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

This study has been completed.
Sponsor:
Collaborators:
Rembrandt Foundation
Edison Pharmaceuticals Inc
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01719523
First received: October 29, 2012
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Tourette Syndrome
Drug: EPI-743
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Trial of EPI-743 for Adults With Tourette Syndrome

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Yale Global Tic Severity Scale [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Yale Global Tic Severity Scale [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Yale Global Tic Severity Scale [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Premonitory Urge for Tics Scale [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Yale-Brown Obsessive Compulsive Scale [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Connors Adult Attention Deficit Hyperactivity Rating Scale [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Hamilton Rating Scales for Depression and Anxiety [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Clinical Global Improvement [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Columbia Suicide Severity Rating Scale [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
  • Adverse Events Rating Scale [ Time Frame: Week 2 ] [ Designated as safety issue: Yes ]
  • Premonitory Urge for Tics Scale [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Premonitory Urge for Tics Scale [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Adverse Events Rating Scale [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
  • Yale-Brown Obsessive Compulsive Scale [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Yale-Brown Obsessive Compulsive Scale [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Connors Adult Attention Deficit Hyperactivity Rating Scale [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Connors Adult Attention Deficit Hyperactivity Rating Scale [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Hamilton Rating Scales for Depression and Anxiety [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Hamilton Rating Scales for Depression and Anxiety [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Clinical Global Improvement [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Columbia Suicide Severity Rating Scale [ Time Frame: Week 2 ] [ Designated as safety issue: Yes ]
  • Columbia Suicide Severity Rating Scale [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • HMPAO Uptake in Frontal-Striatal Circuit on SPECT Scan [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • HMPAO Uptake in Frontal-Striatal Circuit on SPECT Scan [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: October 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EPI-743
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01719523

Locations
United States, Connecticut
Yale Child Study Center
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
Rembrandt Foundation
Edison Pharmaceuticals Inc
Investigators
Principal Investigator: Michael H Bloch, MD, MS Yale University
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01719523     History of Changes
Other Study ID Numbers: 120100953972412
Study First Received: October 29, 2012
Last Updated: March 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Yale University:
Tourette syndrome
Tics
Tic Disorders

Additional relevant MeSH terms:
Tourette Syndrome
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tic Disorders
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014