Safety, Tolerability and Activity of SRX246 in Adults With Intermittent Explosive Disorder (AVN009)
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ClinicalTrials.gov Identifier: NCT02055638 |
Recruitment Status :
Completed
First Posted : February 5, 2014
Results First Posted : October 29, 2019
Last Update Posted : October 29, 2019
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Tracking Information | |||
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First Submitted Date ICMJE | February 3, 2014 | ||
First Posted Date ICMJE | February 5, 2014 | ||
Results First Submitted Date ICMJE | January 17, 2018 | ||
Results First Posted Date ICMJE | October 29, 2019 | ||
Last Update Posted Date | October 29, 2019 | ||
Study Start Date ICMJE | May 2014 | ||
Actual Primary Completion Date | May 2016 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Safety and Tolerability, Measured as the Number of Participants With Adverse Events [ Time Frame: up to 8 weeks ] Number of participants with adverse events
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Original Primary Outcome Measures ICMJE |
safety and tolerability [ Time Frame: weekly up to 8 weeks ] physical exam, vital signs, electrocardiogram, hematology, serum chemistry, urinalysis, adverse event (AE)/serious adverse event (SAE) reports
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Change History | |||
Current Secondary Outcome Measures ICMJE | Not Provided | ||
Original Secondary Outcome Measures ICMJE |
Reduction in Total Aggression Score [ Time Frame: weekly up to 8 weeks ] Determine the activity of SRX246 in reducing aggression in IED patients using diagnostic questionnaires and interview sessions
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Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Safety, Tolerability and Activity of SRX246 in Adults With Intermittent Explosive Disorder | ||
Official Title ICMJE | An Exploratory Phase II Study to Determine the Safety, Tolerability and Activity of a Novel Vasopressin 1a Receptor Antagonist (SRX246) in Adults With Diagnostic and Statistical Manual Version 5 (DSM-5) Intermittent Explosive Disorder (IED) | ||
Brief Summary | This study is designed to explore the safety and tolerability, and to compare the activity of SRX246 against placebo, in adults with Intermittent Explosive Disorder (IED). Adult Male and Female subjects with a current diagnosis of IED will be enrolled. After a two-week baseline lead-in phase, study subjects who continue to meet enrollment criteria will be randomized to either SRX246 or Placebo treatment groups. Study subjects will be examined and asked to answer questionnaires at weekly scheduled visits throughout the trial. The study results will be determined based on any changes observed over the study period. |
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Detailed Description | This exploratory Phase II study has been designed to examine the safety and tolerability profile, and to compare the activity of the novel V1a vasopressin antagonist (SRX246) against placebo, in adults with DSM-5 Intermittent Explosive Disorder (IED). Adult Male and Female subjects with a current DSM-5 diagnosis of IED will be enrolled. All subjects will undergo systematic diagnostic assessment for DSM-5 Axis I and II disorders. Subjects with DSM-5 IED (without current, co-morbid, DSM-5 Major Depression) whose: (a) Life History of Aggression (LHA) score is > 12, (b) Overt Aggression Scale Modified (OAS-M) "Irritability" score is > 6 and, (c) screening OAS-M "Aggression" score is > 15, will be entered into a two-week baseline lead-in phase. After the lead-in phase, study subjects who continue to meet OAS-M criteria will be randomized to one of the two (2) treatment conditions and stratified by gender so that equal numbers of males and females are assigned to SRX246 and Placebo Groups. Those who do not meet the criteria will exit the protocol at that time. Treatment Conditions: (a) 8-week course of SRX246 (4 weeks at 120 mg bid, and 4 weeks at 160 mg bid) or (b) 8-week course of Placebo, followed by a one-week "taper" to withdraw subjects from study medication. IED subjects in all conditions will have structured diagnostic interview sessions and questionnaires administered throughout the trial. Blinding to treatment condition will be maintained by using different personnel for these activities. Analysis of a change from baseline in the diagnostic measures will be performed. |
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Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Intermittent Explosive Disorder | ||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
97 | ||
Original Estimated Enrollment ICMJE |
96 | ||
Actual Study Completion Date ICMJE | May 2016 | ||
Actual Primary Completion Date | May 2016 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 21 Years to 55 Years (Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT02055638 | ||
Other Study ID Numbers ICMJE | AVN009 | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Responsible Party | Azevan Pharmaceuticals | ||
Study Sponsor ICMJE | Azevan Pharmaceuticals | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Azevan Pharmaceuticals | ||
Verification Date | October 2019 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |