Trial Outcomes & Findings for Safety, Tolerability and Activity of SRX246 in Adults With Intermittent Explosive Disorder (NCT NCT02055638)

NCT ID: NCT02055638

Last Updated: 2023-07-21

Results Overview

measured as the number of participants with adverse events

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 97 participants
• Primary outcome timeframe: from initial dose of intervention until completion of the study up to 8 weeks
• Results posted on: 2023-07-21

Participant Flow

One additional subject was enrolled than planned, due to timing of screening and notification to sites of ceasing planned enrollment.

Participant milestones

Measure	SRX246 SRX246 capsules, 120mg bid for 4 weeks followed by 160mg bid for 4 weeks SRX246: capsules	Placebo Placebo capsules to match the amount of SRX246 capsules for 8 weeks Placebo
Overall Study STARTED	49	48
Overall Study COMPLETED	39	40
Overall Study NOT COMPLETED	10	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	SRX246 n=49 Participants SRX246 capsules, 120mg bid for 4 weeks followed by 160mg bid for 4 weeks SRX246: capsules	Placebo n=48 Participants Placebo capsules to match the amount of SRX246 capsules for 8 weeks Placebo	Total n=97 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	49 Participants n=5 Participants	48 Participants n=7 Participants	97 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	28 Participants n=7 Participants	57 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	45 Participants n=5 Participants	43 Participants n=7 Participants	88 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	29 Participants n=5 Participants	31 Participants n=7 Participants	60 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	12 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	49 Participants n=5 Participants	48 Participants n=7 Participants	97 Participants n=5 Participants

PRIMARY outcome

Timeframe: from initial dose of intervention until completion of the study up to 8 weeks

Population: Intent to treat

measured as the number of participants with adverse events

Outcome measures

Measure	SRX246 n=49 Participants SRX246 capsules, 120mg bid for 4 weeks followed by 160mg bid for 4 weeks SRX246: capsules	Placebo n=48 Participants Placebo capsules to match the amount of SRX246 capsules for 8 weeks Placebo
Safety and Tolerability adverse events (AE)	28 participants	21 participants
Safety and Tolerability serious adverse events (SAE)	0 participants	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Comparison of baseline score to score at end of treatment period of 8 weeks

Population: those that took study drug and had sufficient data for analysis

Change from Baseline OAS-M Score. Higher values represent a worse outcome. The OAS-M contains 3 scales: Aggression (Questions [Q]1 to 4), Irritability (Q5 to 6), and Suicidality (Q7 to 7b). Aggression total score was calculated by summing the weighted scores in Q1 to 4. Scores for each question ranged from 0 (no events) to 5 (very severe events). Total scores ranged from 0 (no aggression) to any number with no upper limit depending on the frequency of aggressive behavior in a week.

Outcome measures

Measure	SRX246 n=39 Participants SRX246 capsules, 120mg bid for 4 weeks followed by 160mg bid for 4 weeks SRX246: capsules	Placebo n=41 Participants Placebo capsules to match the amount of SRX246 capsules for 8 weeks Placebo
Overt Aggression Scale Modified (OAS-M) Total Aggression Score	-29.55 score on a scale Standard Deviation 37.343	-30.43 score on a scale Standard Deviation 34.082

Adverse Events

SRX246

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	SRX246 n=49 participants at risk SRX246 capsules, 120mg bid for 4 weeks followed by 160mg bid for 4 weeks SRX246: capsules	Placebo n=48 participants at risk Placebo capsules to match the amount of SRX246 capsules for 8 weeks Placebo
Nervous system disorders Headache	6.1% 3/49 • Number of events 3 • from first dose of study drug to last follow-up visit, up to 8 weeks	6.2% 3/48 • Number of events 3 • from first dose of study drug to last follow-up visit, up to 8 weeks
Gastrointestinal disorders Diarrhea	6.1% 3/49 • Number of events 3 • from first dose of study drug to last follow-up visit, up to 8 weeks	4.2% 2/48 • Number of events 2 • from first dose of study drug to last follow-up visit, up to 8 weeks
Gastrointestinal disorders Dry Mouth	6.1% 3/49 • Number of events 3 • from first dose of study drug to last follow-up visit, up to 8 weeks	4.2% 2/48 • Number of events 2 • from first dose of study drug to last follow-up visit, up to 8 weeks

Additional Information

Dr. Neal Simon, CEO

Azevan Pharmaceuticals, Inc.

Phone: (610) 419-1057

Email: ngsimon@azevan.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place