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

NCT01719523 | Completed Phase 1

• 1 other identifier: 120100953972412
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tourette Syndrome

Keywords

Tourette syndrome; Tics; Tic Disorders

Outcome Measures

Primary Outcomes (3)

• Yale Global Tic Severity Scale

  Baseline

• Yale Global Tic Severity Scale

  2 weeks

• Yale Global Tic Severity Scale

  4 weeks

Secondary Outcomes (19)

• Premonitory Urge for Tics Scale

  Baseline

• Yale-Brown Obsessive Compulsive Scale

  Baseline

• Connors Adult Attention Deficit Hyperactivity Rating Scale

  Baseline

• Hamilton Rating Scales for Depression and Anxiety

  Baseline

• Clinical Global Improvement

  Week 4

Other Outcomes (2)

• HMPAO Uptake in Frontal-Striatal Circuit on SPECT Scan

  Baseline

• HMPAO Uptake in Frontal-Striatal Circuit on SPECT Scan

  Week 4

Study Arms (1)

EPI-743

EXPERIMENTAL

EPI-743- Participants will receive 200mg three times a day of EPI-743 for 2 weeks and then receive 300mg of EPI-743 for an additional 2 weeks.

Drug: EPI-743

Interventions

EPI-743 DRUG

EPI-743

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Yale University: lead
• Rembrandt Foundation: collaborator
• Edison Pharmaceuticals Inc: collaborator

Study Sites (1)

Yale Child Study Center

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Tourette Syndrome; Tics; Tic Disorders

Interventions

alpha-tocotrienol quinone

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael H Bloch, MD, MS

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2012
• First Posted: November 1, 2012
• Study Start: October 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: March 5, 2014

Record last verified: 2014-03

Locations

US (1)