Trial Outcomes & Findings for Evaluation of SPN-812 (Viloxazine Extended-release Capsule) Low Dose in Adolescents With ADHD (NCT NCT03247517)
NCT ID: NCT03247517
Last Updated: 2021-06-18
Results Overview
The Primary Endpoint was the change from baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) Total score at Week 6 (End of Study). The ADHD-RS-5 is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology. The scale consists of 18 items that directly correspond to the 18 Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) symptoms of ADHD. Each item is rated on a 4-point Likert-type scale from 0 (never or rarely) to 3 (very often). A Total score is calculated by adding the responses of all 18 items (range: 0-54; the higher the score, the more severe the ADHD symptoms). Lower change from baseline scores (\<0) represent a better outcome.
COMPLETED
PHASE3
310 participants
Baseline and Week 6 (End of Study)
2021-06-18
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo oral capsule
Treatment A: Placebo will be administered once daily
|
200mg SPN-812
200mg SPN-812 oral capsule
Treatment B: SPN-812 was administered once daily and compared to placebo
|
400mg SPN-812
400mg SPN-812 oral capsule
Treatment C: SPN-812 was administered once daily and compared to placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
104
|
98
|
106
|
|
Overall Study
COMPLETED
|
96
|
78
|
92
|
|
Overall Study
NOT COMPLETED
|
8
|
20
|
14
|
Reasons for withdrawal
| Measure |
Placebo
Placebo oral capsule
Treatment A: Placebo will be administered once daily
|
200mg SPN-812
200mg SPN-812 oral capsule
Treatment B: SPN-812 was administered once daily and compared to placebo
|
400mg SPN-812
400mg SPN-812 oral capsule
Treatment C: SPN-812 was administered once daily and compared to placebo
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
4
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
6
|
4
|
|
Overall Study
Consent withdrawn by caregiver
|
1
|
4
|
7
|
|
Overall Study
Assent/consent withdrawn by subject
|
2
|
3
|
1
|
|
Overall Study
Protocol Violation
|
0
|
2
|
0
|
|
Overall Study
Multiple reasons
|
3
|
1
|
0
|
Baseline Characteristics
Evaluation of SPN-812 (Viloxazine Extended-release Capsule) Low Dose in Adolescents With ADHD
Baseline characteristics by cohort
| Measure |
Placebo
n=104 Participants
Placebo oral capsule
Treatment A: Placebo will be administered once daily
|
200mg SPN-812
n=94 Participants
200mg SPN-812 oral capsule
Treatment B: SPN-812 will be administered once daily and compared to placebo
|
400mg SPN-812
n=103 Participants
400mg SPN-812 oral capsule
Treatment C: SPN-812 will be administered once daily and compared to placebo
|
Total
n=301 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
13.8 years
STANDARD_DEVIATION 1.60 • n=5 Participants
|
13.9 years
STANDARD_DEVIATION 1.48 • n=7 Participants
|
14.0 years
STANDARD_DEVIATION 1.59 • n=5 Participants
|
13.9 years
STANDARD_DEVIATION 1.56 • n=4 Participants
|
|
Age, Customized
12 to 14 years
|
70 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
197 Participants
n=4 Participants
|
|
Age, Customized
15 to 17 years
|
34 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
104 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
110 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
191 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
30 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
74 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
212 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
39 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
118 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
63 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
171 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
104 participants
n=5 Participants
|
94 participants
n=7 Participants
|
103 participants
n=5 Participants
|
301 participants
n=4 Participants
|
|
ADHD-RS-5 Total Score
|
40.5 units on a scale
STANDARD_DEVIATION 6.79 • n=5 Participants
|
39.9 units on a scale
STANDARD_DEVIATION 7.22 • n=7 Participants
|
39.4 units on a scale
STANDARD_DEVIATION 7.59 • n=5 Participants
|
39.9 units on a scale
STANDARD_DEVIATION 7.20 • n=4 Participants
|
|
ADHD-RS-5 Inattention
|
22.4 units on a scale
STANDARD_DEVIATION 3.67 • n=5 Participants
|
22.2 units on a scale
STANDARD_DEVIATION 3.66 • n=7 Participants
|
21.5 units on a scale
STANDARD_DEVIATION 3.60 • n=5 Participants
|
22.0 units on a scale
STANDARD_DEVIATION 3.65 • n=4 Participants
|
|
ADHD-RS-5 Hyperactivity/Impulsivity
|
18.1 units on a scale
STANDARD_DEVIATION 5.35 • n=5 Participants
|
17.7 units on a scale
STANDARD_DEVIATION 5.71 • n=7 Participants
|
17.9 units on a scale
STANDARD_DEVIATION 5.64 • n=5 Participants
|
17.9 units on a scale
STANDARD_DEVIATION 5.55 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 6 (End of Study)Population: Intent-to-Treat (ITT) Population: The ITT population includes subjects who were randomized, took at least one dose of study medication, have a baseline Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) assessment and have at least one post-baseline ADHD-RS-5 assessment.
The Primary Endpoint was the change from baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) Total score at Week 6 (End of Study). The ADHD-RS-5 is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology. The scale consists of 18 items that directly correspond to the 18 Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) symptoms of ADHD. Each item is rated on a 4-point Likert-type scale from 0 (never or rarely) to 3 (very often). A Total score is calculated by adding the responses of all 18 items (range: 0-54; the higher the score, the more severe the ADHD symptoms). Lower change from baseline scores (\<0) represent a better outcome.
Outcome measures
| Measure |
Placebo
n=104 Participants
Placebo oral capsule
Treatment A: Placebo was administered once daily
|
200mg SPN-812
n=94 Participants
200mg SPN-812 oral capsule
Treatment B: SPN-812 was administered once daily and compared to placebo
|
400mg SPN-812
n=103 Participants
400mg SPN-812 oral capsule
Treatment C: SPN-812 was administered once daily and compared to placebo
|
|---|---|---|---|
|
Efficacy of SPN-812 Assessed by Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5)
|
-11.4 units on a scale
Standard Error 1.37
|
-16.0 units on a scale
Standard Error 1.45
|
-16.5 units on a scale
Standard Error 1.38
|
SECONDARY outcome
Timeframe: Week 6 (End of Study)Population: Intent-to-Treat (ITT) Population: The ITT population includes subjects who were randomized, took at least one dose of study medication, have a baseline Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) assessment and have at least one post-baseline ADHD-RS-5 assessment.
The first Key Secondary Endpoint was the Clinical Global Impression-Improvement (CGI-I) Scale score at Week 6 (End of Study). The CGI-I scale is a single item assessment of how much the patient's illness has improved or worsened relative to a baseline state prior to the beginning of treatment. The CGI-I is rated on a 7-point Likert scale from 1 to 7, where 1 = "very much improved" and 7 = "very much worse." Successful therapy is indicated by a lower overall score in subsequent testing.
Outcome measures
| Measure |
Placebo
n=104 Participants
Placebo oral capsule
Treatment A: Placebo was administered once daily
|
200mg SPN-812
n=94 Participants
200mg SPN-812 oral capsule
Treatment B: SPN-812 was administered once daily and compared to placebo
|
400mg SPN-812
n=103 Participants
400mg SPN-812 oral capsule
Treatment C: SPN-812 was administered once daily and compared to placebo
|
|---|---|---|---|
|
Effect of SPN-812 Assessed by Clinical Global Impression-Improvement (CGI-I) Scale
|
3.0 units on a scale
Standard Error 0.11
|
2.5 units on a scale
Standard Error 0.12
|
2.4 units on a scale
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Baseline and Week 6 (End of Study)Population: Intent-to-Treat (ITT) Population: The ITT population includes subjects who were randomized, took at least one dose of study medication, have a baseline Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) assessment and have at least one post-baseline ADHD-RS-5 assessment.
The second Key Secondary Endpoint was the change from baseline in the Conners 3rd Edition - Parent Short Form (C3PS) Composite T-score at Week 6 (End of Study). The Conners 3rd Edition is a focused diagnostic tool for the assessment of ADHD and associated learning, behavior, and emotional problems in children 6 to 18 years of age. The C3PS is completed by a child's parent/guardian and is comprised of 45 items with subsets of items related to six content scales: inattention, hyperactivity/impulsivity, executive functioning, learning problems, defiance/aggression and peer relations. The parent rates his/her child on the first 43 items of the C3PS using a 4-point Likert scale (0-3; where 0=not at all true \[never, seldom\] and 3=very much true \[very often, very frequently\]) based on past month; the last 2 items are fill-in-the-blank and do not contribute to the raw score(s). Raw scores are converted to T-scores. Lower change from baseline T-scores (\<0) represent a better outcome.
Outcome measures
| Measure |
Placebo
n=104 Participants
Placebo oral capsule
Treatment A: Placebo was administered once daily
|
200mg SPN-812
n=94 Participants
200mg SPN-812 oral capsule
Treatment B: SPN-812 was administered once daily and compared to placebo
|
400mg SPN-812
n=103 Participants
400mg SPN-812 oral capsule
Treatment C: SPN-812 was administered once daily and compared to placebo
|
|---|---|---|---|
|
Effect of SPN-812 Assessed by Conners 3rd Edition - Parent Short Form (C3-PS)
|
-5.7 T-score
Standard Error 1.04
|
-6.4 T-score
Standard Error 1.12
|
-8.6 T-score
Standard Error 1.07
|
SECONDARY outcome
Timeframe: Baseline and Week 6 (End of Study)Population: Intent-to-Treat (ITT) Population: The ITT population includes subjects who were randomized, took at least one dose of study medication, have a baseline Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) assessment and have at least one post-baseline ADHD-RS-5 assessment.
The third Key Secondary Endpoint was the change from baseline in the Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P) Total Average score at Week 6 (End of Study). The WFIRS instrument evaluates ADHD-related functional impairment. The WFIRS-P is completed by the child's parent/guardian and is comprised of 50 items grouped into six domains: Family (10 items), School (10 items, includes learning \[4 items\] and behavior \[6 items\]), Life Skills (10 items), Child's Self-Concept (3 items), Social Activities (7 items), and Risky Activities (10 items). The parent/guardian rates each item on a 4-point Likert scale (0-3; where 0=never or not at all to 3= very often or very much) based on their child's behavior past month. A Total Average score was computed by calculating mean rating of all 50 items (ranging from 0 to 3, where a higher value represents more severe functional impairment). Lower change from baseline Total Average scores (\<0) represent a better outcome.
Outcome measures
| Measure |
Placebo
n=104 Participants
Placebo oral capsule
Treatment A: Placebo was administered once daily
|
200mg SPN-812
n=94 Participants
200mg SPN-812 oral capsule
Treatment B: SPN-812 was administered once daily and compared to placebo
|
400mg SPN-812
n=103 Participants
400mg SPN-812 oral capsule
Treatment C: SPN-812 was administered once daily and compared to placebo
|
|---|---|---|---|
|
Effect of SPN-812 Assessed by Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)
|
-0.19 units on a scale
Standard Error 0.041
|
-0.27 units on a scale
Standard Error 0.045
|
-0.31 units on a scale
Standard Error 0.042
|
SECONDARY outcome
Timeframe: Week 6 (End of Study)Population: Intent-to-Treat (ITT) Population: The ITT population includes subjects who were randomized, took at least one dose of study medication, have a baseline Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) assessment and have at least one post-baseline ADHD-RS-5 assessment.
An additional secondary endpoint was the percentage of responders at Week 6 (End of Study). A responder was defined as a subject who had a 50% or greater reduction (improvement) in their change from baseline Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) Total score at Week 6 (End of Study). Values range from 0 to 100%. A higher percentage represents a greater number of responders.
Outcome measures
| Measure |
Placebo
n=104 Participants
Placebo oral capsule
Treatment A: Placebo was administered once daily
|
200mg SPN-812
n=94 Participants
200mg SPN-812 oral capsule
Treatment B: SPN-812 was administered once daily and compared to placebo
|
400mg SPN-812
n=103 Participants
400mg SPN-812 oral capsule
Treatment C: SPN-812 was administered once daily and compared to placebo
|
|---|---|---|---|
|
Effect of SPN-812 Assessed by 50% Responder Rate Per the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5)
|
27.0 percentage of subjects
|
45.8 percentage of subjects
|
44.6 percentage of subjects
|
SECONDARY outcome
Timeframe: Baseline and Week 6 (End of Study)Population: Intent-to-Treat (ITT) Population: The ITT population includes subjects who were randomized, took at least one dose of study medication, have a baseline Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) assessment and have at least one post-baseline ADHD-RS-5 assessment.
Another secondary endpoint was the change from baseline in the Stress Index for Parents of Adolescents (SIPA) Total score to Week 6 (End of Study). The SIPA is a 112-item screening/diagnostic instrument for parents of adolescents 11-19 years of age that identifies areas of stress in parent-adolescent interactions. Items 1-90 are rated on a 5-point Likert scale (where SD=Strongly Disagree, D=Disagree, NS=Not Sure, A=Agree, and SA=Strongly Agree) and yields a raw score for 3 Domains (Adolescent Domain, Parent Domain, and Adolescent-Parent Domain) that focus on a parent's perception of their child's personality and on the parent's characteristics and behaviors. The sum of the 3 Domain scores yields the Total (Parent Stress) score (range: 90-450; higher total scores indicate higher levels of stress). Lower change from baseline scores (\<0) represent a better outcome.
Outcome measures
| Measure |
Placebo
n=104 Participants
Placebo oral capsule
Treatment A: Placebo was administered once daily
|
200mg SPN-812
n=94 Participants
200mg SPN-812 oral capsule
Treatment B: SPN-812 was administered once daily and compared to placebo
|
400mg SPN-812
n=103 Participants
400mg SPN-812 oral capsule
Treatment C: SPN-812 was administered once daily and compared to placebo
|
|---|---|---|---|
|
Effect of SPN-812 Assessed by Stress Index for Parents of Adolescents (SIPA)
|
-13.7 units on a scale
Standard Error 3.72
|
-12.0 units on a scale
Standard Error 4.08
|
-15.3 units on a scale
Standard Error 3.83
|
SECONDARY outcome
Timeframe: Baseline and Week 6 (End of Study)Population: Intent-to-Treat (ITT) Population: The ITT population includes subjects who were randomized, took at least one dose of study medication, have a baseline Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) assessment and have at least one post-baseline ADHD-RS-5 assessment.
An additional secondary endpoint was the change from baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) Hyperactivity/Impulsivity subscale score and Inattention subscale score at Week 6 (End of Study). The ADHD-RS-5 is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology. The scale consists of 18 items that directly correspond to the 18 DSM-5 symptoms of ADHD, including 9 items for the Hyperactivity/Impulsivity subscale and 9 items for the Inattention subscale. Each item is rated on a 4-point Likert-type scale from 0 (never or rarely) to 3 (very often). Each subscale score is calculated by adding the responses of all respective 9 items (range: 0-27; the higher the subscale score, the more severe the Hyperactivity/Impulsivity or Inattention symptoms). Lower change from baseline subscale scores (\<0) represent a better outcome.
Outcome measures
| Measure |
Placebo
n=104 Participants
Placebo oral capsule
Treatment A: Placebo was administered once daily
|
200mg SPN-812
n=94 Participants
200mg SPN-812 oral capsule
Treatment B: SPN-812 was administered once daily and compared to placebo
|
400mg SPN-812
n=103 Participants
400mg SPN-812 oral capsule
Treatment C: SPN-812 was administered once daily and compared to placebo
|
|---|---|---|---|
|
Effect of SPN-812 Assessed by the Hyperactivity/Impulsivity Subscale and the Inattention Subscale of the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5)
Hyperactivity/Impulsivity subscale
|
-5.1 units on a scale
Standard Error 0.69
|
-7.7 units on a scale
Standard Error 0.73
|
-8.4 units on a scale
Standard Error 0.69
|
|
Effect of SPN-812 Assessed by the Hyperactivity/Impulsivity Subscale and the Inattention Subscale of the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5)
Inattention subscale
|
-6.6 units on a scale
Standard Error 0.74
|
-8.7 units on a scale
Standard Error 0.78
|
-8.7 units on a scale
Standard Error 0.74
|
SECONDARY outcome
Timeframe: Baseline and Week 6 (End of Study)Population: Intent-to-Treat (ITT) Population: The ITT population includes subjects who were randomized, took at least one dose of study medication, have a baseline Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) assessment and have at least one post-baseline ADHD-RS-5 assessment.
An additional secondary endpoint was the change from baseline in the Conners 3rd Edition - Self Report Short Form (C3-SRS) Composite T score at Week 6 (End of Study). The Conners 3rd Edition is a focused diagnostic tool for assessment of ADHD and associated learning, behavior, and emotional problems in children 6 to 18 years of age. The C3-SRS, which is only validated in children/adolescents 8-18 years of age, is comprised of 41 items with subsets of items related to five content scales: inattention, hyperactivity/impulsivity, learning problems, aggression and family relations. The subject rates himself/herself on the first 39 items of C3-SRS using a 4-point Likert scale (0-3; where 0=not at all true \[never, seldom\] and 3=very much true \[very often, very frequently\] based on past month; the last 2 items are fill-in-the-blank and do not contribute to the raw score(s). Raw scores are converted to T-scores. Lower change from baseline T-scores (\<0) represent a better outcome.
Outcome measures
| Measure |
Placebo
n=104 Participants
Placebo oral capsule
Treatment A: Placebo was administered once daily
|
200mg SPN-812
n=94 Participants
200mg SPN-812 oral capsule
Treatment B: SPN-812 was administered once daily and compared to placebo
|
400mg SPN-812
n=103 Participants
400mg SPN-812 oral capsule
Treatment C: SPN-812 was administered once daily and compared to placebo
|
|---|---|---|---|
|
Effect of SPN-812 Assessed by Conners 3rd Edition - Self Report Short Form (C3-SRS)
|
-4.4 T-score
Standard Error 0.82
|
-5.5 T-score
Standard Error 0.88
|
-4.5 T-score
Standard Error 0.83
|
SECONDARY outcome
Timeframe: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6Population: Intent-to-Treat (ITT) Population: The ITT population includes subjects who were randomized, took at least one dose of study medication, have a baseline Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) assessment and have at least one post-baseline ADHD-RS-5 assessment.
An additional secondary endpoint was the percentage of subjects who were "improved" by visit; "improved" was defined as a subject who had a Clinical Global Impression - Improvement (CGI-I) score of 1 = "Very Much Improved" or 2 = "Much Improved". Values range from 0 to 100%. A higher percentage represents a greater number of subjects who were "improved".
Outcome measures
| Measure |
Placebo
n=104 Participants
Placebo oral capsule
Treatment A: Placebo was administered once daily
|
200mg SPN-812
n=94 Participants
200mg SPN-812 oral capsule
Treatment B: SPN-812 was administered once daily and compared to placebo
|
400mg SPN-812
n=103 Participants
400mg SPN-812 oral capsule
Treatment C: SPN-812 was administered once daily and compared to placebo
|
|---|---|---|---|
|
Effect of SPN-812 Assessed by Categorical Clinical Global Impression - Improvement (CGI-I) [the Percentage of Subjects Who Were 'Improved"]
Week 1
|
4.8 percentage of subjects
|
14.1 percentage of subjects
|
16.5 percentage of subjects
|
|
Effect of SPN-812 Assessed by Categorical Clinical Global Impression - Improvement (CGI-I) [the Percentage of Subjects Who Were 'Improved"]
Week 2
|
17.0 percentage of subjects
|
27.0 percentage of subjects
|
32.1 percentage of subjects
|
|
Effect of SPN-812 Assessed by Categorical Clinical Global Impression - Improvement (CGI-I) [the Percentage of Subjects Who Were 'Improved"]
Week 3
|
21.9 percentage of subjects
|
39.8 percentage of subjects
|
46.3 percentage of subjects
|
|
Effect of SPN-812 Assessed by Categorical Clinical Global Impression - Improvement (CGI-I) [the Percentage of Subjects Who Were 'Improved"]
Week 4
|
28.5 percentage of subjects
|
49.4 percentage of subjects
|
55.6 percentage of subjects
|
|
Effect of SPN-812 Assessed by Categorical Clinical Global Impression - Improvement (CGI-I) [the Percentage of Subjects Who Were 'Improved"]
Week 5
|
32.5 percentage of subjects
|
51.9 percentage of subjects
|
53.7 percentage of subjects
|
|
Effect of SPN-812 Assessed by Categorical Clinical Global Impression - Improvement (CGI-I) [the Percentage of Subjects Who Were 'Improved"]
Week 6
|
31.6 percentage of subjects
|
50.7 percentage of subjects
|
51.9 percentage of subjects
|
Adverse Events
Placebo
200mg SPN-812
400mg SPN-812
Serious adverse events
| Measure |
Placebo
n=104 participants at risk
Placebo oral capsule
Treatment A: Placebo will be administered once daily
|
200mg SPN-812
n=99 participants at risk
200mg SPN-812 oral capsule
Treatment B: SPN-812 was administered once daily and compared to placebo
|
400mg SPN-812
n=105 participants at risk
400mg SPN-812 oral capsule
Treatment C: SPN-812 was administered once daily and compared to placebo
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/104 • 6 weeks
The number of subjects reported in each arm for Adverse Events table is based on the Safety Population (actual treatment arm); includes subjects who were randomized and took at least one dose of study medication. One subject was randomized to the 400mg SPN-812 arm (assigned treatment arm), but received 200mg SPN-812 during the trial (actual treatment arm). Therefore, the number of participants between SPN-812 arms will differ by 1 between the Participant Flow table and Adverse Events table.
|
1.0%
1/99 • 6 weeks
The number of subjects reported in each arm for Adverse Events table is based on the Safety Population (actual treatment arm); includes subjects who were randomized and took at least one dose of study medication. One subject was randomized to the 400mg SPN-812 arm (assigned treatment arm), but received 200mg SPN-812 during the trial (actual treatment arm). Therefore, the number of participants between SPN-812 arms will differ by 1 between the Participant Flow table and Adverse Events table.
|
0.00%
0/105 • 6 weeks
The number of subjects reported in each arm for Adverse Events table is based on the Safety Population (actual treatment arm); includes subjects who were randomized and took at least one dose of study medication. One subject was randomized to the 400mg SPN-812 arm (assigned treatment arm), but received 200mg SPN-812 during the trial (actual treatment arm). Therefore, the number of participants between SPN-812 arms will differ by 1 between the Participant Flow table and Adverse Events table.
|
|
Nervous system disorders
Syncope
|
0.00%
0/104 • 6 weeks
The number of subjects reported in each arm for Adverse Events table is based on the Safety Population (actual treatment arm); includes subjects who were randomized and took at least one dose of study medication. One subject was randomized to the 400mg SPN-812 arm (assigned treatment arm), but received 200mg SPN-812 during the trial (actual treatment arm). Therefore, the number of participants between SPN-812 arms will differ by 1 between the Participant Flow table and Adverse Events table.
|
1.0%
1/99 • 6 weeks
The number of subjects reported in each arm for Adverse Events table is based on the Safety Population (actual treatment arm); includes subjects who were randomized and took at least one dose of study medication. One subject was randomized to the 400mg SPN-812 arm (assigned treatment arm), but received 200mg SPN-812 during the trial (actual treatment arm). Therefore, the number of participants between SPN-812 arms will differ by 1 between the Participant Flow table and Adverse Events table.
|
0.00%
0/105 • 6 weeks
The number of subjects reported in each arm for Adverse Events table is based on the Safety Population (actual treatment arm); includes subjects who were randomized and took at least one dose of study medication. One subject was randomized to the 400mg SPN-812 arm (assigned treatment arm), but received 200mg SPN-812 during the trial (actual treatment arm). Therefore, the number of participants between SPN-812 arms will differ by 1 between the Participant Flow table and Adverse Events table.
|
Other adverse events
| Measure |
Placebo
n=104 participants at risk
Placebo oral capsule
Treatment A: Placebo will be administered once daily
|
200mg SPN-812
n=99 participants at risk
200mg SPN-812 oral capsule
Treatment B: SPN-812 was administered once daily and compared to placebo
|
400mg SPN-812
n=105 participants at risk
400mg SPN-812 oral capsule
Treatment C: SPN-812 was administered once daily and compared to placebo
|
|---|---|---|---|
|
Nervous system disorders
Somnolence
|
7.7%
8/104 • 6 weeks
The number of subjects reported in each arm for Adverse Events table is based on the Safety Population (actual treatment arm); includes subjects who were randomized and took at least one dose of study medication. One subject was randomized to the 400mg SPN-812 arm (assigned treatment arm), but received 200mg SPN-812 during the trial (actual treatment arm). Therefore, the number of participants between SPN-812 arms will differ by 1 between the Participant Flow table and Adverse Events table.
|
13.1%
13/99 • 6 weeks
The number of subjects reported in each arm for Adverse Events table is based on the Safety Population (actual treatment arm); includes subjects who were randomized and took at least one dose of study medication. One subject was randomized to the 400mg SPN-812 arm (assigned treatment arm), but received 200mg SPN-812 during the trial (actual treatment arm). Therefore, the number of participants between SPN-812 arms will differ by 1 between the Participant Flow table and Adverse Events table.
|
14.3%
15/105 • 6 weeks
The number of subjects reported in each arm for Adverse Events table is based on the Safety Population (actual treatment arm); includes subjects who were randomized and took at least one dose of study medication. One subject was randomized to the 400mg SPN-812 arm (assigned treatment arm), but received 200mg SPN-812 during the trial (actual treatment arm). Therefore, the number of participants between SPN-812 arms will differ by 1 between the Participant Flow table and Adverse Events table.
|
|
Nervous system disorders
Headache
|
9.6%
10/104 • 6 weeks
The number of subjects reported in each arm for Adverse Events table is based on the Safety Population (actual treatment arm); includes subjects who were randomized and took at least one dose of study medication. One subject was randomized to the 400mg SPN-812 arm (assigned treatment arm), but received 200mg SPN-812 during the trial (actual treatment arm). Therefore, the number of participants between SPN-812 arms will differ by 1 between the Participant Flow table and Adverse Events table.
|
10.1%
10/99 • 6 weeks
The number of subjects reported in each arm for Adverse Events table is based on the Safety Population (actual treatment arm); includes subjects who were randomized and took at least one dose of study medication. One subject was randomized to the 400mg SPN-812 arm (assigned treatment arm), but received 200mg SPN-812 during the trial (actual treatment arm). Therefore, the number of participants between SPN-812 arms will differ by 1 between the Participant Flow table and Adverse Events table.
|
12.4%
13/105 • 6 weeks
The number of subjects reported in each arm for Adverse Events table is based on the Safety Population (actual treatment arm); includes subjects who were randomized and took at least one dose of study medication. One subject was randomized to the 400mg SPN-812 arm (assigned treatment arm), but received 200mg SPN-812 during the trial (actual treatment arm). Therefore, the number of participants between SPN-812 arms will differ by 1 between the Participant Flow table and Adverse Events table.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/104 • 6 weeks
The number of subjects reported in each arm for Adverse Events table is based on the Safety Population (actual treatment arm); includes subjects who were randomized and took at least one dose of study medication. One subject was randomized to the 400mg SPN-812 arm (assigned treatment arm), but received 200mg SPN-812 during the trial (actual treatment arm). Therefore, the number of participants between SPN-812 arms will differ by 1 between the Participant Flow table and Adverse Events table.
|
5.1%
5/99 • 6 weeks
The number of subjects reported in each arm for Adverse Events table is based on the Safety Population (actual treatment arm); includes subjects who were randomized and took at least one dose of study medication. One subject was randomized to the 400mg SPN-812 arm (assigned treatment arm), but received 200mg SPN-812 during the trial (actual treatment arm). Therefore, the number of participants between SPN-812 arms will differ by 1 between the Participant Flow table and Adverse Events table.
|
8.6%
9/105 • 6 weeks
The number of subjects reported in each arm for Adverse Events table is based on the Safety Population (actual treatment arm); includes subjects who were randomized and took at least one dose of study medication. One subject was randomized to the 400mg SPN-812 arm (assigned treatment arm), but received 200mg SPN-812 during the trial (actual treatment arm). Therefore, the number of participants between SPN-812 arms will differ by 1 between the Participant Flow table and Adverse Events table.
|
|
Gastrointestinal disorders
Nausea
|
2.9%
3/104 • 6 weeks
The number of subjects reported in each arm for Adverse Events table is based on the Safety Population (actual treatment arm); includes subjects who were randomized and took at least one dose of study medication. One subject was randomized to the 400mg SPN-812 arm (assigned treatment arm), but received 200mg SPN-812 during the trial (actual treatment arm). Therefore, the number of participants between SPN-812 arms will differ by 1 between the Participant Flow table and Adverse Events table.
|
7.1%
7/99 • 6 weeks
The number of subjects reported in each arm for Adverse Events table is based on the Safety Population (actual treatment arm); includes subjects who were randomized and took at least one dose of study medication. One subject was randomized to the 400mg SPN-812 arm (assigned treatment arm), but received 200mg SPN-812 during the trial (actual treatment arm). Therefore, the number of participants between SPN-812 arms will differ by 1 between the Participant Flow table and Adverse Events table.
|
6.7%
7/105 • 6 weeks
The number of subjects reported in each arm for Adverse Events table is based on the Safety Population (actual treatment arm); includes subjects who were randomized and took at least one dose of study medication. One subject was randomized to the 400mg SPN-812 arm (assigned treatment arm), but received 200mg SPN-812 during the trial (actual treatment arm). Therefore, the number of participants between SPN-812 arms will differ by 1 between the Participant Flow table and Adverse Events table.
|
|
General disorders
Fatigue
|
0.96%
1/104 • 6 weeks
The number of subjects reported in each arm for Adverse Events table is based on the Safety Population (actual treatment arm); includes subjects who were randomized and took at least one dose of study medication. One subject was randomized to the 400mg SPN-812 arm (assigned treatment arm), but received 200mg SPN-812 during the trial (actual treatment arm). Therefore, the number of participants between SPN-812 arms will differ by 1 between the Participant Flow table and Adverse Events table.
|
4.0%
4/99 • 6 weeks
The number of subjects reported in each arm for Adverse Events table is based on the Safety Population (actual treatment arm); includes subjects who were randomized and took at least one dose of study medication. One subject was randomized to the 400mg SPN-812 arm (assigned treatment arm), but received 200mg SPN-812 during the trial (actual treatment arm). Therefore, the number of participants between SPN-812 arms will differ by 1 between the Participant Flow table and Adverse Events table.
|
5.7%
6/105 • 6 weeks
The number of subjects reported in each arm for Adverse Events table is based on the Safety Population (actual treatment arm); includes subjects who were randomized and took at least one dose of study medication. One subject was randomized to the 400mg SPN-812 arm (assigned treatment arm), but received 200mg SPN-812 during the trial (actual treatment arm). Therefore, the number of participants between SPN-812 arms will differ by 1 between the Participant Flow table and Adverse Events table.
|
Additional Information
Joseph Hull, PhD, Associate Director Clinical Research
Supernus
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER