NCT01547000 is a Phase 4 clinical trial of extended-release guanfacine (Intuniv) in Tourette Disorder, sponsored by Yale University.

Who is sponsoring NCT01547000?

NCT01547000 is sponsored by Yale University.

What drugs are being tested in NCT01547000?

Interventions in NCT01547000: placebo, extended-release guanfacine (Intuniv).

What condition does NCT01547000 study?

NCT01547000 studies Tourette Disorder, Tourette Syndrome.

Is NCT01547000 still recruiting?

NCT01547000 is currently completed. Last updated 11 August 2021.

Are results published for NCT01547000?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-08-11 · How we verify

NCT01547000

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Guanfacine in Children With Tic Disorders: A Multi-site Study

Completed Phase 4 Results posted Last updated 11 August 2021

What this trial tests

Phase 4 trial testing placebo in Tourette Disorder in 34 participants. Completed in 1 December 2016.

Timeline

1 April 2012

Primary endpoint
1 December 2016

1 December 2016

Quick facts

Lead sponsor	Yale University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	34
Start date	1 April 2012
Primary completion	1 December 2016
Estimated completion	1 December 2016
Sites	3 locations across United States

Drugs / interventions tested

placebo
extended-release guanfacine (Intuniv) — full drug profile →

Conditions studied

Tourette Disorder — all drugs for Tourette Disorder →
Tourette Syndrome — all drugs for Tourette Syndrome →

Sponsor

Yale University

Who can join

Adults 6 to 17, any sex, with Tourette Disorder or Tourette Syndrome. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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 tota

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Tourette Disorder

Currently open trials in the same condition.

NCT05942716 — Serotonin Control of Impulsivity in Tourette Disorder · Phase 2 · recruiting

Other Yale University trials

Trials by the same sponsor.

NCT06900998 — Pilot Study: Effects of Nimodipine on Alcohol Drinking · Phase 2 · not yet recruiting
NCT04910984 — Developing a Chatbot to Promote HIV Testing · NA · not yet recruiting
NCT07458087 — Accuracy of the Accuro 3S · NA · not yet recruiting
NCT07398404 — A Multiple Health Behavior Change (MHBC) Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Pa · Phase 1, PHASE2 · not yet recruiting
NCT07305324 — Improving Liver Fibrosis Diagnosis in Primary Care Using FibroX AI · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01547000 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Yale University
Last refreshed: 11 August 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01547000.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing