Open-Trial of EPI-743 for Adults With Tourette Syndrome
This study is currently recruiting participants.
Verified October 2012 by Yale University
Sponsor:
Yale University
Collaborators:
Rembrandt Foundation
Edison Pharmaceuticals Inc
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01719523
First received: October 29, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
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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 ]
| Estimated Enrollment: | 10 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01719523
Contacts
| Contact: Jilian Mulqueen, BA | 203 737-4809 | jilian.mulqueen@yale.edu |
Locations
| United States, Connecticut | |
| Yale Child Study Center | Recruiting |
| New Haven, Connecticut, United States, 06520 | |
| Contact: Jilian Mulqueen, BA 203-737-4809 jilian.mulqueen@yale.edu | |
| Principal Investigator: Michael H Bloch, MD, MS | |
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: | October 29, 2012 |
| 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 May 16, 2013