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Ecopipam Treatment of Tourette Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01244633
Recruitment Status : Completed
First Posted : November 19, 2010
Results First Posted : September 29, 2015
Last Update Posted : September 29, 2015
Sponsor:
Information provided by (Responsible Party):
Psyadon Pharma

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Tourette's Syndrome
Intervention Drug: Ecopipam
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ecopipam
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Active treatment

Ecopipam: 50 or 100 mg tablets given once per day for eight weeks

Period Title: Overall Study
Started 18
Completed 15
Not Completed 3
Arm/Group Title Ecopipam
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Active treatment

Ecopipam: 50 or 100 mg tablets given once per day for eight weeks

Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
<=18 years
0
   0.0%
Between 18 and 65 years
18
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
36  (15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
3
  16.7%
Male
15
  83.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants
18
1.Primary Outcome
Title Yale Global Tic Severity Score
Hide Description The Yale Global Tic Severity Score is a composite of subject reported severity of motor (range 0-25) and vocal (range 0-25) tics , as well as an impairment score (range 0-50). The outcome we are using is the Total Tic Severity score which is the sum of the motor and vocal tic severity scores (range 0-50). The higher the score on this scale, the more severe the symptoms. A positive drug effect is associated with a decrease from baseline.
Time Frame 8 weeks
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Hide Analysis Population Description
Subjects completing the study
Arm/Group Title Ecopipam
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Active treatment

Ecopipam: 50 or 100 mg tablets given once per day for eight weeks

Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
25.3  (9.2)
2.Secondary Outcome
Title Adult Attention Deficit/Hyperactivity Disorder (ADHD) Self-report Symptom Checklist (ASRS)
Hide Description This is a standard measure of ADHD severity that is typically used in these types of clinical trials.
Time Frame Every 7 days
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Hamilton Depression Scale
Hide Description This is a measure of feelings of depression that the patient might have.
Time Frame Every 7 days
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Premonitory Urge for Tics Scale (PUTS-1)
Hide Description This is a measure of the tic behavior that is seen in Tourette's patients, and it is typically used in these types of trials.
Time Frame Every 7 days
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Clinician Global Impression – Improvement and Severity Scales (CGI)
Hide Description This is a measure of how the treating physician perceives the effectiveness of a drug treatment, and it is typically used in these types of clinical trials.
Time Frame End of trial
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Safety Assessments
Hide Description Patients will be evaluated for any adverse events, and they will have a variety of blood tests to examine if any changes occur.
Time Frame Every 7 days
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Columbia Scale for Suicide Risk
Hide Description This test monitors whether the patient has any feelings of committing self-harm. It is mandated by the FDA to include this scale in all clinical trials of new central nervous system drugs.
Time Frame Every 7 days
Outcome Measure Data Not Reported
Time Frame 8 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ecopipam
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Active treatment

Ecopipam: 50 or 100 mg tablets given once per day for eight weeks

All-Cause Mortality
Ecopipam
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ecopipam
Affected / at Risk (%)
Total   0/18 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ecopipam
Affected / at Risk (%)
Total   6/18 (33.33%) 
Nervous system disorders   
Insomnia * 1  6/18 (33.33%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (12.0)
This was an open label study with no placebo control
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Richard Chipkin
Organization: Psyadon Pharmaceuticals
Phone: 3019192020
EMail: rchipkin@psyadonrx.com
Layout table for additonal information
Responsible Party: Psyadon Pharma
ClinicalTrials.gov Identifier: NCT01244633     History of Changes
Other Study ID Numbers: PSY301
First Submitted: November 17, 2010
First Posted: November 19, 2010
Results First Submitted: March 12, 2015
Results First Posted: September 29, 2015
Last Update Posted: September 29, 2015