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Safety, Tolerability and Activity of SRX246 in Adults With Intermittent Explosive Disorder (AVN009)

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: NCT02055638
Recruitment Status : Completed
First Posted : February 5, 2014
Results First Posted : October 29, 2019
Last Update Posted : October 29, 2019
Sponsor:
Information provided by (Responsible Party):
Azevan Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Intermittent Explosive Disorder
Interventions Drug: SRX246
Drug: Placebo
Enrollment 97
Recruitment Details  
Pre-assignment Details One additional subject was enrolled than planned, due to timing of screening and notification to sites of ceasing planned enrollment.
Arm/Group Title SRX246 Placebo
Hide Arm/Group Description

SRX246 capsules, 120mg bid for 4 weeks followed by 160mg bid for 4 weeks

SRX246: capsules

Placebo capsules to match the amount of SRX246 capsules for 8 weeks

Placebo

Period Title: Overall Study
Started 49 48
Completed 39 40
Not Completed 10 8
Arm/Group Title SRX246 Placebo Total
Hide Arm/Group Description

SRX246 capsules, 120mg bid for 4 weeks followed by 160mg bid for 4 weeks

SRX246: capsules

Placebo capsules to match the amount of SRX246 capsules for 8 weeks

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 49 48 97
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 48 participants 97 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
49
 100.0%
48
 100.0%
97
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 48 participants 97 participants
Female
20
  40.8%
20
  41.7%
40
  41.2%
Male
29
  59.2%
28
  58.3%
57
  58.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 48 participants 97 participants
Hispanic or Latino
3
   6.1%
4
   8.3%
7
   7.2%
Not Hispanic or Latino
45
  91.8%
43
  89.6%
88
  90.7%
Unknown or Not Reported
1
   2.0%
1
   2.1%
2
   2.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 48 participants 97 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
29
  59.2%
31
  64.6%
60
  61.9%
White
16
  32.7%
12
  25.0%
28
  28.9%
More than one race
3
   6.1%
4
   8.3%
7
   7.2%
Unknown or Not Reported
1
   2.0%
1
   2.1%
2
   2.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 49 participants 48 participants 97 participants
49
 100.0%
48
 100.0%
97
 100.0%
1.Primary Outcome
Title Safety and Tolerability, Measured as the Number of Participants With Adverse Events
Hide Description Number of participants with adverse events
Time Frame up to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat
Arm/Group Title SRX246 Placebo
Hide Arm/Group Description:

SRX246 capsules, 120mg bid for 4 weeks followed by 160mg bid for 4 weeks

SRX246: capsules

Placebo capsules to match the amount of SRX246 capsules for 8 weeks

Placebo

Overall Number of Participants Analyzed 49 48
Measure Type: Number
Unit of Measure: participants
adverse events (AE) 28 21
serious adverse events (SAE) 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SRX246 Placebo
Hide Arm/Group Description

SRX246 capsules, 120mg bid for 4 weeks followed by 160mg bid for 4 weeks

SRX246: capsules

Placebo capsules to match the amount of SRX246 capsules for 8 weeks

Placebo

All-Cause Mortality
SRX246 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/49 (0.00%)      0/48 (0.00%)    
Hide Serious Adverse Events
SRX246 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/49 (0.00%)      0/48 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SRX246 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/49 (18.37%)      7/48 (14.58%)    
Gastrointestinal disorders     
Diarrhea   3/49 (6.12%)  3 2/48 (4.17%)  2
Dry Mouth   3/49 (6.12%)  3 2/48 (4.17%)  2
Nervous system disorders     
Headache   3/49 (6.12%)  3 3/48 (6.25%)  3
Indicates events were collected by systematic assessment
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. Neal Simon, CEO
Organization: Azevan Pharmaceuticals, Inc.
Phone: (610) 419-1057
EMail: ngsimon@azevan.com
Layout table for additonal information
Responsible Party: Azevan Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02055638    
Other Study ID Numbers: AVN009
First Submitted: February 3, 2014
First Posted: February 5, 2014
Results First Submitted: January 17, 2018
Results First Posted: October 29, 2019
Last Update Posted: October 29, 2019