Phase 4
Completed N=34
Guanfacine in Children With Tic Disorders
Tourette Disorder · Tourette Syndrome
Source: ClinicalTrials.gov NCT01547000 ↗
Enrolled (actual)
34
Serious AEs
2.9%
Results posted
Jun 2018
Primary outcomePrimary: Yale Global Tic Severity Scale (YGTSS) — 24.72; 23.56; 15.00; 12.94 units on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Yale Global Tic Severity Scale (YGTSS) |
24.72; 23.56; 15.00; 12.94; 9.72; 10.63 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01547000). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.