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

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborators: Edison Pharmaceuticals Inc; Rembrandt Foundation
• Treatments: Ubiquinone

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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