Open-Trial of EPI-743 for Adults With Tourette Syndrome

Completed · Phase 1

Conditions studied: Tourette Syndrome

In brief

The purpose of this study is to examine the effects of EPI-743 on tic severity in adults with Tourette syndrome.

Key facts

Study ID: NCT01719523
Run by: Yale University
People needed: 10
Starts: 2012-10-01
Expected to finish: 2013-10-01
Last updated by the study team: 2014-03-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Adult between 18-65 years of age
Meet DSM IV criteria for the diagnosis of Tourette's syndrome
Significant current tic symptoms: YGTSS total tic score greater than or equal to 22 at baseline
On stable psychiatric medication regimen for a minimum of 4 weeks prior to beginning the trial.
Accepted method of birth control
Willingness to participate in an HMPAO SPECT scan at baseline and after 4 weeks of treatment.

You may not qualify if…

Comorbid bipolar disorder, psychotic disorder, substance use disorder, developmental disorder or intellectual disability (IQ<70).
Recent change (less than 4 weeks) in medications that have potential effects on tic severity. Medication change is defined to include dose changes or medication discontinuation.
Recent change in behavioral treatment for Tourette syndrome or comorbid conditions (i.e. OCD) within the last 4 weeks or initiation of behavioral therapy for tics within the last 12 weeks.
Known hypersensitivity or previous anaphylactoid reaction to EPI-743 or any components in its preparation
Positive pregnancy test or drug screening test
Clinical history of bleeding disorder or abnormal baseline PT/PTT
Hepatic insufficiency with LFTs greater than two times upper limit of normal

Where it is running

Yale Child Study Center — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.