Trial Outcomes & Findings for Tolerability, Safety, and Activity of SRX246 in Irritable Subjects With Huntington's Disease (NCT NCT02507284)
NCT ID: NCT02507284
Last Updated: 2023-07-20
Results Overview
The primary endpoint, tolerability of SRX246, was assessed by the number of completers in each group.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
106 participants
Primary outcome timeframe
12 weeks
Results posted on
2023-07-20
Participant Flow
Participant milestones
| Measure |
SRX246 120mg BID
SRX246 capsules, administered orally, in divided doses twice daily
SRX246
|
SRX246 160mg BID
SRX246 capsules, administered orally, in divided doses twice daily
SRX246
|
Placebo
Placebo capsules, administered orally, in divided doses twice daily
Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
36
|
34
|
36
|
|
Overall Study
COMPLETED
|
25
|
27
|
30
|
|
Overall Study
NOT COMPLETED
|
11
|
7
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tolerability, Safety, and Activity of SRX246 in Irritable Subjects With Huntington's Disease
Baseline characteristics by cohort
| Measure |
SRX246 120mg BID
n=36 Participants
SRX246 capsules, administered orally, in divided doses twice daily
SRX246
|
SRX246 160mg BID
n=34 Participants
SRX246 capsules, administered orally, in divided doses twice daily
SRX246
|
Placebo
n=36 Participants
Placebo capsules, administered orally, in divided doses twice daily
Placebo
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.1 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
48.9 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
51.7 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
50.6 years
STANDARD_DEVIATION 12.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
36 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not White
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic/Latino
|
34 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
99 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=5 Participants
|
34 participants
n=7 Participants
|
36 participants
n=5 Participants
|
106 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 weeksThe primary endpoint, tolerability of SRX246, was assessed by the number of completers in each group.
Outcome measures
| Measure |
SRX246 120mg BID
n=36 Participants
SRX246 capsules, administered orally, in divided doses twice daily
SRX246
|
SRX246 160mg BID
n=34 Participants
SRX246 capsules, administered orally, in divided doses twice daily
SRX246
|
Placebo
n=36 Participants
Placebo capsules, administered orally, in divided doses twice daily
Placebo
|
|---|---|---|---|
|
Tolerability of SRX246
|
25 Participants
|
27 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: 12 weeksThe Safety of SRX246 was assessed by the number of participants who experience an adverse event.
Outcome measures
| Measure |
SRX246 120mg BID
n=36 Participants
SRX246 capsules, administered orally, in divided doses twice daily
SRX246
|
SRX246 160mg BID
n=34 Participants
SRX246 capsules, administered orally, in divided doses twice daily
SRX246
|
Placebo
n=36 Participants
Placebo capsules, administered orally, in divided doses twice daily
Placebo
|
|---|---|---|---|
|
Safety of SRX246
|
29 Participants
|
30 Participants
|
26 Participants
|
Adverse Events
SRX246 120mg BID
Serious events: 5 serious events
Other events: 29 other events
Deaths: 0 deaths
SRX246 160mg BID
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SRX246 120mg BID
n=36 participants at risk
SRX246 capsules, administered orally, in divided doses twice daily. This group includes those participants that were enrolled and randomized to the group assigned to receive 120mg BID throughout the study. The data are reported based on 3 arms: SRX246 120mg, SRX246 160mg and Placebo. All subjects were randomized at the beginning of the study to one of these 3 arms. Thus, the data are displayed this way, even though all participants randomized to the SRX246 arms received a starting dose of SRX246 80mg, then escalated to SRX246 120mg, and then the group that was randomized to the SRX246 160mg was dose escalated.
|
SRX246 160mg BID
n=34 participants at risk
SRX246 capsules, administered orally, in divided doses twice daily. This group includes those participants that were enrolled and randomized to the group assigned to receive 160mg BID throughout the study. The data are reported based on 3 arms: SRX246 120mg, SRX246 160mg and Placebo. All subjects were randomized at the beginning of the study to one of those 3 arms. Thus, the data are displayed this way, even though all participants randomized to the SRX246 arms received a starting dose of SRX246 80mg, then escalated to SRX246 120mg, and then the group that was randomized to the SRX246 160mg was dose escalated.
|
Placebo
n=36 participants at risk
Placebo capsules, administered orally, in divided doses twice daily
|
|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
2.8%
1/36 • Number of events 1 • From first dose of study drug to last date of patient follow-up at end of study (an average of 12-weeks)
The data are reported based on 3 arms: SRX246 120mg, SRX246 160mg and Placebo. All subjects were randomized at the beginning of the study to one of those 3 arms. Thus, the data are displayed this way, even though all participants randomized to the SRX246 arms received a starting dose of SRX246 80mg, then escalated to SRX246 120mg, and then the group that was randomized to the SRX246 160mg was dose escalated.
|
0.00%
0/34 • From first dose of study drug to last date of patient follow-up at end of study (an average of 12-weeks)
The data are reported based on 3 arms: SRX246 120mg, SRX246 160mg and Placebo. All subjects were randomized at the beginning of the study to one of those 3 arms. Thus, the data are displayed this way, even though all participants randomized to the SRX246 arms received a starting dose of SRX246 80mg, then escalated to SRX246 120mg, and then the group that was randomized to the SRX246 160mg was dose escalated.
|
0.00%
0/36 • From first dose of study drug to last date of patient follow-up at end of study (an average of 12-weeks)
The data are reported based on 3 arms: SRX246 120mg, SRX246 160mg and Placebo. All subjects were randomized at the beginning of the study to one of those 3 arms. Thus, the data are displayed this way, even though all participants randomized to the SRX246 arms received a starting dose of SRX246 80mg, then escalated to SRX246 120mg, and then the group that was randomized to the SRX246 160mg was dose escalated.
|
|
Musculoskeletal and connective tissue disorders
Ankle fracture
|
2.8%
1/36 • Number of events 1 • From first dose of study drug to last date of patient follow-up at end of study (an average of 12-weeks)
The data are reported based on 3 arms: SRX246 120mg, SRX246 160mg and Placebo. All subjects were randomized at the beginning of the study to one of those 3 arms. Thus, the data are displayed this way, even though all participants randomized to the SRX246 arms received a starting dose of SRX246 80mg, then escalated to SRX246 120mg, and then the group that was randomized to the SRX246 160mg was dose escalated.
|
0.00%
0/34 • From first dose of study drug to last date of patient follow-up at end of study (an average of 12-weeks)
The data are reported based on 3 arms: SRX246 120mg, SRX246 160mg and Placebo. All subjects were randomized at the beginning of the study to one of those 3 arms. Thus, the data are displayed this way, even though all participants randomized to the SRX246 arms received a starting dose of SRX246 80mg, then escalated to SRX246 120mg, and then the group that was randomized to the SRX246 160mg was dose escalated.
|
0.00%
0/36 • From first dose of study drug to last date of patient follow-up at end of study (an average of 12-weeks)
The data are reported based on 3 arms: SRX246 120mg, SRX246 160mg and Placebo. All subjects were randomized at the beginning of the study to one of those 3 arms. Thus, the data are displayed this way, even though all participants randomized to the SRX246 arms received a starting dose of SRX246 80mg, then escalated to SRX246 120mg, and then the group that was randomized to the SRX246 160mg was dose escalated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
2.8%
1/36 • Number of events 1 • From first dose of study drug to last date of patient follow-up at end of study (an average of 12-weeks)
The data are reported based on 3 arms: SRX246 120mg, SRX246 160mg and Placebo. All subjects were randomized at the beginning of the study to one of those 3 arms. Thus, the data are displayed this way, even though all participants randomized to the SRX246 arms received a starting dose of SRX246 80mg, then escalated to SRX246 120mg, and then the group that was randomized to the SRX246 160mg was dose escalated.
|
0.00%
0/34 • From first dose of study drug to last date of patient follow-up at end of study (an average of 12-weeks)
The data are reported based on 3 arms: SRX246 120mg, SRX246 160mg and Placebo. All subjects were randomized at the beginning of the study to one of those 3 arms. Thus, the data are displayed this way, even though all participants randomized to the SRX246 arms received a starting dose of SRX246 80mg, then escalated to SRX246 120mg, and then the group that was randomized to the SRX246 160mg was dose escalated.
|
0.00%
0/36 • From first dose of study drug to last date of patient follow-up at end of study (an average of 12-weeks)
The data are reported based on 3 arms: SRX246 120mg, SRX246 160mg and Placebo. All subjects were randomized at the beginning of the study to one of those 3 arms. Thus, the data are displayed this way, even though all participants randomized to the SRX246 arms received a starting dose of SRX246 80mg, then escalated to SRX246 120mg, and then the group that was randomized to the SRX246 160mg was dose escalated.
|
|
Psychiatric disorders
Aggression and Irritability
|
5.6%
2/36 • Number of events 2 • From first dose of study drug to last date of patient follow-up at end of study (an average of 12-weeks)
The data are reported based on 3 arms: SRX246 120mg, SRX246 160mg and Placebo. All subjects were randomized at the beginning of the study to one of those 3 arms. Thus, the data are displayed this way, even though all participants randomized to the SRX246 arms received a starting dose of SRX246 80mg, then escalated to SRX246 120mg, and then the group that was randomized to the SRX246 160mg was dose escalated.
|
0.00%
0/34 • From first dose of study drug to last date of patient follow-up at end of study (an average of 12-weeks)
The data are reported based on 3 arms: SRX246 120mg, SRX246 160mg and Placebo. All subjects were randomized at the beginning of the study to one of those 3 arms. Thus, the data are displayed this way, even though all participants randomized to the SRX246 arms received a starting dose of SRX246 80mg, then escalated to SRX246 120mg, and then the group that was randomized to the SRX246 160mg was dose escalated.
|
0.00%
0/36 • From first dose of study drug to last date of patient follow-up at end of study (an average of 12-weeks)
The data are reported based on 3 arms: SRX246 120mg, SRX246 160mg and Placebo. All subjects were randomized at the beginning of the study to one of those 3 arms. Thus, the data are displayed this way, even though all participants randomized to the SRX246 arms received a starting dose of SRX246 80mg, then escalated to SRX246 120mg, and then the group that was randomized to the SRX246 160mg was dose escalated.
|
Other adverse events
| Measure |
SRX246 120mg BID
n=36 participants at risk
SRX246 capsules, administered orally, in divided doses twice daily. This group includes those participants that were enrolled and randomized to the group assigned to receive 120mg BID throughout the study. The data are reported based on 3 arms: SRX246 120mg, SRX246 160mg and Placebo. All subjects were randomized at the beginning of the study to one of these 3 arms. Thus, the data are displayed this way, even though all participants randomized to the SRX246 arms received a starting dose of SRX246 80mg, then escalated to SRX246 120mg, and then the group that was randomized to the SRX246 160mg was dose escalated.
|
SRX246 160mg BID
n=34 participants at risk
SRX246 capsules, administered orally, in divided doses twice daily. This group includes those participants that were enrolled and randomized to the group assigned to receive 160mg BID throughout the study. The data are reported based on 3 arms: SRX246 120mg, SRX246 160mg and Placebo. All subjects were randomized at the beginning of the study to one of those 3 arms. Thus, the data are displayed this way, even though all participants randomized to the SRX246 arms received a starting dose of SRX246 80mg, then escalated to SRX246 120mg, and then the group that was randomized to the SRX246 160mg was dose escalated.
|
Placebo
n=36 participants at risk
Placebo capsules, administered orally, in divided doses twice daily
|
|---|---|---|---|
|
Gastrointestinal disorders
nausea
|
19.4%
7/36 • Number of events 13 • From first dose of study drug to last date of patient follow-up at end of study (an average of 12-weeks)
The data are reported based on 3 arms: SRX246 120mg, SRX246 160mg and Placebo. All subjects were randomized at the beginning of the study to one of those 3 arms. Thus, the data are displayed this way, even though all participants randomized to the SRX246 arms received a starting dose of SRX246 80mg, then escalated to SRX246 120mg, and then the group that was randomized to the SRX246 160mg was dose escalated.
|
26.5%
9/34 • Number of events 13 • From first dose of study drug to last date of patient follow-up at end of study (an average of 12-weeks)
The data are reported based on 3 arms: SRX246 120mg, SRX246 160mg and Placebo. All subjects were randomized at the beginning of the study to one of those 3 arms. Thus, the data are displayed this way, even though all participants randomized to the SRX246 arms received a starting dose of SRX246 80mg, then escalated to SRX246 120mg, and then the group that was randomized to the SRX246 160mg was dose escalated.
|
11.1%
4/36 • Number of events 4 • From first dose of study drug to last date of patient follow-up at end of study (an average of 12-weeks)
The data are reported based on 3 arms: SRX246 120mg, SRX246 160mg and Placebo. All subjects were randomized at the beginning of the study to one of those 3 arms. Thus, the data are displayed this way, even though all participants randomized to the SRX246 arms received a starting dose of SRX246 80mg, then escalated to SRX246 120mg, and then the group that was randomized to the SRX246 160mg was dose escalated.
|
|
General disorders
Fatigue
|
8.3%
3/36 • Number of events 3 • From first dose of study drug to last date of patient follow-up at end of study (an average of 12-weeks)
The data are reported based on 3 arms: SRX246 120mg, SRX246 160mg and Placebo. All subjects were randomized at the beginning of the study to one of those 3 arms. Thus, the data are displayed this way, even though all participants randomized to the SRX246 arms received a starting dose of SRX246 80mg, then escalated to SRX246 120mg, and then the group that was randomized to the SRX246 160mg was dose escalated.
|
14.7%
5/34 • Number of events 7 • From first dose of study drug to last date of patient follow-up at end of study (an average of 12-weeks)
The data are reported based on 3 arms: SRX246 120mg, SRX246 160mg and Placebo. All subjects were randomized at the beginning of the study to one of those 3 arms. Thus, the data are displayed this way, even though all participants randomized to the SRX246 arms received a starting dose of SRX246 80mg, then escalated to SRX246 120mg, and then the group that was randomized to the SRX246 160mg was dose escalated.
|
5.6%
2/36 • Number of events 2 • From first dose of study drug to last date of patient follow-up at end of study (an average of 12-weeks)
The data are reported based on 3 arms: SRX246 120mg, SRX246 160mg and Placebo. All subjects were randomized at the beginning of the study to one of those 3 arms. Thus, the data are displayed this way, even though all participants randomized to the SRX246 arms received a starting dose of SRX246 80mg, then escalated to SRX246 120mg, and then the group that was randomized to the SRX246 160mg was dose escalated.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
16.7%
6/36 • Number of events 7 • From first dose of study drug to last date of patient follow-up at end of study (an average of 12-weeks)
The data are reported based on 3 arms: SRX246 120mg, SRX246 160mg and Placebo. All subjects were randomized at the beginning of the study to one of those 3 arms. Thus, the data are displayed this way, even though all participants randomized to the SRX246 arms received a starting dose of SRX246 80mg, then escalated to SRX246 120mg, and then the group that was randomized to the SRX246 160mg was dose escalated.
|
11.8%
4/34 • Number of events 4 • From first dose of study drug to last date of patient follow-up at end of study (an average of 12-weeks)
The data are reported based on 3 arms: SRX246 120mg, SRX246 160mg and Placebo. All subjects were randomized at the beginning of the study to one of those 3 arms. Thus, the data are displayed this way, even though all participants randomized to the SRX246 arms received a starting dose of SRX246 80mg, then escalated to SRX246 120mg, and then the group that was randomized to the SRX246 160mg was dose escalated.
|
25.0%
9/36 • Number of events 11 • From first dose of study drug to last date of patient follow-up at end of study (an average of 12-weeks)
The data are reported based on 3 arms: SRX246 120mg, SRX246 160mg and Placebo. All subjects were randomized at the beginning of the study to one of those 3 arms. Thus, the data are displayed this way, even though all participants randomized to the SRX246 arms received a starting dose of SRX246 80mg, then escalated to SRX246 120mg, and then the group that was randomized to the SRX246 160mg was dose escalated.
|
|
Injury, poisoning and procedural complications
Fall
|
11.1%
4/36 • Number of events 6 • From first dose of study drug to last date of patient follow-up at end of study (an average of 12-weeks)
The data are reported based on 3 arms: SRX246 120mg, SRX246 160mg and Placebo. All subjects were randomized at the beginning of the study to one of those 3 arms. Thus, the data are displayed this way, even though all participants randomized to the SRX246 arms received a starting dose of SRX246 80mg, then escalated to SRX246 120mg, and then the group that was randomized to the SRX246 160mg was dose escalated.
|
11.8%
4/34 • Number of events 7 • From first dose of study drug to last date of patient follow-up at end of study (an average of 12-weeks)
The data are reported based on 3 arms: SRX246 120mg, SRX246 160mg and Placebo. All subjects were randomized at the beginning of the study to one of those 3 arms. Thus, the data are displayed this way, even though all participants randomized to the SRX246 arms received a starting dose of SRX246 80mg, then escalated to SRX246 120mg, and then the group that was randomized to the SRX246 160mg was dose escalated.
|
13.9%
5/36 • Number of events 5 • From first dose of study drug to last date of patient follow-up at end of study (an average of 12-weeks)
The data are reported based on 3 arms: SRX246 120mg, SRX246 160mg and Placebo. All subjects were randomized at the beginning of the study to one of those 3 arms. Thus, the data are displayed this way, even though all participants randomized to the SRX246 arms received a starting dose of SRX246 80mg, then escalated to SRX246 120mg, and then the group that was randomized to the SRX246 160mg was dose escalated.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.9%
5/36 • Number of events 5 • From first dose of study drug to last date of patient follow-up at end of study (an average of 12-weeks)
The data are reported based on 3 arms: SRX246 120mg, SRX246 160mg and Placebo. All subjects were randomized at the beginning of the study to one of those 3 arms. Thus, the data are displayed this way, even though all participants randomized to the SRX246 arms received a starting dose of SRX246 80mg, then escalated to SRX246 120mg, and then the group that was randomized to the SRX246 160mg was dose escalated.
|
14.7%
5/34 • Number of events 6 • From first dose of study drug to last date of patient follow-up at end of study (an average of 12-weeks)
The data are reported based on 3 arms: SRX246 120mg, SRX246 160mg and Placebo. All subjects were randomized at the beginning of the study to one of those 3 arms. Thus, the data are displayed this way, even though all participants randomized to the SRX246 arms received a starting dose of SRX246 80mg, then escalated to SRX246 120mg, and then the group that was randomized to the SRX246 160mg was dose escalated.
|
2.8%
1/36 • Number of events 1 • From first dose of study drug to last date of patient follow-up at end of study (an average of 12-weeks)
The data are reported based on 3 arms: SRX246 120mg, SRX246 160mg and Placebo. All subjects were randomized at the beginning of the study to one of those 3 arms. Thus, the data are displayed this way, even though all participants randomized to the SRX246 arms received a starting dose of SRX246 80mg, then escalated to SRX246 120mg, and then the group that was randomized to the SRX246 160mg was dose escalated.
|
|
Nervous system disorders
headache
|
16.7%
6/36 • Number of events 7 • From first dose of study drug to last date of patient follow-up at end of study (an average of 12-weeks)
The data are reported based on 3 arms: SRX246 120mg, SRX246 160mg and Placebo. All subjects were randomized at the beginning of the study to one of those 3 arms. Thus, the data are displayed this way, even though all participants randomized to the SRX246 arms received a starting dose of SRX246 80mg, then escalated to SRX246 120mg, and then the group that was randomized to the SRX246 160mg was dose escalated.
|
11.8%
4/34 • Number of events 6 • From first dose of study drug to last date of patient follow-up at end of study (an average of 12-weeks)
The data are reported based on 3 arms: SRX246 120mg, SRX246 160mg and Placebo. All subjects were randomized at the beginning of the study to one of those 3 arms. Thus, the data are displayed this way, even though all participants randomized to the SRX246 arms received a starting dose of SRX246 80mg, then escalated to SRX246 120mg, and then the group that was randomized to the SRX246 160mg was dose escalated.
|
22.2%
8/36 • Number of events 9 • From first dose of study drug to last date of patient follow-up at end of study (an average of 12-weeks)
The data are reported based on 3 arms: SRX246 120mg, SRX246 160mg and Placebo. All subjects were randomized at the beginning of the study to one of those 3 arms. Thus, the data are displayed this way, even though all participants randomized to the SRX246 arms received a starting dose of SRX246 80mg, then escalated to SRX246 120mg, and then the group that was randomized to the SRX246 160mg was dose escalated.
|
|
Psychiatric disorders
depressed mood
|
22.2%
8/36 • Number of events 11 • From first dose of study drug to last date of patient follow-up at end of study (an average of 12-weeks)
The data are reported based on 3 arms: SRX246 120mg, SRX246 160mg and Placebo. All subjects were randomized at the beginning of the study to one of those 3 arms. Thus, the data are displayed this way, even though all participants randomized to the SRX246 arms received a starting dose of SRX246 80mg, then escalated to SRX246 120mg, and then the group that was randomized to the SRX246 160mg was dose escalated.
|
23.5%
8/34 • Number of events 9 • From first dose of study drug to last date of patient follow-up at end of study (an average of 12-weeks)
The data are reported based on 3 arms: SRX246 120mg, SRX246 160mg and Placebo. All subjects were randomized at the beginning of the study to one of those 3 arms. Thus, the data are displayed this way, even though all participants randomized to the SRX246 arms received a starting dose of SRX246 80mg, then escalated to SRX246 120mg, and then the group that was randomized to the SRX246 160mg was dose escalated.
|
11.1%
4/36 • Number of events 6 • From first dose of study drug to last date of patient follow-up at end of study (an average of 12-weeks)
The data are reported based on 3 arms: SRX246 120mg, SRX246 160mg and Placebo. All subjects were randomized at the beginning of the study to one of those 3 arms. Thus, the data are displayed this way, even though all participants randomized to the SRX246 arms received a starting dose of SRX246 80mg, then escalated to SRX246 120mg, and then the group that was randomized to the SRX246 160mg was dose escalated.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place