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Trial record 6 of 134 for:    "Tourette Syndrome"

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

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ClinicalTrials.gov Identifier: NCT01719523
Recruitment Status : Completed
First Posted : November 1, 2012
Last Update Posted : March 5, 2014
Sponsor:
Collaborators:
Rembrandt Foundation
Edison Pharmaceuticals Inc
Information provided by (Responsible Party):
Yale University

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

Condition or disease Intervention/treatment Phase
Tourette Syndrome Drug: EPI-743 Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Trial of EPI-743 for Adults With Tourette Syndrome
Study Start Date : October 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Yale Global Tic Severity Scale [ Time Frame: Baseline ]
  2. Yale Global Tic Severity Scale [ Time Frame: 2 weeks ]
  3. Yale Global Tic Severity Scale [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Premonitory Urge for Tics Scale [ Time Frame: Baseline ]
  2. Yale-Brown Obsessive Compulsive Scale [ Time Frame: Baseline ]
  3. Connors Adult Attention Deficit Hyperactivity Rating Scale [ Time Frame: Baseline ]
  4. Hamilton Rating Scales for Depression and Anxiety [ Time Frame: Baseline ]
  5. Clinical Global Improvement [ Time Frame: Week 4 ]
  6. Columbia Suicide Severity Rating Scale [ Time Frame: Baseline ]
  7. Adverse Events Rating Scale [ Time Frame: Week 2 ]
  8. Premonitory Urge for Tics Scale [ Time Frame: Week 2 ]
  9. Premonitory Urge for Tics Scale [ Time Frame: Week 4 ]
  10. Adverse Events Rating Scale [ Time Frame: Week 4 ]
  11. Yale-Brown Obsessive Compulsive Scale [ Time Frame: Week 2 ]
  12. Yale-Brown Obsessive Compulsive Scale [ Time Frame: Week 4 ]
  13. Connors Adult Attention Deficit Hyperactivity Rating Scale [ Time Frame: Week 2 ]
  14. Connors Adult Attention Deficit Hyperactivity Rating Scale [ Time Frame: Week 4 ]
  15. Hamilton Rating Scales for Depression and Anxiety [ Time Frame: Week 2 ]
  16. Hamilton Rating Scales for Depression and Anxiety [ Time Frame: Week 4 ]
  17. Clinical Global Improvement [ Time Frame: Week 2 ]
  18. Columbia Suicide Severity Rating Scale [ Time Frame: Week 2 ]
  19. Columbia Suicide Severity Rating Scale [ Time Frame: Week 4 ]

Other Outcome Measures:
  1. HMPAO Uptake in Frontal-Striatal Circuit on SPECT Scan [ Time Frame: Baseline ]
  2. HMPAO Uptake in Frontal-Striatal Circuit on SPECT Scan [ Time Frame: Week 4 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01719523     History of Changes
Other Study ID Numbers: 120100953972412
First Posted: November 1, 2012    Key Record Dates
Last Update Posted: March 5, 2014
Last Verified: March 2014

Keywords provided by Yale University:
Tourette syndrome
Tics
Tic Disorders

Additional relevant MeSH terms:
Tourette Syndrome
Syndrome
Disease
Pathologic Processes
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
Neurodevelopmental Disorders
Mental Disorders
Ubiquinone
Micronutrients
Growth Substances
Physiological Effects of Drugs