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Ecopipam Treatment of Self-Injurious Behavior in Subjects With Lesch-Nyhan Disease

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ClinicalTrials.gov Identifier: NCT01751802
Recruitment Status : Terminated (Study terminated for commercial reasons)
First Posted : December 18, 2012
Results First Posted : October 8, 2015
Last Update Posted : October 8, 2015
Sponsor:
Information provided by (Responsible Party):
Psyadon Pharma

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Lesch-Nyhan Disease
Self-injurious Behavior
Interventions: Drug: Ecopipam
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ecopipam Then Placebo Then Ecopipam Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks
Placebo Then Ecopipam Then Placebo Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks

Participant Flow:   Overall Study
    Ecopipam Then Placebo Then Ecopipam   Placebo Then Ecopipam Then Placebo
STARTED   5   4 
Completed Period 1   2   4 
Completed Period 2   2   1 
Completed Period 3   2   1 
COMPLETED   1   2 
NOT COMPLETED   4   2 
Adverse Event                4                2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ecopipam Then Placebo Then Ecopipam Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks
Placebo Then Ecopipam Then Placebo Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks
Total Total of all reporting groups

Baseline Measures
   Ecopipam Then Placebo Then Ecopipam   Placebo Then Ecopipam Then Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 5   4   9 
Age 
[Units: Years]
Mean (Full Range)
 10.8 
 (6 to 22) 
 9.8 
 (6 to 12) 
 10.3 
 (6 to 22) 
Gender 
[Units: Participants]
     
Female   0   0   0 
Male   5   4   9 
Region of Enrollment 
[Units: Participants]
     
United States   2   1   3 
Spain   3   3   6 
Weight 
[Units: Kg]
Mean (Full Range)
 28.3 
 (16.5 to 55.4) 
 21.9 
 (16.0 to 26.5) 
 25.4 
 (16.0 to 55.4) 
BMI 
[Units: Kg/m^2]
Mean (Full Range)
 15.6 
 (13.9 to 18.1) 
 13.8 
 (13.1 to 15.5) 
 14.8 
 (13.1 to 18.1) 


  Outcome Measures

1.  Primary:   Behavior Problems Inventory - Self-Injurious Behavior Subscale   [ Time Frame: Baseline, end of period 1 (6 weeks), end of period 2 (12 weeks), end of period 3 (18 weeks), ]

2.  Secondary:   Effect of Ecopipam Withdrawal and Maintenance   [ Time Frame: Baseline, 6 weeks, 12 weeks, 18 weeks ]

3.  Secondary:   Safety Summary of Ecopipam in Patients With Lesch-Nyhan Disease: Total Number of Serious and Non-Serious Adverse Events Experienced During 3 Double-blind Crossover Periods   [ Time Frame: Total duration over which participants recieved double-blind ecopipam or placebo, up to 6 or 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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:  
Name/Title: President/CEO
Organization: Psyadon Pharmaceuticals
phone: 301-919-2020
e-mail: info@psyadonrx.com



Responsible Party: Psyadon Pharma
ClinicalTrials.gov Identifier: NCT01751802     History of Changes
Other Study ID Numbers: PSY102
First Submitted: December 14, 2012
First Posted: December 18, 2012
Results First Submitted: October 5, 2015
Results First Posted: October 8, 2015
Last Update Posted: October 8, 2015