurement of outcomes because it ensures blindness in the parent and clinician ratings.

This is a three-site, investigator-initiated, randomized, double-blind, placebo-controlled, parallel-group study. Subjects who show a positive response to extended release guanfacine in the 8-week double-blind phase will continue on the the drug in an 8-week extension phase. Subjects who are randomly assigned to placebo and do not show improvement will be offered 8-weeks of open-label treatment with Intuniv.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Tourette Disorder
• Tourette Syndrome

Intervention

• Drug: placebo
  Administered up to 8 weeks.
• Drug: extended-release guanfacine (Intuniv)
  1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks.
  Other Name: Intuniv

Study Arms

• Placebo Comparator: Inactive placebo
  Intervention: Drug: placebo
• Experimental: Extended-release Guanfacine
  Intervention: Drug: extended-release guanfacine (Intuniv)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 23, 2017): 34
• Original Estimated Enrollment (submitted: March 6, 2012): 42
• Actual Study Completion Date: December 2016
• Actual Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Years to 17 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01547000
• Other Study ID Numbers: 1004006635
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Yale University
• Study Sponsor: Yale University

Collaborators

• Icahn School of Medicine at Mount Sinai
• University of South Florida
• Shire
• New York University

Investigators

• Study Director: Lawrence D Scahill, MSN, PhD; Emory University
• Principal Investigator: 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

• PRS Account: Yale University
• Verification Date: February 2018